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

Hall WA, Hutton E, Brant RF, Collet JP, Gregg K, Saunders R, Ipsiroglu O, Gafni A, Triolet K, Tse L, Bhagat R, Wooldridge J - BMC Pediatr (2015)

Bottom Line: 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).The intervention improved caregivers' assessments of infant sleep problem severity and parental depression, fatigue, sleep, and sleep cognitions compared with controls.ISRCTN42169337 , NCT00877162.

View Article: PubMed Central - PubMed

Affiliation: University of British Columbia School of Nursing, T 201, 2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada. wendy.hall@ubc.ca.

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.

No MeSH data available.


Related in: MedlinePlus

Participant Flowchart (CONSORT)
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
getmorefigures.php?uid=PMC4643535&req=5

Fig1: Participant Flowchart (CONSORT)

Mentions: After the study coordinator enrolled families and research assistants obtained consent and baseline measurements, families were randomly allocated in sequential blocks of 10 to intervention (sleep) and control groups (safety) at each site (Fig. 1). The sequential blocks were to ensure that families were equally distributed by group designation and geographic area (4 health unit sites). A data manager used a computerized secure software platform to randomly assign families to groups.Fig. 1


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

Hall WA, Hutton E, Brant RF, Collet JP, Gregg K, Saunders R, Ipsiroglu O, Gafni A, Triolet K, Tse L, Bhagat R, Wooldridge J - BMC Pediatr (2015)

Participant Flowchart (CONSORT)
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4643535&req=5

Fig1: Participant Flowchart (CONSORT)
Mentions: After the study coordinator enrolled families and research assistants obtained consent and baseline measurements, families were randomly allocated in sequential blocks of 10 to intervention (sleep) and control groups (safety) at each site (Fig. 1). The sequential blocks were to ensure that families were equally distributed by group designation and geographic area (4 health unit sites). A data manager used a computerized secure software platform to randomly assign families to groups.Fig. 1

Bottom Line: 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).The intervention improved caregivers' assessments of infant sleep problem severity and parental depression, fatigue, sleep, and sleep cognitions compared with controls.ISRCTN42169337 , NCT00877162.

View Article: PubMed Central - PubMed

Affiliation: University of British Columbia School of Nursing, T 201, 2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada. wendy.hall@ubc.ca.

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.

No MeSH data available.


Related in: MedlinePlus