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ORIGINAL ARTICLE
Improving infant sleep and maternal mental health: a cluster
randomised trial
Harriet Hiscock, Jordana Bayer, Lisa Gold, Anne Hampton, Obioha C Ukoumunne, Melissa Wake
...................................................................................................................................
See end of article for
authors’ affiliations
........................
Correspondence to:
Dr Harriet Hiscock, Centre
for Community Child Health,
Royal Children’s Hospital,
Flemington Road, Parkville,
VIC 3052, Australia;
harriet.hiscock@rch.org.au
Accepted 22 November
2006
Published Online First
6 December 2006
........................
Arch Dis Child 2007;92:952–958. doi: 10.1136/adc.2006.099812
Objectives: To determine whether a community-delivered intervention targeting infant sleep problems
improves infant sleep and maternal well-being and to report the costs of this approach to the healthcare
system.
Design: Cluster randomised trial.
Setting: 49 Maternal and Child Health (MCH) centres (clusters) in Melbourne, Australia.
Participants: 328 mothers reporting an infant sleep problem at 7 months recruited during October–
November 2003.
Intervention: Behavioural strategies delivered over individual structured MCH consultations versus usual care.
Main outcome measures: Maternal report of infant sleep problem, depression symptoms (Edinburgh
Postnatal Depression Scale (EPDS)), and SF-12 mental and physical health scores when infants were 10 and
12 months old. Costs included MCH sleep consultations, other healthcare services and intervention costs.
Results: Prevalence of infant sleep problems was lower in the intervention than control group at 10 months
(56% vs 68%; adjusted OR 0.58 (95% CI: 0.36 to 0.94)) and 12 months (39% vs 55%; adjusted OR 0.50
(0.31 to 0.80)). EPDS scores indicated less depression at 10 months (adjusted mean difference 21.4 (22.3
to 20.4) and 12 months (21.7 (22.6 to 20.7)). SF-12 mental health scores indicated better health at
10 months (adjusted mean difference 3.7 (1.5 to 5.8)) and 12 months (3.9 (1.8 to 6.1)). Total mean costs
including intervention design, delivery and use of non-MCH nurse services were £96.93 and £116.79 per
intervention and control family, respectively.
Conclusions: Implementing this sleep intervention may lead to health gains for infants and mothers and
resource savings for the healthcare system.
Trial registration: Current Controlled Trial Registry, number ISRCTN48752250 (registered November 2004).
M
aternal depression impacts adversely on maternal
quality of life, mother–child relationships and child
development.
12
Despite a prevalence of 15% in the first
year postpartum,
3
depression often remains undiagnosed and,
even if detected, many mothers reject the diagnosis, the
treatment or both.
4
Maternal depression is linked to poor infant sleep. Problems
with frequent night waking and difficulties settling to sleep are
reported by over a third of parents in the second 6 months of
life
56
and are consistently associated with poor maternal
health.
7–9
In a previous efficacy trial, we demonstrated that treating
infant sleep problems (simple behavioural techniques delivered
in local well-child centres over two to three sessions)
significantly reduced maternal reports of depression symptoms
as well as infant sleep problems.
10
However, efficacy and
generalisability may be limited by the predominantly middle-
class status of participating families and the fact that the
intervention was delivered by a single paediatrician (HH). In
another randomised trial,
11
a single, nurse-led consultation
emphasising ways to help very young infants settle to sleep
independently resulted in intervention infants sleeping more
than controls at age 12 weeks but in no change in maternal
depression. All other sleep intervention trials have been limited
by selection bias, small sample sizes, short follow-up and/or
lack of randomisation.
12
The trial reported here was conducted within an existing
universally available, state-wide primary health care service,
training the well-child care providers themselves to manage
infant sleep problems in families from a broad sociodemo-
graphic sample. We hypothesised that a brief behavioural
intervention designed to reduce infant sleep problems would
result in improved infant sleep and maternal well-being. We
also documented the costs of the intervention and costs to the
healthcare system.
METHODS
The trial was conducted in greater Melbourne (population 3.4
million), Victoria, Australia. Melbourne has 31 local govern-
ment areas (LGAs), each with around 750 births per annum.
LGAs were ranked by the census-derived Socio-Economic
Indexes For Areas (SEIFA) Index of Relative Disadvantage
(Australian Bureau of Statistics, 2001), and thence divided into
tertiles representing low, middle and high socioeconomic
status. From each tertile, two LGAs were selected; all
Maternal and Child Health (MCH) nurses in these six LGAs
participated.
Every infant born in the state of Victoria is assigned a MCH
nurse, and 91% of parents attend the free health visit offered at
4 months of age.
13
MCH nurses consecutively invited mothers
of 4-month-old infants attending in October–November 2003 to
take part in the Infant Sleep Study. Infants born before
32 weeks’ gestation and mothers with insufficient English to
complete questionnaires were excluded. The research team
telephoned interested mothers and mailed the baseline ques-
tionnaire to be returned with written informed consent.
Abbreviations: EPDS, Edinburgh Postnatal Depression Scale; GEE,
generalised estimating equations; ICC, intraclass correlation coefficient;
IQR, interquartile range; LGA, local government area; MCH, Maternal and
Child Health; SEIFA, Socio-Economic Indexes For Areas
952
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Randomisation
When infants turned 7 months, MCH centres (and therefore
their mothers) were randomly allocated (stratifying by LGA) to
intervention or control arms by an independent statistician (fig
1). Centres were ranked within each stratum according to the
number of infants recruited at 4 months, randomising the
largest centre and alternately allocating subsequent ones to
avoid a marked imbalance in cluster sizes between trial arms.
As all the centres were recruited prior to randomisation and
ranked using a criterion that could not be influenced by the
investigators, allocation concealment was achieved. Mothers
reporting an infant sleep problem in the concurrent 7-month
questionnaire comprised the study sample.
Intervention
Intervention nurses attended two 2.5 h training sessions
conducted by HH (paediatrician) and JB (child psychologist).
Training incorporated didactic teaching, written information,
role play and trouble shooting common problems (eg, partner
conflict over sleep management).
Intervention mothers were advised by letter that their MCH
nurse was trained to provide advice to help manage their
infant’s sleep. At the first consultation (8-month well-child
visit) nurses elicited the nature of the sleep problem, identified
solutions, and wrote an individualised sleep management plan
with the mother. Two handouts discussed normal sleep
patterns at 6–12 months and sleep associations and their
causal role in sleep problems. Handouts on managing problem
overnight feeding (ie, reducing volume/time spent feeding over
a week) and dummies (ie, removal or teaching infant to replace
own dummy) were also available.
Mothers were offered the choice of two behavioural inter-
ventions: i) ‘‘controlled crying’’ whereby parents respond to
their infant’s cry at increasing time intervals, to allow
independent settling
14 15
or ii) ‘‘camping out’’, ie, sitting with
their infant until they fell asleep and gradually removing
Table 1 The 10- and 12-month outcome results by randomisation group
Outcome
Group Adjusted comparative statistic (intervention relative to control)
Intervention Control Statistic (95% CI) p Value ICC
10 months
Sleep problem, n (%) 92 (56) 100 (68) 0.58 (0.36, 0.94) 0.03 0
