title: 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.
  
  
  BACKGROUND
  ISRCTN42169337 , NCT00877162.
authors.affiliation: University of British Columbia School of Nursing, T 201, 2211 Wesbrook Mall, Vancouver, BC, V6T 2B5, Canada. wendy.hall@ubc.ca.
authors.forename: Wendy A
authors.initials: WA
authors.lastname: Hall
authors.affiliation: Midwifery Education Program, McMaster University, Michael G DeGroote Centre for Learning & Discovery, Room 2210, 1200 Main Street West, Hamilton, ON, L8N 3Z5, Canada. huttone@mcmaster.ca.
authors.forename: Eileen
authors.initials: E
authors.lastname: Hutton
authors.affiliation: Department of Statistics, University of British Columbia/Child and Family Research Institute, ESB 3146, 2207 Main Mall, Vancouver, BC, V6T 1Z4, Canada. rbrant@cfri.ca.
authors.forename: Rollin F
authors.initials: RF
authors.lastname: Brant
authors.affiliation: Child and Family Research Institute, University of British Columbia, Clinical Support Building, Room V3-320, 948 West 28th Avenue, Vancouver, BC, V6H 3N1, Canada. jpcollet@gmail.com.
authors.forename: Jean Paul
authors.initials: JP
authors.lastname: Collet
authors.affiliation: University of British Columbia School of Nursing, Vancouver, BC, Canada. greggkathy@gmail.com.
authors.forename: Kathy
authors.initials: K
authors.lastname: Gregg
authors.affiliation: University of British Columbia Faculty of Medicine, 2329 West Mall, Vancouver, BC, V6T 1Z4, Canada. RoboDoc@telus.net.
authors.forename: Roy
authors.initials: R
authors.lastname: Saunders
authors.affiliation: British Columbia Children's Hospital, Division of Developmental Pediatrics, 3644 Slocan Street, Vancouver, BC, V5M 3E8, Canada. oipsiroglu@cw.bc.ca.
authors.forename: Osman
authors.initials: O
authors.lastname: Ipsiroglu
authors.affiliation: Department of Clinical Epidemiology and Biostatistics, Faculty of Health Sciences, McMaster University, 1280 Main Street West, CRL-208, Hamilton, ON, L8S 4K1, Canada. gafni@mcmaster.ca.
authors.forename: Amiram
authors.initials: A
authors.lastname: Gafni
authors.affiliation: Pacific Spirit Community Health Centre, Vancouver Coastal Health, 2110 43rd Avenue West, Vancouver, BC, V6M 2E1, Canada. Kathy.Triolet@vch.ca.
authors.forename: Kathy
authors.initials: K
authors.lastname: Triolet
authors.affiliation: South Community Health Centre, Vancouver Coastal Health, 6405 Knight Street, Vancouver, BC, V5P 2V9, Canada. Lillian.Tse@vch.ca.
authors.forename: Lillian
authors.initials: L
authors.lastname: Tse
authors.affiliation: South Community Health Centre, Vancouver Community, Vancouver Coastal Health, 6405 Knight Street, Vancouver, BC, V5P 2V9, Canada. Radhika.Bhagat@vch.ca.
authors.forename: Radhika
authors.initials: R
authors.lastname: Bhagat
authors.affiliation: Early Childhood Development at Vancouver Coastal Health, Vancouver Coastal Health, 11th floor, 601 West Broadway, Vancouver, BC, V5Z 4C2, Canada. Joanne.Wooldridge@vch.ca.
authors.forename: Joanne
authors.initials: J
authors.lastname: Wooldridge
mesh_terms: D056044:Actigraphy; D000328:Adult; D000339:Affect; D015928:Cognitive Behavioral Therapy; D005221:Fatigue; D005260:Female; D006801:Humans; D007223:Infant; D018730:Infant Behavior / Q000523:psychology*; D008297:Male; D010290:Parents / Q000523:psychology*; D011615:Psychotherapy, Group; D012890:Sleep