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The Independent Evaluation of 'Starting
Well' Final Report
Part 2. Outcomes from Starting Well
2. Assessing Impact: the Quasi-Experimental
Study
Key findings: - Almost 50% (627/1321) of eligible families
were recruited between 01/06/01 and 30/06/02;
367 from intervention areas and 260 from
comparison areas receiving the generic
service.
- Cross-sectional analyses concentrated on
359 participants completing both baseline and
6-month assessments and 294 completing all
three assessments to 18-months.
- Comparisons of aggregate-level routine data
on opt-ins and opt-outs suggest no obvious bias
associated with recruitment or persistence in
the study.
- Multivariate regression analysis revealed:
significantly lower rates of
depressive symptoms amongst
intervention mothers at 6 but not 18-months; no
improvement in the
quality of the home
environment at 6-months but a small
positive effect of the intervention at
18-months (p=0.088); higher levels of
client-satisfaction with
levels of health visitor
support and higher levels of
dental registration at both
assessments.
- Despite doubts as to the transferability of
the north American evidence-base to the British
context, and a number of evaluation
limitations, findings relating to maternal
depressive symptoms and HOME score are
supportive of shorter-term psychological
benefits for study mothers and potentially
longer-term cognitive and emotional
developmental benefits for study children.
|
2.1 Introduction
An established literature suggests that home-based
interventions delivered by trained health professionals can
improve a range of outcomes for vulnerable pre-school children
(Olds and Kitzman 1993; Brooks-Gunn et al 2000; Elkan et al,
2000; Bull et al, 2004). Most studies do not have sufficient
numbers of participants to detect direct improvements in child
health (e.g. lower morbidity and/or mortality rates) but show
improvements in related factors, for example, quality of the
home environment (Davis and Spurr, 1998), detection and
management of postnatal depression (Holden et al, 1989) and
improved rates of breastfeeding (Kitzman et al, 1997). In
addition, long-term cohort studies show the benefits of
home-visiting to be diverse and enduring for both mother and
child (Olds et al,1997; 1998).
One acknowledged limitation of this largely American-based
literature is its lack of direct applicability to the British
context
16, specifically, its focus on specialist programmes that
exist in the absence of a universal health-visiting service.
The purpose of this evaluation component is not to establish
the impact of a service relative to its absence but to explore
the impact of an enhanced service ('Starting Well') on a group
of families over the first eighteen months of the child's life
relative to a group receiving the established (generic)
service.
In this section, we first describe key features of the study
design and characteristics of the recruited sample. This
section (2.2) includes an exploration of sample
representativeness using aggregate-level routine data on
opt-ins and opt-outs. In section 2.3, we present the results of
multivariate analysis of three health-related outcomes (quality
of the home environment, extent of maternal depressive
symptoms, child dental registration rates) and one measure of
user-satisfaction (with levels of health visitor support) at
both six and eighteen month assessments. In section 2.4 we
discuss the implications of these findings.
2.2 Methods
2.2.1 Target populations
The intervention population was defined as all births
visited by Starting Well health visitors between 01/06/01 and
31/06/02 within the project's strict geographical boundaries
17. Statistics on the total number of births were generated
by the project team's interrogation of the study database. The
comparison population was defined as all births
18 assigned to health-visiting teams working in the Northern
Local Health Care Co-operative over the same time period.
Comparison 'area' health visitors are attached to particular GP
practices and, as they only visit families that are registered
at that surgery, there is a strong but not defining geographic
focus to their work
19. Consent to evaluation was lower than expected in the
comparison area and consequently recruitment was extended to a
further two health visiting teams in the west of Glasgow
(Drumchapel and Clydebank) between 01/04/02 and 31/06/02. The
total numbers of comparison area births was calculated by the
NHS data provider
20 from the interrogation of routine data sources. Table 2.1
shows the total number of births and opt-ins by group
21.
Table 2.1: Total number of births and
opt-ins.
| Comparison | Intervention | All |
Opt-ins | 260 | 367 | 627 |
Opt-outs | 415 | 279 | 694 |
Total births | 675 | 646 | 1321 |
Sample as % of population | 38.5 | 56.8 | 47.5 |
Just under 50% of eligible families opted into the
evaluation, proportionally more so from the intervention
area(s). This is perhaps unsurprising given the implicit
incentive of receiving the enhanced service.
2.2.2 Procedure
Each opt-in parent/family received a baseline postal survey.
This was sent out as soon as the consent form was received from
the attending health visitor, in most cases, within two months
of the child's birth. The survey covered: background maternal,
household and area characteristics; maternal mental health and
health behaviour; and attitudes towards parenting and current
health-visiting service. Interpreters were made available to
assist participants with no or limited English (n=21) and
completed surveys were returned using a pre-paid envelope.
Participants with overdue surveys were followed up by letter
and phone. Further surveys were sent out to each participant
when their child was six and then eighteen months old. Content
focussed on mother-reported child outcomes and updates of
maternal health, support and attitudes to the health visiting
service.
In addition, each participant that could be contacted at six
and eighteen months received a home visit from one of three
trained research nurses who administered the HOME Inventory.
The average interview lasted around one hour. At the end of the
interview, the nurse administered several additional survey
instruments (e.g. the Edinburgh Postnatal Depression Scale) and
retrieved any incomplete or unsent postal surveys. Again,
interpreters were available for non-English speakers.
Table 2.2: Returns per assessment by
group
| N | Totals as % of
…. |
COMP | INT | Total | Sample
(n=627) | Population (n=1321) |
Baseline survey | 180 | 267 | 447 | 71.3 | 33.8 |
6-month survey | 198 | 292 | 490 | 78.2 | 37.1 |
18-month survey | 185 | 252 | 437 | 69.7 | 33.1 |
| | | | | |
6-month HOME | 192 | 301 | 493 | 78.6 | 37.3 |
18-month HOME | 196 | 252 | 431 | 68.7 | 32.6 |
Note: COMP = comparison group; INT = intervention group
Table 2.2 shows the number of returns by assessment and
group with totals expressed as percentages of sample and
population. In data not shown, similar fieldwork completion
rates were observed at both assessments across cohorts. Contact
by research nurses at six months produced a better survey
return rate than baseline postal methods, although this
advantage was offset at eighteen months by attrition of
subjects. The populations from which the cohorts are drawn are
residentially mobile and at the time of writing, 73 (11.6%) of
the original sample had either voluntarily withdrawn from the
study (n=26) or moved house without leaving a forwarding
address (n=47).
Table 2.3: 'Rich' six and eighteen months
datasets as a proportion of sample and
population
| N | Totals as % of…. |
COMP
| INT
| Total | Sample (n=627) | Population (n=1321) |
Baseline & 6-month assessments | 146 | 213 | 359 | 57.3 | 27.1 |
Baseline, 6 & 18-month assessments | 122 | 172 | 294 | 46.9 | 22.3 |
All data were collated and stored securely at the study
offices, before being coded and entered. Table 2.3 shows the
percentage of participants who completed all instruments at six
months (n=359) and eighteen months (n=294). A further 93
participants were not seen at baseline but completed a brief
retrospective survey at six months, covering basic child,
maternal and household characteristics. For the purposes of
this report, richness of data is considered to be more
important than maximising the number of subjects; analysis
therefore concentrates on the two smaller datasets
22.
2.2.3 Sample characteristics and
representativeness
The preceding section showed that not all eligible families
opted into the study and, of those who did, not all could be
contacted at all assessments. This introduces two potential
sources of bias, both of which must be understood in order to
be able to generalise confidently from results. The first
source of bias relates to
recruitment and the possibility that there are
systematic outcome-related differences between those who opted
into the study and those who opted out. By definition, little
or no information is available on opt-outs, however, by gaining
ethical permission and signed consent to collect
individual-level routine data on opt-ins (e.g. from the Child
Health Surveillance system), the NHS data provider was able to
'subtract' these children from the known population of eligible
births and generate limited aggregate-level comparative
statistics on the remainder (i.e. the opt-outs). Tables 2.4a
and b show the results of these comparisons, together with p
values for associated comparisons of proportions and means
respectively. Note that variable (and occasionally substantial)
numbers of missing values are a feature of the data.
Table 2.4a: Characteristics of opt-outs and
opt-ins (frequencies)
| OPT-OUTS | OPT-INS | p |
Variable | n/total n | valid % | n/total n | valid % |
minority ethnic mothers | 85/606 | 14 | 60/559 | 10.8 | .087 |
first-time mothers | 311/644 | 48.3 | 272/578 | 47.1 | .687 |
smoked in pregnancy | 231/604 | 38.2 | 249/592 | 42.1 | .178 |
male child | 360/669 | 53.8 | 284/578 | 49.1 | .099 |
low birthweight (<2500g) | 67/572 | 10.7 | 76/532 | 13.1 | .204 |
Breastfeeding at first health visitor visit | 171/624 | 27.4 | 162/598 | 27.1 | .902 |
Breastfeeding at 6-week check up | 130/572 | 22.7 | 115/565 | 20.4 | .330 |
maximum n | 694 | | 627 | | |
Table 2.4b: Characteristics of opt-outs and
opt-ins (means)
| OPT-OUTS (max n = 694) | OPT-INS (max n = 627) | p |
Variable | mean (s.d.) | range | n | mean (s.d.) | range | n |
mother's age | 27.3 (6.3) | 14-43 | 581 | 27.2 (6.5) | 15-44 | 566 | .79 |
father's age | 29.8 (6.7) | 15-51 | 530 | 29.6 (7.2) | 16-62 | 525 | .64 |
gestation (weeks) | 39.1 (2) | 27-43 | 619 | 39 (2) | 26-43 | 573 | .39 |
birth weight (grams) | 3233.9 (612.5) | 880-5260 | 568 | 3186.8 (588.3) | 1180-4740 | 532 | .19 |
The tables show that compared to opt-outs, opt-in mothers
were less likely to be from minority ethnic backgrounds and
more likely to have smoked during pregnancy and to have lower
birthweight children. However, Howevcomparison of proportions
and means suggested no statistically significant differences at
the 95% level on any of the above measures. Hence, there is no
obvious evidence of bias associated with recruitment.
A second potential source of bias relates to
attrition and/or participation in assessment; the
possibility that participants included in analysis (i.e. the
'rich' datasets of people completing all assessments) are
systematically different from opt-ins as a whole. In analyses
not shown, we have compared all opt-ins and sub-groups on a
number of measures using both routine and survey data and find
that persistence in the study is very moderately associated
with greater relative affluence and maternal age. Whilst some
differences approach significance at the p=0.05 level, the
large numbers of comparisons involved greatly increases the
risk of a type one (false positive) error and we cannot
confidently conclude that there is any bias associated with
persistence in the study.
Finally, in this sub-section, we shift the comparative focus
away from opt-ins and opt-outs to describe some salient
characteristics of the groups of participants included in
analysis. Table 2.5 shows a series of survey items relating to
both ethnicity and disadvantage for participants included in
the six-month analysis (n=359). Similar figures are obtained
for the eighteen month dataset (see above). The table makes two
principal points: first, that all minority ethnic participants
are in the intervention group
23; and second, that on a number of measures, the comparison
group are relatively more affluent in what may be regarded as a
generally socio-economically disadvantaged cohort
24.
Table 2.5:Comparison of selected baseline
characteristics by group (n=359 dataset)
| Comparison | Intervention | p |
variable | n | % | n | % |
minority ethnic mother | 0 | 0 | 34 | 16 | <.001 |
mother has no qualifications | 26 | 17.8 | 52 | 24.4 | .13 |
no car in household | 55 | 37.7 | 92 | 43.2 | .30 |
not homeowner | 75 | 51.4 | 134 | 62.9 | .03 |
workless households | 39 | 26.7 | 77 | 36.2 | .06 |
higher income households (>1000/month after
tax) | 72 | 49.3 | 59 | 27.7 | <.001 |
2.2.4 Measures
Outcome variables
Three measures relating to child health and one measuring
user-satisfaction were chosen as outcomes at six and eighteen
months. The first two health-related measures - quality of the
home environment and extent of maternal depressive symptoms -
are chosen firstly, because of their proven association with
later child cognitive and emotional development (Bradley, 1993;
Murray and Cooper, 1997) and secondly, because well-validated
instruments exist to measure them (Bradley and Caldwell, 1988;
Cox, Holden and Sagovsky, 1987). The third outcome - the
child's dental registration status as reported by the mother -
was chosen as an indicator of oral health, an area in which the
programme is trying to promote positive change. The final
outcome - satisfaction with the levels of health visitor
support - is chosen as a key comparative indicator of
user-satisfaction
25.
Turning to each outcome in detail, the first is derived from
the Infant/Toddler version of the HOME Inventory (Bradley and
Caldwell, 1979b; Caldwell and Bradley, 1984). The HOME (Home
Observation and Measurement of the Environment) is a
standardised interview-and-observation tool that assesses the
quantity and quality of stimulation available to a child in its
home environment. Administered by trained researchers (usually
health professionals), the assessment takes the form of a home
interview with the caregiver and index child present. The
interviewer asks a set of questions about the child's 'typical'
day and in conjunction with more general observation, scores
the mother-child dyad on the presence versus absence of 45 key
responses and behaviours (for example, 'mother responds to
child's vocalisations with a verbal response'). Six sub-scale
scores are produced: verbal and emotional responsivity;
acceptance of sub-optimal behaviour; degree of organisation of
the child's temporal and physical environment; provision of
learning materials; active involvement in learning; and
inclusion of variety in the child's life. A higher score
indicates a 'better' environment, i.e. one that is richer in
terms of quality and/or quantity of stimulation. In keeping
with many studies, we use the overall total score, i.e. the sum
of all sub-scales, as our principal outcome.
The second outcome measure derives from another
standardised, validated instrument - the Edinburgh Postnatal
Depression Scale (EPDS; Cox, Holden and Sagovsky, 1987. See
Appendix III for full instrument). This instrument is widely
used as a screening tool for suspected postpartum depression.
Participants indicate their strength of agreement with ten
mood-related statement (for example, 'I have looked forward
with enjoyment to things') and receive a total score ranging
from 0-30, where a higher score means 'more depressive
symptoms'. In this study, we used a dichotomised measure based
on the advisory threshold score for clinical action: a score of
13 or greater was coded as '1'. It is to be stressed that the
EPDS is a screening tool and scores exceeding this threshold do
not equate to a formal diagnosis of depression. However,
validation studies suggest that a threshold set at this value
correctly identifies around two-thirds of depressed women
(Murray and Carothers, 1990).
The third outcome used here is a dichotomised mother-report
measure derived from a survey item.
Dental registration indicates whether the child is
registered with a community dentist at the time of assessment
('yes' = 1; 'no' or 'don't know' = 0). As this is a
mother-reported measure, it awaits validation from routine data
sources.
Finally, responses to the item 'how satisfied are you with
the general level of support you have been receiving from your
health visitor?' ('very satisfied'; 'fairly satisfied'; 'not
very satisfied'; 'not satisfied at all') were dichotomised so
that 'very satisfied' was coded as '1'.
Baseline predictor variables
A general aim of the quasi-experimental study is to explore
the effects of the intervention on child health whilst
controlling for the many individual- and household-level
confounding factors. Accordingly, many such variables were
included in the baseline survey, a sub-sample of which with
a priori associations to outcomes were used in
exploratory multivariate analysis. A full list of measures are
available on request but the main sets of baseline predictors
include: survey items relating to basic maternal and child data
(child's gender, gestation, birth weight, feeding and
behaviour, parity, mother's age, etc); items covering maternal
health and health behaviour adapted from the 1998 Scottish
Health Survey (Scottish Executive, 1998); self-control and
alienation sub-scales from the Multidimensional Personality
Questionnaire (MPQ: Tellegen et al, 1982); the Rosenberg
Self-Esteem Scale (Rosenberg, 1965); the DUKE-UNC Functional
Support Scale (Broadhead, 1988); questions on attitudes to
parenting and health-visiting; and items taken from the 2001 UK
Decennial Census, for example highest maternal qualification,
household employment, tenure and car ownership.
Baseline socio-economic status was constructed from
employment-related survey items using the reduced 2001 National
Statistics Socio-Economic Classification system (NS-SEC; The
Stationery Office, 2002). Some analytic classes were merged due
to low counts, resulting in the following four dichotomised
variables: NS-SEC class 1 and 2 (professional, managerial and
higher technical occupations); NS-SEC classes 3, 4 and 5
(intermediate, lower supervisory and technical occupations);
NS-SEC 6 and 7 (routine and semi-routine occupations); NS-SEC
class 8 (never worked and long-term unemployed).
Material circumstances were indexed via a self-report
measure of household income (after tax). This ordinal measure
(participants ticked one of nine income bands, e.g. '200-299')
was recoded into three dichotomised variables: lower income
(<400/month); medium income (400 - 999/month) and higher
income (>1000/month).
Service input was measured by collecting individual-level
routine data on the number and type of contacts (including
failed contacts) with health visitors and associated
professionals. These data were collated from an operational
database in the intervention area and from health visitor notes
in the comparison area. Whilst a number of measures could be
constructed, problems of comparability across cohorts meant
that only two - the total number of recorded home visits by
health visitors between 0-6 and 6-18 months respectively - were
used in analysis
26. These measures are likely to be reliable as health
visitors are more likely to recall and record face-to-face
contact in the client's home than brief phone contacts or
opportunistic encounters at a clinic or in the street.
Table 2.6 shows the mean number of visits of this type at
six and eighteen months, for both n=359 and n=294 datasets. All
between-group comparisons were highly significant (t-values and
dfs available on request). Although these figures confirm and
emphasise the more intensive and home-based nature of the
intervention, reference to both standard deviations and the
range suggests considerable variation in the number of visits;
evidently both types of service have the capacity to be
flexible.
Table 2.6: Description of health visitor home
visits at each assessment
| | COMPARISON | INTERVENTION | p |
Dataset (n) | Visits from… | mean (s.d.) | range | mean (s.d.) | range |
6 month (359) | 0-6 months | 3.5 (2.3) | 0-16 | 9.1 (4.2) | 0-24 | <0.001 |
18 month (294) | 0-6 months | 3.3 (2.2) | 1-16 | 9.2 (4.2) | 0-24 | <0.001 |
| 6-18 months | 0.8 (1.4) | 0-9 | 4.6 (3.9) | 0-26 | <0.001 |
Finally, in order to test for intervention effects,
intervention status was entered into analysis as a property of
each individual family (i.e., intervention family coded as '1',
comparison family as '0').
2.2.5 Statistical approach.
Stepwise ordinary least squares (OLS) regression was
performed on the HOME total score and logistic regression on
the three dichotomous outcomes. Our general approach was
iterative and cumulative and involved initial stepwise
experimentation with reduced models containing similar
variables (e.g. relating to material circumstances) whilst
always retaining five key control variables: mother's age;
parity; ethnicity; child's gender and group (intervention vs.
comparison). We entered the strongest predictors in the reduced
models into a full model whilst again retaining key variables.
Overall, we have tried to produce robust models that satisfy
three modelling criteria:
a priori reasoning; statistical significance; and
parsimony in the number of variables retained in the final
equation.
2.3 Outcomes at six and eighteen months
2.3.1 Notes on the interpretation of statistics in
this section
The meaning of 'significance' in descriptive and
inferential statistics sub-sections:
If we had adopted an 'experimental' (e.g. randomised control
trial) design with
random allocation of births to different treatment
conditions, we would not expect there to be any meaningful
differences between groups apart from the treatment/service
they received. In these circumstances, 'simple' comparisons of
proportions and means like those in the descriptive statistics
sub-sections of this chapter would be sufficient to demonstrate
the presence/absence of 'real' (i.e. unbiased and statistically
significant) group differences. However, the area-based nature
of 'Starting Well' necessitated the adoption of a
quasi-experimental design where births were non-randomly
assigned to groups based on where their parents lived. This
means that comparisons of the intervention and control groups
may be biased by differences other than the service they
receive. The regression analyses enable us to adjust for these
differences to provide a less biased estimate of the
intervention effect. However, it can only be used to adjust for
observed differences between the groups, and unobserved
differences may still bias the comparison in either
direction.
Regression statistics:
Regression statistics express the size and direction of an
association between a predictor variable and an outcome, whilst
statistically controlling for the influence of other predictor
variables in the model. In OLS regression (the analysis carried
out on the HOME score), attention should be directed to the
'standardised beta coefficient' where a positive value
indicates a positive independent association between that
predictor and the outcome, whilst a negative value indicates a
negative association. Within any given model, a higher
standardised beta indicates a stronger relative effect
27. Similarly, the key statistic in logistic regression is
the odds-ratio (OR). An OR of less than 1 indicates a negative
independent relationship between that predictor variable and
the outcome whilst an OR of greater than 1 indicates a positive
relationship. All predictor variables retained in models have
an associated probability statistic. We use the conventional
statistical significance criterion of p<0.05.
2.3.2 Health-related outcomes
Descriptive statistics
Table 2.7 shows between-group descriptive statistics for
three health-related outcomes at six and eighteen months. The
comparison area cohort has a non-significantly higher total
HOME score at both assessments although the magnitude of the
difference is less at eighteen months. HOME scores tend to
increase over time. In contrast, identical proportions of women
score above EPDS threshold at six months but there are
significantly fewer comparison area women in this group at the
later assessment (c
2=3.89, dfs=1). Finally, the intervention group had
higher rates of dental registration at both assessments,
although this is only statistically significant at six months
(c
2=13.43, dfs=1).
Table 2.7 descriptive statistics for three
health-related outcomes at six- and eighteen
months
| GROUP | difference | p |
comparison | intervention |
HOME score: mean (s.d.) |
At 6-months | 35.4 (4.1) | 34.5 (5.1) | -.94 | .07 |
At 18-months | 38.2 (4.7) | 37.4 (5.3) | -.78 | .20 |
EPDS: % scoring 13+ |
At 6-months | 16.4 | 16.4 | 0 | - |
At 18-months | 10.0 | 18.2 | + 8.2 | .05 |
Dental registration: %
registered |
At 6-months | 26.0 | 45.1 | +19.1 | <0.001 |
At 18-months | 73.8 | 82.5 | + 8.7 | .07 |
N at 6 months | 146 | 213 | | |
N at 18 months | 122 | 172 | | |
Inferential statistics
Table 2.8 shows the final models obtained at six and
eighteen months for OLS regression of the total HOME score.
Five variables were significantly and independently associated
with outcome at both assessments, indicating the basic
similarity of the models. Other predictors appear only once,
either because they did not fit the model or were novel
variables entered at eighteen months (e.g. mother's
self-control). No statistically significant intervention effect
was found at the p=0.05 level although the association was
positive at both assessments and at eighteen months
was significant at the p=0.10 level. Elsewhere,
mother's age and ethnicity were strongly associated with the
total HOME score (although in opposite directions) whilst
first-time mothers scored more highly at the first assessment
but did not show this advantage at eighteen months. Other
maternal characteristics, indexing dimensions of personality
and (perhaps) levels of personal resources, also predicted
outcome: mothers with high self-esteem scored more highly at
six months, but impulsive mothers, single mothers and those
with more resident children tended to achieve lower scores.
Finally, there is a negative association between household
income and HOME score at both assessments.
Table 2.8 OLS regression of HOME total score at
six-months and eighteen months
| 6-MONTHS | 18-MONTHS |
beta | s.e. (beta) | standardised beta | sig | beta | s.e. (beta) | standardised beta | sig |
Group (intervention) | .315 | .442 | .032 | .477 | .823 | .480 | .079 | .088 |
Child's age at assessment (years) | -7.260 | 5.182 | -0.061 | .162 | -0.368 | 4.75 | -.035 | .438 |
Gender (male) | -0.986 | 0.416 | -0.104 | .018 | -0.484 | .470 | -.047 | .304 |
Mother's age (years) | 0.156 | 0.037 | 0.217 | <.001 | 0.222 | .039 | .287 | <.001 |
Ethnicity (minority ethnic) | -5.876 | 0.810 | -0.362 | <.001 | -6.203 | .842 | -.361 | <.001 |
Parity (first time mother) | 1.183 | 0.552 | 0.124 | .033 | 0.455 | .605 | .044 | .452 |
No partner | - | - | - | - | -2.153 | .709 | -.140 | .003 |
No maternal qualifications | - | - | - | - | -1.189 | .584 | -.095 | .043 |
Number of resident children | -0.573 | 0.236 | -0.134 | .016 | -1.075 | .263 | -.233 | <.001 |
Birthweight (ounces) | 0.040 | 0.011 | 0.168 | <.001 | 0.040 | .011 | .162 | .001 |
Baseline self-esteem | 0.104 | 0.049 | 0.097 | .033 | - | - | - | - |
Mother's self-control score | - | - | - | - | -0.162 | .063 | -.118 | .011 |
Higher income household | 1.485 | 0.510 | 0.150 | .004 | - | - | - | - |
Lower income household | -1.163 | 0.539 | -0.108 | .032 | -1.405 | .590 | -.118 | .018 |
NS-SEC class 6 or 7 | - | - | - | - | -1.344 | .544 | -.110 | .014 |
Research nurse A | 1.298 | 0.458 | 0.132 | .005 | - | - | - | - |
(Constant) | 27.97 | 3.322 | - | <.001 | 36.52 | 7.48 | - | <.001 |
N | 315 | | | | 274 | | | |
Adjusted R-squared | .42 | | | | .47 | | | |
This association was supported by the retention in the model
of number of cognate variables that express either
personal-disadvantage (no maternal qualifications) or
household-level material advantage/disadvantage (birthweight
and 'lower class' respectively). The models predict,
respectively, 42% and 47% of the total variation in HOME
scores.
Table 2.9 Logistic regression of EPDS
'caseness' (score is 13 or greater) at 6 and 18
months.
Predictor | 6 MONTHS | 18 MONTHS |
odds ratio | p | odds ratio | p |
Group (intervention) | 0.258 | .004 | 1.718 | .220 |
Gender (male) | 1.231 | .571 | 1.272 | .548 |
Mother's age (years) | 1.033 | .293 | 1.080 | .025 |
Ethnicity (minority ethnic) | 6.127 | .003 | 3.278 | .030 |
Parity (first time mother) | 0.723 | .416 | 1.540 | .338 |
Child spent time in SCBU | 4.058 | .003 | - | - |
Difficulty of child's behaviour | 2.388 | .024 | - | - |
Baseline self-esteem | 0.845 | <.001 | 0.907 | .045 |
Mother's self-control score | - | | 1.162 | .005 |
Previous mental health problems | 7.135 | <.001 | - | - |
Significant life-events in past year | - | - | 1.592 | <.001 |
Higher household income | 0.331 | .018 | - | - |
Number of home visits to 6 months | 1.116 | .022 | - | - |
Constant | 0.520 | .585 | 0.006 | .001 |
N = | 359 | | 276 | |
Table 2.9 shows the results of logistic regression modelling
with EPDS 'caseness' (the outcome expressing the proportion of
women scoring above the potentially clinically significant
threshold of 12/13). Minority ethnic women were more likely to
post high EPDS scores at both assessments as were women with
low levels of self-esteem. These variables, however, are the
only real instances of similarity in what are plausible but
quite distinct models. In contrast to the preceding section, a
substantial intervention effect emerged at six months: after
controlling for other relevant variables, mothers receiving the
'Starting Well' service were less likely to report high levels
of depressive symptoms than those receiving the generic
service. This advantage was not repeated at eighteen months
however, and even showed signs of reversal with intervention
women now
more likely to score above threshold. At six months,
mothers whose newborn had either spent time in intensive care
or who presented with difficult behaviour were more likely to
show depressive symptoms, as were women with a history of
mental health problems. This latter association with
vulnerability may also underlie the significant positive
association between caseness and number of home visits; health
visitors adjusted to a high score at routine assessment by
increasing the amount of contact. At eighteen months, a more
parsimonious model emerged with maternal age, low self-control
and the experience of significant life-events (bereavement,
pregnancy, job-loss, etc) predicting caseness.
Finally in this section, table 2.10 shows the results for
logistic regression with mother-reported dental registration
status. A statistically significant intervention effect was
observed at both six and eighteen months: more 'Starting Well'
mothers reported that they had registered their baby than those
receiving the generic service. This advantage was particularly
marked at six months. Few other similarities existed across
models, although indices of unemployment
28 predicted lower levels of registration at both
assessments.
Table 2.10 Logistic regression of dental
registration status ('yes') at six and eighteen
months.
Predictor | 6 MONTHS | 18 MONTHS |
odds ratio | p | odds ratio | p |
Group (intervention) | 2.742 | <.001 | 2.218 | .013 |
Gender (male) | 0.963 | .871 | 1.719 | .073 |
Mother's age (years) | 1.001 | .949 | 1.061 | .023 |
Ethnicity (minority ethnic) | 0.474 | .069 | 0.504 | .164 |
Parity (first-time mother) | 0.989 | .966 | 1.275 | .472 |
Child spend time in SCBU | 2.210 | .017 | - | - |
NS-SEC class 8 | 0.441 | .003 | - | - |
Workless household | - | - | 0.475 | .018 |
Constant | 0.379 | .141 | 0.447 | .353 |
N = | 359 | | 294 | |
2.3.3 User-satisfaction
The proportion of 'very satisfied' responses in each group
is shown in table 2.11. The table displays two additional
statistics: the proportion of all women at eighteen months who
reported the service was 'better than expected'; and the
proportion of multiparous mothers who reported their current
experience of health visiting was 'better then before'.
Table 2.11: descriptive statistics for measures
of user-satisfaction
| GROUP | difference | p
29 |
comparison | intervention |
% very satisfied with HV support |
At 6-months | 53.4 | 68.2 | 14.8 | .005 |
At 18-months | 37.3 | 56.4 | 19.1 | .002 |
% all women (n=294) reporting service was
'better than expected' at 18-months | 20.2 | 46.9 | 26.7 | <0.001 |
% multiparous mothers (n=174) reporting service
was 'better than before' at 18-months | 19.4 | 49 | 29.6 | <0.001 |
On the strength of these unadjusted comparisons, receiving
'Starting Well' is associated with higher perceived levels of
health-visitor support than generic health visiting and the
service exceeds expectations for a large proportion of women.
This intervention advantage is particularly strong for
multiparous women comparing current experiences of the service
to their last.
Table 2.12 confirms the finding for satisfaction with health
visitor support using logistic regression
30: a statistically significant intervention effect was
observed at six months which became more significant at
eighteen months. Considerable stability in levels of
satisfaction was shown by the fact the baseline measure
(collected at around 2-3 months postpartum) was a significant
predictor of later satisfaction. Positive attitudes towards
health visitors at baseline also predicted satisfaction at six
months, though whether these attitudes were pre-existing or had
already been changed by the time of the baseline assessment is
not clear. Finally, smoking during pregnancy positively
predicted satisfaction at both assessments although there is no
obvious
a priori reason for this to be the case.
Table 2.12 Logistic regression of satisfaction
with health visiting service ('very
satisfied')
Predictor | SIX MONTHS | EIGHTEEN MONTHS |
odds ratio | p | odds ratio | p |
Group (intervention) | 1.882 | .024 | 2.861 | .000 |
Gender (male) | 0.829 | .490 | 0.657 | .111 |
Mother's age (years) | 0.993 | .744 | 1.032 | .170 |
Ethnicity (minority ethnic) | 1.347 | .587 | 0.566 | .204 |
Parity (first time mother) | 0.655 | .176 | 0.904 | .734 |
Smoked in pregnancy (yes) | 1.974 | .021 | 2.280 | .006 |
Baseline satisfaction with HV | 5.425 | <0.001 | 2.447 | .002 |
Positive baseline attitudes to HVs | 1.190 | <0.001 | - | - |
Number of community facilities used | 0.607 | .003 | - | - |
Not car-owner | - | - | 0.559 | .042 |
Constant | 0.013 | <0.001 | 0.145 | .025 |
N = | 341 | | 273 | |
2.4 Discussion and conclusions
2.4.1 Evidence for intervention effects
After first establishing the basic representativeness of the
recruited sample and confirming the more intensive, home-based
nature of 'Starting Well', we assessed the evidence for
intervention effects on a range of health indicators over the
first eighteen months of the child's life. By standard
scientific criteria, the project was not successful in
improving the quality of the home environment relative to
generic health visiting, although the association was positive
at both assessments and approached levels of statistical
significance at eighteen months. A number of clearer
intervention effects were observed: more 'Starting Well'
children were registered with a dentist at six and eighteen
months; their mothers were more satisfied with levels of health
visitor support at both assessments and were also less likely
to be at risk of postnatal depression at six months. At face
value, these findings are undoubtedly encouraging and suggest
that diverse outcomes relating to the home environment,
psychological functioning, health-related behaviour and
service-related attitudes can be modified by an enhanced
home-visiting service over a relatively short period of time.
We will now briefly discuss each set of findings in turn.
HOME score
A recent and authoritative systematic review (including a
meta-analysis of twelve studies) concluded that there was
strong evidence for the positive effects of home visitation on
the quality of the home environment as indexed by the HOME and
related measures (Elkan et al, 2000; Bull et al, 2004). Given
this evidence-base, why did we not observe more clear
intervention effects? Three sets of points are relevant: basic
problems of comparability with other studies; the possible
dilution of effects due to service heterogeneity; and
statistical power considerations. Taking the comparability
point first, Elkan and colleagues' work is unquestionably
rigorous but their conclusions are based largely on North
American randomised control trials of diverse interventions
delivered to particular high-risk groups, often in the absence
of routine health visiting. Variation also exists in the timing
of HOME assessments and the exact measure used. Moreover, only
seven out of seventeen studies reviewed provided positive and
statistically verifiable evidence of intervention effects
31. Given these basic problems of comparability and the
equivocacy of the literature in general, it may be concluded
that expectations of very marked intervention effects were
unrealistic. Secondly, the intervention itself developed
rapidly over time and introduced new components (e.g. the
'skill mix' of auxiliary health professionals and
paraprofessionals) more than halfway through its initial phase.
Given that participants were recruited over a thirteen month
period, it may well be that later recruits were receiving a
qualitatively different service to earlier recruits. If true,
but not well-captured in analysis, this service variation may
serve to dilute intervention effects. Finally, our ability to
detect group effects may have been further compromised by the
decision to use smaller, 'richer' datasets for regression
analysis which may have unfavourably traded power (in terms of
number of cases) for comprehensiveness (in terms of the range
of available predictors).
Given the above limitations, it is perhaps all the more
notable that we observed a 'borderline' intervention effect
(p=0.088) at eighteen months. Whilst we do not suggest a
shifting of the 'statistical goalposts' to accommodate this
finding, borderline results are a feature of the HOME
literature
32. Given both the complexity of the project and the
limitations of evaluation, it is probably wise to avoid a
simple success/failure conclusion based solely on significance
level (Sterne and Davey-Smith, 2001) and tentatively explore
the possibility that our findings point to a cumulative and/or
delayed impact of the intervention on home environment. If this
is true, and the small relative advantage continues to grow
beyond eighteen months, the well-described associations of
quality of early stimulation to later cognitive and behavioural
development (Bradley, 1993; Shonkoff and Phillips, 2000) might
suggest real future advantages for 'Starting Well'
children.
Postnatal depression
Results at six-months postpartum support a number of studies
showing the positive impact of home-based interventions
delivered by trained health visitors (Holden, Sagovsky and Cox,
1989; Gerrard, Holden, Elliot, et al, 1993; Seeley, Murray and
Cooper, 1996; Cooper and Murray, 1997). In this study, the fact
that an intervention effect emerged despite the cohorts having
an apparently identical proportion of 'at-risk' women
underlines the importance of including relevant statistical
controls in analysis; there were fewer 'at risk' women in the
intervention group than would be predicted from their
background characteristics. Findings at eighteen months are
harder to interpret. Original work by the primary developer of
the EPDS (Cox, 1986) suggested that postnatal depression either
occurred in the first few months after birth or not at all. At
eighteen months then, it is doubtful whether one can talk
meaningfully of women having postnatal depression but the
instrument may still have some validity as an indicator of
depressive symptoms. If this is true, it is clear that the
early mental health benefits afforded to 'Starting Well'
mothers fade over time, with prevalence 'returning' to levels
predicted by other key sample characteristics (e.g.
deprivation) at eighteen months.
Taking the six-month finding in isolation, the evidence-base
linking postnatal mood disorders to impaired child cognitive
and emotional development (Murray, 1992; Murray, Fiori-Cowley,
Hooper and Cooper, 1996) strongly suggest that 'Starting Well'
could deliver immediate benefits to the depressed mother and
more enduring benefits to the child. This may be particularly
salient for this socio-economically disadvantaged cohort as
children of poor depressed mothers are at substantially greater
risk of impaired development (Murray & Cooper, 1997). Two
qualifying points may be made, however. First, developmental
impairment is more strongly predicted by disturbed maternal
interactional style than by simple exposure to depressed mood;
at this stage, however, we have only demonstrated an
intervention effect in relation to reduced exposure. A
pertinent question might then be 'was there an intervention
effect on the interactional style (indexed for example by HOME
Inventory sub-items) of depressed mothers?' Unfortunately, both
the relatively small absolute numbers of EPDS high-scorers and
the fact that only cross-sectional analyses are possible on
six-month data
33 mean that we are poorly equipped to test this hypothesis.
Second, the practical, service-development implications of the
positive six-month result are not straightforward as is it not
clear what aspect(s) of the intervention produced the observed
effect. Most intervention studies focus exclusively on
postnatal depression and involve dedicated training in
non-directive counselling techniques whereas 'Starting Well'
has a much broader health focus and improved maternal mood
without comparable training. At this stage then, findings are
only supportive of a 'whole package' effect of the intervention
on depressive symptoms but one candidate for the 'active'
ingredient may be the quality of the mother-health visitor
contacts (Korfmacher, Kitzman and Olds, 1998; Elkan et al, 2000
). This point will be pursued in later sections.
Finally, it is clear from our longitudinal findings that
women who have previously scored below threshold at six months,
can go on to score highly at eighteen months. These families
may constitute an important vulnerable group who would not
ordinarily be identified as 'at risk' from earlier assessments
34.
Satisfaction with health visitor support
Very few evaluations of health-visiting interventions make
explicit efforts to assess client-satisfaction and those that
do use methods that are notably inconsistent (Elkan et al,
2000; Bull et al, 2004). This may be due to a widespread
perception that survey responses are meaningless when the
overwhelming majority of respondents express general
satisfaction with all health services due to the desire to give
a socially-acceptable response (Avis, Bond and Arthur, 1995).
Whilst it is true that the vast majority of participants in
this study were either 'very' or 'fairly' satisfied with levels
of health visitor support, responses were submitted via a
confidential postal questionnaire and to a researcher as
opposed to a health practitioner. In these perhaps less-biased
circumstances, the distinction between the two terms (the
former emphatic, the latter 'lukewarm') may be more valid and
when the size of the group differences are considered,
alongside those for the other measures expressed in table 2.11,
it may be concluded that a clear preference is being expressed
for the enhanced service. It is notable too, that contrary to
other studies that show client satisfaction diminishing over
time (Graham, 1979), our findings show that it actually
strengthened from six to eighteen months.
Dental registration
Scottish child dental health statistics are stark: only
one-third of children aged 0-2 are registered with a dentist
(Information and Statistics Division, NHS Scotland, 2003) and
by age five, 55% of children have dental disease (Scottish
Executive, 2003). Marked social gradients are observed for both
registration and outcomes (Davies, 1999). Against this
backdrop, we have demonstrated strong evidence of project
impact on dental registration rates over the first eighteen
months of life. It is clear, however, that the substantive
implications of this finding depend crucially on the extent to
which registration is translated into actual attendance and/or
better dental health (for example, fewer dental caries or tooth
loss). Whilst positive cross-sectional associations between
children's' dental registration status and dental health have
been demonstrated (Pitts, 1995), the causal nature of this
relationship remains unclear. Conclusions from this study
should, therefore, be guarded until comparative practice data
can be collected
35.
2.4.2 Associations between outcomes and other
predictors
Two sets of variables especially merit further comment:
material (dis)advantage and ethnicity.
Material (dis)advantage
The last two decades have witnessed an explosion of
multi-disciplinary research into health inequalities and their
relationship to income and social status. Our findings support
this literature in two ways. Firstly, both cohorts are
disadvantaged in terms of their
absolute material resources and display
correspondingly high levels of adverse health and other
behaviour (e.g. maternal smoking). Secondly, families'
relative position within this cohort, in terms of
available material resources, is robustly and consistently
associated with each outcome. These findings, whilst
unsurprising, point to the relatively limited potential of
health services to impact on the health of deprived populations
when unaccompanied by improved material circumstances and
firmly point to the need to link vulnerable low-income families
to both local and national poverty-reduction initiatives.
Ethnicity
Minority ethnic status was strongly associated with lower
HOME scores, higher EPDS scores and lower rates of dental
registration and, at face value, these findings offer a
comparatively poor prognosis for these children. It is likely,
however, that systematic measurement error is responsible for
at least some of this apparent difference in outcome. The HOME,
though used internationally in a variety of cultural settings,
has never been validated on a
British Asian cohort and the authors of the instrument
admit that additional work is necessary in order to establish
its wider validity (Bradley, 1993
). Similarly, there are well-recognised problems with
the translation of concepts relating to depression (Launguni,
1997; 2000) and with the EPDS in particular (Elliott, 1996;
Gerrard, 2000). Measurement error is, perhaps, a less
convincing explanation of lower dental registration rates; not
only is this item a much simpler concept constructed from a
response to a single survey item, the finding also supports
other studies of infant feeding and dental health amongst
British Asian populations (see Watt, 2000).
In summary, the findings most probably reflect both
measurement issues and real health-relevant cultural
differences and illustrate the need for culturally sensitive
assessment tools and culturally-competent health workers of the
type being piloted in 'Starting Well'.
2.4.3 Next steps
A number of points may be made regarding instrumentation and
measures. Firstly, our use of the number of home visits by
health visitors is a useful but limited measure of service
input that tends to understate the amount of contact (e.g.,
from health support workers) in the intervention group. More
sensitive and comparable indicators are required, including
perhaps, contacts with health staff that are not recorded by
the index health visitor. It would also be advantageous to
develop an equivalised measure of input that ascribed different
weightings to different types of contact. This would mean, for
example, that a ninety-minute face-to-face home visit from a
health visitor is accorded considerably more importance than a
five-minute phone contact from a lay worker. Secondly, more
work is required on research nurse inter-rater reliability in
order to account for the observed investigator effect on HOME
score. Thirdly, the cultural specificity of both the HOME and
EPDS necessitates careful interpretation of results, and may
benefit from separate analyses, although numbers are small.
These and other points will be pursued in further analysis in
due course.
Finally, we have, by necessity, focussed on a narrow range
of indirect/intermediary outcomes. In order to demonstrate a
'step-change' in child health, we would need to show that
Starting Well had a
direct influence on
actual child-centred outcomes such as school readiness
or cognitive development. Whether or not this will be possible
with the existing cohort remains to be seen, but we are
optimistic. We have made strenuous efforts to put in place
mechanisms for retaining contact with existing respondents and
to maximise the availability of essential baseline information.
Our current assumption is that by the beginning of 2005, when
the first of the study children will be 42 months old, we might
reasonably expect to be able to contact approximately 500
families and that about 70 per cent of these (N=350) would
respond positively to a further round of data collection. On
this basis there is a strong case to be made for further
follow-up.
2.4.4 Conclusions
In conception, the project was influenced by both a general
(review-based) and specific (Olds and colleagues) evidence-base
that suggested a home-visiting service with key characteristics
could result in demonstrable improvements in
child-health-relevant outcomes. The exact correspondence of the
project plan to this evidence-base and the fidelity with which
it was carried out are important empirical questions. Basic
problems in transferring findings from the north American to
British contexts, however, cast doubt on the extent to which
marked
expectations of impact were realistic. In addition,
methodological problems associated variously with project-area
size, short recruitment and assessment timescales, imperfect
participation, and attrition, have limited both the range of
outcomes used and the number of participants available for
analysis. All of these factors have limited the capacity of
this evaluation component to
detect impact.
Despite these impediments, we have recruited a not-obviously
biased sample of families and uncovered evidence that is
suggestive of project impact on earlier maternal psychological
health and later quality of the home environment. When
considered alongside findings relating to client-satisfaction,
we can begin to build a picture of a service that is delivering
generally higher levels of support than generic health
visiting. In doing so, it may have the potential to impact on
families in ways that are not only beneficial to the mother in
the short-term but may also have more enduring benefits for the
child.
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