Global Infant Temperament score, mean (SD) 2.7 (0.9) 2.9 (0.9) 20.1 (20.3, 0.1) 0.31 0.028
EPDS score .9, n (%) 46 (28) 51 (35) 0.63 (0.35, 1.12) 0.11 0
Total EPDS score at 2 months, mean (SD) 6.8 (5.1) 7.8 (5.5) 21.4 (22.3, 20.4) 0.007 0
Poor/fairly poor sleep quality, n (%) 102 (63) 104 (72) 0.69 (0.41, 1.15) 0.16 0
Not enough/not nearly enough sleep, n (%) 64 (40) 66 (46) 0.76 (0.46, 1.24) 0.27 0.009
SF12 – physical health, mean (SD) 51.6 (7.3) 51.5 (7.6) 0.2 (2 1.6, 2.0) 0.83 0.017
SF12 – mental health, mean (SD) 48.1 (10.3) 45.0 (11.0) 3.7 (1.5, 5.8) 0.001 0
12 months
Sleep problem, n (%) 64 (39) 80 (55) 0.50 (0.31, 0.80) 0.004 0
Global Infant Temperament score, mean (SD) 2.7 (0.9) 2.9 (0.9) 20.2 (20.4, 0.0) 0.07 0
EPDS score .9, n (%) 41 (25) 41 (28) 0.71 (0.39, 1.30) 0.26 0
Total EPDS score, mean (SD) 5.9 (4.8) 7.2 (5.2) 21.7 (22.6, 20.7) 0.001 0
Poor/fairly poor sleep quality, n (%) 83 (52) 92 (63) 0.52 (0.32, 0.86) 0.01 0
Not enough/not nearly enough sleep, n (%) 55 (34) 65 (45) 0.55 (0.33, 0.92) 0.02 0
SF12 – physical health, mean (SD) 50.8 (7.2) 52.7 (6.7) 21.7 (23.3, 20.1) 0.04 0
SF12 – mental health, mean (SD) 49.7 (9.2) 46.1 (10.7) 3.9 (1.8, 6.1) ,0.001 0.001
The comparative statistic is mean difference for quantitative outcomes and odds ratio for dichotomous outcomes.
Sample size ranged from 148 to 159 in the intervention arm and 138 to 144 in the control arm at 10 months and ranged from 145 to 154 in the intervention arm and
134 to 139 in the control arm at 12 months. Analyses adjusted for whether the mother received paid professional help for the infant’s sleep problem at the time of follow-
up and perceived nurse competency. Analysis of sleep problem was additionally adjusted for Socio-Economic Indexes For Areas (SEIFA) Index of Relative Disadvantage
code and mother’s educational level. Analyses of maternal EPDS score, sleep quality, sleep quantity, and SF12 physical and health scores were additionally adjusted for
baseline EPDS total score. Analyses of Global Infant Temperament score were additionally adjusted for baseline EPDS total score and Global Infant Temperament at
baseline. EPDS, Edinburgh Postnatal Depression Scale.
Negative estimates of the intraclass correlation coefficient (ICC) are truncated at zero.
Table 2 Test of EPDS score at baseline as a modifier of the intervention effect on percentage with sleep problems and mean EPDS
scores by randomisation group
Outcome
EPDS
baseline
score
Group Adjusted comparative
statistic (intervention
relative to control)
p Value for
interactionIntervention n Control n
Sleep
Sleep problem at 10 months, n (%) .9 34 (54) 63 43 (72) 60 0.34 (0.14, 0.81) 0.24
(9 58 (58) 100 57 (66) 87 0.71 (0.38, 1.32)
Sleep problem at 12 months, n (%) .9 30 (47) 64 36 (62) 58 0.49 (0.22, 1.07) 0.88
(9 34 (34) 99 44 (50) 88 0.48 (0.26, 0.90)
EPDS score
Total EPDS score at 10 months, mean (SD) .9 9.5 (5.6) 63 11.8 (5.0) 60 22.1 (23.9, 20.2) 0.05
(9 5.1 (4.0) 100 5.1 (4.1) 87 20.2 (21.4, 0.9)
Total EPDS score at 12 months, mean (SD) .9 8.9 (4.8) 64 10.5 (4.6) 58 21.6 (23.2, 0.1) 0.56
(9 4.0 (3.8) 99 5.0 (4.3) 88 21.3 (22.6, 0.1)
The comparative statistic is odds ratio for sleep problem and mean difference for EPDS score. EPDS, Edinburgh Postnatal Depression Scale.
All analyses adjusted for whether a mother received paid professional help for the infant’s sleep problem and level of nurse competency. The test of interaction for the
sleep problem outcome was additionally adjusted for Socio-Economic Indexes For Areas (SEIFA) Index of Relative Disadvantage code and mother’s education.
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parental presence over 3 weeks. Mothers maintained daily sleep
diaries until the follow-up appointment 2 weeks later, to
facilitate recognition of sleep patterns and improvements and
to help set further goals.
Measures
Mothers completed written questionnaires at 4 months (socio-
demographic details), 7 months (prior to randomisation, to
establish the presence of a sleep problem), and at 10 and
12 months (to measure outcomes). The primary outcome was
maternal report of infant sleep (‘‘Over the last 2 weeks, has
your baby’s sleep generally been a problem for you?’’ Yes/No),
an established indicator of frequent and prolonged night
wakings.
6
Maternal well-being was a secondary outcome,
measured by the 10-item Edinburgh Postnatal Depression
Scale (EPDS)
16
(community cut-point for depression is a score
.9
17
) and the SF-12,
18
a 12-item, validated, measure of physical
and mental health with higher scores indicating better health.
Other validated outcome measures were maternal sleep quality
and quantity (using a 4-point ordinal question,
19
and dichot-
omised at the midpoint into good versus bad quality and
enough versus not enough quantity), and maternal rating of
infant temperament (5-point Global Infant Temperament
Scale
20
higher scores indicate a more difficult baby). Mothers
also rated their confidence in their nurse’s health advice, on a
4-point, ordinal, study-designed scale. Intervention mothers’
reported satisfaction with and usefulness of the sleep informa-
tion in treating their infant’s sleep problem, on 10-cm visual
analogue scales.
6
They reported how often they used the
strategies (from ‘‘none of the time’’ to ‘‘all of the time’’) and
degree of support they received from their partner when using
the sleep strategies (4-point scale ranging from ‘‘hardly ever
supported me’’ to ‘‘supported me almost all the time’’). All
mothers were asked if they had received help other than that
given in the study and, if so, from where (eg, stay at a parenting
centre). In the 12-month questionnaire, intervention mothers
also rated specific advice/strategies given by their nurse as
‘‘helpful’’ or ‘‘unhelpful’’.
Costs
At 10 and 12 months, mothers reported on the number of MCH
visits for sleep advice and non-MCH nurse professional health
care (eg, parenting centres, family doctor) and non-professional
care (eg, books, relatives). Nurses provided information on
number and duration of sleep visits for mothers in the
intervention group. The cost of intervention materials (design
and production) and nurse training programme (design and
delivery) was calculated from research budgets, with total cost
allocated equally over all intervention group mothers.
Nurse visits, outreach visits and telephone support costs were
calculated using average MCH nurse salary data. Admissions to
a parenting centre were valued using cost estimates from two of
eight Melbourne centres. Other health service use costs were
calculated using Medicare Benefits Schedule fees.
21
Project approval was obtained from the Ethics in Human
Research Committee of Melbourne’s Royal Children’s Hospital
(23067B). The trial was conducted in accordance with the
CONSORT statement for cluster randomised trials.
22
Sample size
To detect a difference of 20% (70% in the control group and 50%
in the intervention group) in the primary outcome, an
individually randomised trial would require 103 infants in
each arm to have 80% power at the 5% level of significance. This
sample size was inflated by a design effect of 1.2 to 124 infants
per trial arm to allow for correlation between responses within
the same cluster (ie, MCH centre),
23
with an expected average
Table 3 Sample characteristics by randomisation group at
baseline (7 months)*
Variable
Randomisation
Control
(n = 154)
Intervention
(n = 174)
Infant
Infant age, mean (SD) 7.3 (0.6) 7.4 (0.6)
Male, n (%) 89 (58) 89 (51)
Birth weight (g), mean (SD) 3432 (488) 3461 (507)
Family position, n (%)
First 72 (47) 83 (48)
Second 55 (36) 54 (31)
Third or more 25 (16) 37 (21)
Exclusively breast feeding (at 93 (60) 104 (60)
4 months), n (%)
Difficult temperament, n (%) 44 (29) 40 (23)
Infant sleep
Sleep problem severity, n (%)
Mild 37 (24) 38 (22)
Moderate 58 (38) 66 (38)
Severe 59 (38) 70 (40)
Number of waking nights/week
Median (IQR) 7 (5–7) 7 (5–7)
0–3, n (%) 22 (14) 28 (16)
4–6, n (%) 44 (29) 46 (26)
7, n (%) 88 (57) 100 (57)
Who responds to waking infant
overnight?
Mother, n (%) 135 (91) 155 (90)
Father, n (%) 6 (4) 3 (2)
Both parents, n (%) 8 (5) 15 (9)
Sleep site, n (%)
Cot in own/sibling’s room 101 (66) 122 (71)
Parent’s room 36 (24) 30 (17)
Parent’s bed 16 (10) 20 (12)
Family
Maternal age (years), mean (SD) 33.2 (4.8) 32.8 (4.3)
Relationship status, n (%)
Married/de facto 145 (97) 172 (99)
Parents’ country of birth
(mother’s/father’s), n (%)
Australia or New Zealand 124 (81)/ 139 (80)/
124 (82) 137 (79)
Language other than English 31 (20) 32 (18)
at home, n (%)
Education status (mother’s/
father’s), n (%)
Did not complete high school 28 (18)/43 (28) 29 (17)/49 (29)
Completed high school only 51 (33)/44 (29) 53 (30)/45 (26)
Completed tertiary/ 75 (49)/66 (43) 92 (53)/77 (45)
postgraduate degree
Socioeconomic status (SEIFA
ranking), n (%)
Low 35 (23) 24 (14)
Medium 41 (27) 63 (36)
High 78 (51) 87 (50)
Maternal health
Past history of depression, n (%) 32 (21) 36 (21)
EPDS
Mean (SD) 8.4 (5.1) 8.4 (5.3)
Median (IQR) 8 (4–12) 8 (4–12)
.9 (n (%)) 64 (42) 66 (38)
Maternal sleep, n (%)
Quality
Fairly/very good 74 (48) 77 (44)
Very/fairly bad 80 (52) 97 (56)
Quantity
Enough/more than enough 19 (12) 34 (20)
Not nearly/not quite enough 135 (88) 140 (80)
MCH centres, n
MCH centre clusters 24 25
Nurses 31 38
Families 154 174
Nurses per MCH centre cluster
Mean (SD) 1.35 (0.49) 1.52 (0.65)
Range 1–2 1–3
*Sample size ranged from 299 to 328.
EPDS, Edinburgh Postnatal Depression Scale; IQR, interquartile range;
MCH, Maternal and Child Health.
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cluster size of 11 (ie, number of eligible mothers attending the
centre) and intraclass correlation coefficient (ICC) of 0.02.
Analysis
Analyses were conducted on an ‘‘intention to treat’’ basis.
Outcomes and costs were compared between the intervention
and control groups at 10 and 12 months, adjusted for potential
confounders identified in our previous research
610
and deter-
mined a priori (see tables 1 and 2). Tests of interaction assessed
whether the impact of the intervention on the sleep problem
and the quantitative EPDS outcome was greater amongst
mothers with high baseline depression scores (EPDS.9) than
mothers with low scores.
To allow for clustering, quantitative outcomes and costs were
analysed using random effects linear regression
24
and dichot-
omous outcomes were analysed using logistic regression by
fitting marginal models using generalised estimating equations
(GEE) with ‘‘robust’’ estimates of standard error
25
and a
specified exchangeable correlation matrix. For GEE analyses
where the ICC was negative, the results from standard logistic
regression are reported. All quantitative outcomes and costs
(except the Global Infant Temperament score) were skewed
and, therefore, results were validated by non-parametric
bootstrapping.
26
Bootstrap confidence intervals were similar to
the confidence intervals from the main analyses, so the latter
are reported. Analyses were conducted using Stata 8 (Stata,
College Station, TX).
RESULTS
Response rates were 739 of 1025 eligible mothers at 4 months
(72%) and 695 (68%) at 7 months, of whom 328 reported a
problem with their infant’s sleep and were therefore partici-
pants in the trial. Intervention (n = 174) and control mothers
(n = 154) had similar infant, sleep, maternal and sociodemo-
graphic characteristics (table 3). Most mothers (84%) reported
insufficient sleep which was of poor quality (55%).
Infant sleep
At 10 months, 56% of intervention and 68% of control mothers
reported infant sleep problems (OR 0.61, p = 0.04); at 12 months,
this fell to 39% vs 55% (OR 0.53, p = 0.007). Thus to resolve one
infant sleep problem, 8.3 infants would be need to be treated at
10 months and 6.3 infants at 12 months. After adjusting for
potential confounders (table 1), the odds of reporting a sleep
problem in the intervention group were 42% lower at 10 months
and 50% lower at 12 months compared with controls.
Maternal well-being
At 10 months (table 1), 28% of intervention mothers and 35%
of control mothers scored .9 on the EPDS, indicating clinically
significant depression (adjusted OR 0.63, p = 0.11); comparable
figures at 12 months were 25% vs 28% (adjusted OR 0.71,
p = 0.26). Intervention mothers had lower mean EPDS scores
than controls at both 10 months (6.8 vs 7.8, adjusted mean
difference 21.4, p = 0.007) and 12 months (5.9 vs 7.2, adjusted
Table 4 Intervention mothers’ ratings of specific intervention components (n (%))*
Intervention Helpful Unhelpful Did not receive/do thisÀ
Information about normal sleep patterns in 6–12-month-old infants 43 (70) 6 (10) 12 (20)
Having someone to talk to 56 (93) 3 (5) 1 (2)
Filling out a sleep diary for the child 36 (59) 9 (15) 16 (26)
Learning what thing(s) made the child’s sleep problem better/worse 46 (79) 4 (7) 8 (14)
Having sleep cycles (ie, ‘‘heavy’’ and ‘‘light’’ sleep) explained 36 (60) 13 (22) 11 (18)
Information about managing dummies 17 (30) 10 (17) 30 (53)
Information about managing night feeds 24 (42) 8 (14) 25 (44)
Using ‘‘controlled crying’’ 47 (78) 9 (15) 4 (7)
Using ‘‘camping out’’ in a chair or bed 10 (17) 11 (18) 39 (65)
Putting child to bed awake 47 (78) 9 (15) 4 (7)
Advice on how to look after own well-being (eg, rest once a day) 24 (40) 6 (10) 30 (50)
*Sample size of intervention mothers who reported that they had received the information/strategies ranged from 57 to 61.
Not all mothers received or used each strategy as sleep management was tailored to specific needs.
Table 5 Number and percentage of mothers who accessed sources of help and advice (other than MCH nurse service)
8–10 months 10–12 months
Intervention, n = 163 Control, n = 147 Intervention, n = 163 Control, n = 146
Professional, n (%)
Parenting centre: day 4 (2.5) 7 (4.8) 3 (1.8) 4 (2.7)
Parenting centre: overnight 4 (2.5) 11 (7.5) 3 (1.8) 4 (2.7)
Telephone support 2 (1.2) 3 (2.0) 5 (3.1) 5 (3.4)
Nurse visit 0 (0) 3 (2.0) 1 (0.6) 5 (3.4)
Family doctor 6 (3.7) 9 (6.1) 5 (3.1) 7 (4.8)
Paediatrician 2 (1.2) 3 (2.0) 1 (0.6) 3 (2.1)
Chiropractor/osteopath 3 (1.8) 5 (3.4) 2 (1.2) 3 (2.1)
All professional sources, n (%)* 14 (8.6) 31 (21.1) 18 (11.0) 26 (17.8)
Non-professional, n (%)
Mother (in-law) 25 (15.3) 15 (10.2) 17 (10.4) 13 (8.9)
Friends/parent group 39 (23.9) 35 (23.8) 31 (19.0) 22 (15.1)
Written information/video 20 (12.3) 20 (13.6) 12 (7.4) 11 (7.5)
All non-professional sources`,1 48 (29.4) 43 (29.3) 35 (21.5) 26 (17.8)
All non-professional/professional sources** 54 (33.1) 64 (43.5) 46 (28.2) 39 (26.7)
*Odds ratio (95% CI) 0.37 (0.17 to 0.80), p = 0.01 at 8–10 months; odds ratio (95% CI) 0.55 (0.30 to 0.98), p = 0.04 at 10–12 months; `odds ratio (95% CI) 1.01
(0.62 to 1.63), p = 0.98 at 8–10 months; 1odds ratio (95% CI) 1.18 (0.75 to 1.86), p = 0.47 at 10–12 months; odds ratio (95% CI) 0.65 (0.40 to 1.05), p = 0.08 at 8–
10 months; **odds ratio (95% CI) 1.04 (0.66 to 1.64), p = 0.88 at 10–12 months.
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mean difference 21.7, p = 0.001) and higher mental health
(SF-12) scores at both 10 months (48.1 vs 45.0, p = 0.001) and
12 months (49.7 vs 46.1, p,0.001). Physical health was similar
at 10 months but unexpectedly poorer in intervention mothers
at 12 months (mean score 50.8 vs 52.7, adjusted mean
difference 21.7, p = 0.04).
Fewer intervention than control mothers reported poor sleep
quality at 10 months (63% vs 72%, adjusted p = 0.16) and
12 months (52% vs 63%, adjusted p = 0.01), and insufficient
sleep at 10 months (40% vs 46%, adjusted p = 0.27) and
12 months (34% vs 45%, adjusted p = 0.02).
In subgroup analyses (table 2), the effect of the intervention
on depression symptoms at 10 months was greater for mothers
whose initial EPDS score was .9.
Usefulness of sleep strategies
Table 4 shows the strategies intervention mothers found
helpful. Mothers were generally satisfied with the intervention
strategies (median 7.7, interquartile range (IQR) 5.5–9.2) and
found them useful (median 7.3, IQR 3.0–9.1). The majority
(56%) used the sleep strategies ‘‘most’’ to ‘‘almost all of the
time’’; only 7% reported no use. Most mothers (80%) reported
partner support with sleep strategies.
Costs
Mean costs for the intervention versus control group were
£96.93 (SD 249.37) versus £116.79 (SD 330.31), respectively
(mean difference 2£19.44 (95% CI 283.70 to 44.81), p = 0.55).
In the intervention group 100 mothers attended their nurse to
discuss infant sleep for an average of 1.52 visits, while in the
control group 30 mothers attended for an average of 1.32 visits.
Across all mothers, this gives an average reported use of nurse
sleep-related visits of 0.9 and 0.3 for intervention versus control
mothers, respectively. The mean duration of the first sleep visit
was 25 min and 19 min for subsequent visits.
Figure 1 Flow chart of participants. *All lost to follow-up due to failure to return questionnaires. Some families returned questionnaires at 10 but not 12
months and vice versa. Take-up of the intervention was voluntary. One hundred families reported receiving the intervention. `Did not return either the 10-
or 12-month follow-up questionnaire. MCH, Maternal and Child Health.
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Control mothers were more likely than intervention mothers
to have sought help from professional services for infant’s sleep
(33% vs 18%, p = 0.02; see table 5).
DISCUSSION
A brief behavioural intervention delivered by primary healthcare
professionals reduced infant sleep problems, improved maternal
mental health, and reduced the amount of paid professional help
sought for infant sleep problems 2 and 4 months after interven-
tion. Benefits occurred across a broad sociodemographic range
and at lower cost to the healthcare system.
This is the first trial examining the impact of a primary care
infant sleep intervention on infant sleep and maternal well-
being. Over 95% of mothers and all clusters remained in the
trial. Although only 72% of eligible mothers entered the study
at 4 months, their mean EPDS score (mean 6.8, standard
deviation (SD) 4.9) was similar to that reported in sample of
women in Victoria 8–9 months postpartum (mean 7.6, SD
4.8).
27
The prevalence of reported sleep problems (47%) was
similar to that in our earlier study
6
but higher than the 36%
reported by mothers in another community study of Australian
infants aged 7–9 months.
5
This might suggest that mothers
experiencing early sleep problems were more likely to enter the
study but should not limit generalisability to English-speaking
mothers with infant sleep problems in the general population.
There is no accepted definition of an infant sleep problem.
However, mothers who report an infant sleep problem are
known to have babies with longer and more frequent night
wakings and greater settling difficulties, and to suffer poorer
mental health.
6
Parents reporting a child sleep problem are also
more accurate reporters of their child’s sleep patterns than
parents not reporting a child sleep problem when compared
with over-night infra-red camera footage.
28
Neither nurses nor mothers could be blind to group
membership during the intervention and mothers’ self-reported
outcomes. This may have biased reports of the intervention
mothers towards an apparent benefit. However, intervention
mothers reported a worse physical health outcome which
argues against such a bias.
The trial demonstrated a sustained reduction in infant sleep
problems, similar in size to that reported in other trials of
behavioural interventions with shorter follow-up periods.
12
At
12 months, mean SF-12 mental health scores for intervention and
control mothers were 50 and 46, respectively. In a large,
representative Australian population survey, adults scoring 40–
49 vs >50 on the SF-12 were almost four times as likely to have a
current mental disorder, and more than twice as likely to have
impaired daily functioning.
29
Thus this trial’s SF-12 mental health
scores suggest an important impact on mental health disability.
Similarly, the improvement in maternal sleep quality and quantity
at 12 months might reduce other problems associated with
maternal sleep deprivation, that is, maternal overload and
dysfunction
30
and later child behaviour problems.
31
The chosen perspective of the economic evaluation meant we
excluded resource use and costs that fell solely on mothers, for
example out-of-pocket costs in accessing services. If the
intervention reduces use of professional health services (apart
from MCH nurses), it may well also reduce personal costs to
mothers as mothers usually live within walking distance of
their nurse’s centre. Although the costs for mothers in the
intervention arm were reduced relative to the control arm, the
confidence intervals for the difference suggest that the cost
could be greater in the intervention arm, in which case one
would need to consider incremental costs. Equally, intervention
costs could be even lower, as we included costs of material
development which would not be re-incurred if the programme
were taken up more widely.
In conclusion, this brief intervention was effective, feasible,
and acceptable to parents and primary healthcare providers
alike. Effects were consistent across measures and over time,
and occurred at a lower cost to the healthcare system. The
challenge now is to translate this intervention to the wider
population in a sustainable and feasible way.
ACKNOWLEDGEMENTS
We would like to thank the MCH nurses and families of the cities of
Bayside, Darebin, Hobson’s Bay, Manningham, Monash and the shire
of Yarra Ranges who took part in this study.
CONTRIBUTIONS
The trial design was formulated by HH and MW. JB, HH and AH
implemented the trial. Data management and analysis was implemen-
ted by OU, LG and AH with HH, MW and JB contributing to the
analysis plan. HH produced the first draft of the paper with all other
authors contributing to subsequent drafts. HH will act as guarantor for
the paper.
Authors’ affiliations
.......................
Harriet Hiscock, Jordana Bayer, Anne Hampton, Obioha C Ukoumunne,
Melissa Wake, Murdoch Childrens Research Institute, Parkville, Victoria,
Australia
Lisa Gold, School of Public Health, La Trobe University, Victoria, Australia
Funding: This project was funded by the National Health and Medical
Research Council Project, grant number 237120 and The Pratt Foundation.
Dr Hiscock was supported by the Murdoch Childrens Research Institute.
None of the funders played a role in the study design, collection analysis or
interpretation of the data or in the decision to submit.
Competing interests: None.
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2007 92: 952-958 originally published online DecemberArch Dis Child
Harriet Hiscock, Jordana Bayer, Lisa Gold, et al.
health: a cluster randomised trial
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