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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2009-05-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Sleep Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment: FHP Sleep Program

Stratified with or without behavior Disorder Diagnosis (ADHD): 50% randomized to receive Better Days, Better Nights- sleep distance intervention

Group Type EXPERIMENTAL

FHP Sleep Program

Intervention Type BEHAVIORAL

Cognitive-Behavioral Intervention

Control: Usual Care

Stratified with/without behavior diagnosis (ADHD): 50% randomized to receive usual care for sleep disorder

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FHP Sleep Program

Cognitive-Behavioral Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes