Dataset Information

A randomized controlled trial of an intervention for infants' behavioral sleep problems.

ABSTRACT: BACKGROUND:Infant behavioral sleep problems are common, with potential negative consequences. We conducted a randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teaching session and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes or parent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue, sleep, and parent cognitions about infant sleep. METHODS:Two hundred thirty five families of six-to-eight month-old infants were randomly allocated to intervention (n?=?117) or to control teaching sessions (n?=?118) where parents received instruction on infant safety. Outcome measures were observed at baseline and at 6 weeks post intervention. Nightly observation was based on actigraphy and sleep diaries over six days. Secondary outcomes were derived from the Multidimensional Assessment of Fatigue Scale, Center for Epidemiologic Studies Depression Measure, Pittsburgh Sleep Quality Index, and Maternal (parental) Cognitions about Infant Sleep Questionnaire. RESULTS:One hundred eight intervention and 107 control families provided six-week follow-up information with complete actigraphy data for 96 in each group: 96.9% of intervention and 97.9% of control infants had an average of 2 or more nightly wakes, a risk difference of -0.2% (95% CI: -1.32, 0.91). 4% of intervention and 14% of control infants had parent-assessed severe sleep problems: relative risk 0.3, a risk difference of -10% (CI: 0.11, 0.84-16.8 to -2.2). Relative to controls, intervention parents reported improved baseline-adjusted parental depression (CI: -3.7 to -0.4), fatigue (CI: -5.74 to -1.68), sleep quality (CI: -1.5 to -0.2), and sleep cognitions: doubts (CI: -2.0 to -0.6), feeding (CI: - 2.1 to - 0.7), anger (CI: - 1.8 to - 0.4) and setting limits (CI: -3.5 to -1.5). CONCLUSIONS:The intervention improved caregivers' assessments of infant sleep problem severity and parental depression, fatigue, sleep, and sleep cognitions compared with controls. TRIAL REGISTRATION:ISRCTN42169337 , NCT00877162.

SUBMITTER: Hall WA

PROVIDER: S-EPMC4643535 | biostudies-literature | 2015 Nov

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

A randomized controlled trial of an intervention for infants' behavioral sleep problems.

Hall Wendy A WA Hutton Eileen E Brant Rollin F RF Collet Jean Paul JP Gregg Kathy K Saunders Roy R Ipsiroglu Osman O Gafni Amiram A Triolet Kathy K Tse Lillian L Bhagat Radhika R Wooldridge Joanne J

BMC pediatrics 20151113

<h4>Background</h4>Infant behavioral sleep problems are common, with potential negative consequences. We conducted a randomized controlled trial to assess effects of a sleep intervention comprising a two-hour group teaching session and four support calls over 2 weeks. Our primary outcomes were reduced numbers of nightly wakes or parent report of sleep problem severity. Secondary outcomes included improvement in parental depression, fatigue, sleep, and parent cognitions about infant sleep.<h4>Met ...[more]

PMID: 26567090

Similar Datasets

Project description:BackgroundWeb-based interventions have been shown to be effective for the treatment of depression. However, interventions are often complex and include a variety of elements, making it difficult to identify the most effective component(s).ObjectiveThe aim of this pilot study was to shed light on mechanisms in the online treatment of depression by comparing a single-module, fully automated intervention for depression (internet-based behavioral activation [iBA]) to a nonoverlapping active control intervention and a nonactive control group.MethodsWe assessed 104 people with at least mild depressive symptoms (Patient Health Questionnaire-9, >4) via the internet at baseline (t0) and 2 weeks (t1) and 4 weeks (t2) later. After the t0 assessment, participants were randomly allocated to one of three groups: (1) iBA (n=37), (2) active control using a brief internet-based mindfulness intervention (iMBI, n=32), or (3) care as usual (CAU, n=35). The primary outcome was improvement in depressive symptoms, as measured using the Patient Health Questionnaire-9. Secondary parameters included changes in activity, dysfunctional attitudes, and quality of life.ResultsWhile groups did not differ regarding the change in depression from t0 to t1 (?p2=.007, P=.746) or t0 to t2 (?p2=.008, P=.735), iBA was associated with a larger decrease in dysfunctional attitudes from t0 to t2 in comparison to CAU (?p2=.053, P=.04) and a larger increase in activity from t0 to t1 than the pooled control groups (?p2=.060, P=.02). A change in depression from t0 to t2 was mediated by a change in activity from t0 to t1. At t1, 22% (6/27) of the participants in the iBA group and 12% (3/25) of the participants in the iMBI group indicated that they did not use the intervention.ConclusionsAlthough we did not find support for the short-term efficacy of the single-module iBA regarding depression, long-term effects are still conceivable, potentially initiated by changes in secondary outcomes. Future studies should use a longer intervention and follow-up interval.Trial registrationDKRS (#DRKS00011562).

Dataset Information

A randomized controlled trial of an intervention for infants' behavioral sleep problems.

Publications

A randomized controlled trial of an intervention for infants' behavioral sleep problems.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets