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Better Days, Better Nights: Treatment for Sleep Difficulties
This study is ongoing, but not recruiting participants.
Study NCT00338429.   Last updated on November 19, 2008.
Information provided by IWK Health Centre
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Better Days, Better Nights: Treatment for Sleep Difficulties
Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)

The purpose of the Family Help Sleep Difficulties Program is to determine if Family Help distance intervention is as effective as usual or standard care typically provided to children with mild to moderate sleep onset latency and/or bedtime resistance difficulties. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in sleep patterns (sleep onset latency and/or bedtime resistance).

The purpose of the Family Help Sleep Program is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 80 children (6-12 years of age)suffering from mild to moderate sleep onset latency and/or bedtime resistance will be randomized.

The intervention is delivered from a distance, using an educational handbook and telephone consultation with a trained paraprofessional "coach" who is supervised by a licensed health care professional. The telephone coach delivers consistent care based on written protocols, with on-going evaluation by a professional team.

Phase II
Interventional
Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Child Sleep Habits Questionnaire [ Time Frame: baseline, 2months & 6 month follow-up ] [ Designated as safety issue: No ]
Sleep diary [ Time Frame: daily during treatment; on follow-up at 2 & 6 MONTHS post randomization ] [ Designated as safety issue: No ]
Actigraph recordings [ Time Frame: daily during treatment; baseline, 2 & 6 months follow-up ] [ Designated as safety issue: No ]
Sleep Onset Latency and/or Bedtime Resistance
Behavioral: FHP Sleep Program
 
Active, not recruiting
80
April 2005
June 2009

Inclusion Criteria:

  • children 5-12 years of age
  • attending grades primary-6 (Elementary School)
  • sleep onset latency and/or bedtime resistance
  • speak and write English
  • provides parental authorization
  • has access to telephone in home

Exclusion Criteria:

  • any mental health disease with the exclusion of disruptive behavior disorder
  • neurological conditions
  • moderate to severe cognitive impairment
  • has received a behavioral intervention for sleep difficulties in the past 6 months
  • nocturnal enuresis
  • sleep apnea
  • co-sleeping
Both
5 Years to 12 Years
Yes
Canada
 
NCT00338429
3104
NSHRF grant
IWK Health Centre
Principal Investigator: Penny Corkum, PhD. IWK Health Centre and Dalhousie University
IWK Health Centre
November 2008
June 15, 2006
November 19, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.