Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Sleep Disorder
- Sponsor
- IWK Health Centre
- Enrollment
- 61
- Locations
- 1
- Primary Endpoint
- Child Sleep Habits Questionnaire
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of the Strongest Families (formerly Family Help Program)is to evaluate the effectiveness of the Strongest Families distance intervention compared to usual or standard care that is 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).
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Child Sleep Habits Questionnaire
Time Frame: baseline, 2months (end of treatment) & 6 month follow-up
Secondary Outcomes
- Child Behaviour Checklist (CBCL)(baseline, 2months (end of treatment) & 6 month follow-up)
- Satisfaction scale (researcher developed)(end of treatment)
- Parenting Stress Index(baseline, 2months (end of treatment) & 6 month follow-up)
- Actigraph recordings(daily during treatment; baseline, 2 & 6 months follow-up)
- Sleep diary(daily during treatment; on follow-up at 2 & 6 MONTHS post randomization)
- Child Health Questionnaire(baseline, 2months (end of treatment) & 6 month follow-up)