Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached)

Phase 2

Completed

• Conditions: Sleep Disorder
• Interventions: Behavioral: FHP Sleep Program

• Registration Number: NCT00338429
• Lead Sponsor: IWK Health Centre

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.

Study Timeline

• Study Start: 2005-04
• Study First Submitted: 2006-06-15
• Study First Submitted QC: 2006-06-15
• Study First Posted: 2006-06-20
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment: FHP Sleep Program	FHP Sleep Program	Stratified with or without behavior Disorder Diagnosis (ADHD): 50% randomized to receive Better Days, Better Nights- sleep distance intervention

Primary Outcome Measures

Name	Time	Method
Child Sleep Habits Questionnaire	baseline, 2months (end of treatment) & 6 month follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada