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

Study 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.

Official Title
-----------------
Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)

Conditions
-----------------
Sleep Disorder

Intervention / Treatment
-----------------
* Behavioral: FHP Sleep Program


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment: FHP Sleep Program<br>Stratified with or without behavior Disorder Diagnosis (ADHD): 50% randomized to receive Better Days, Better Nights- sleep distance intervention | Behavioral: FHP Sleep Program<br>* Cognitive-Behavioral Intervention<br>|
| No Intervention: Control: Usual Care<br>Stratified with/without behavior diagnosis (ADHD): 50% randomized to receive usual care for sleep disorder | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child Sleep Habits Questionnaire |  | baseline, 2months (end of treatment) & 6 month follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep diary |  | daily during treatment; on follow-up at 2 & 6 MONTHS post randomization | 
| Actigraph recordings |  | daily during treatment; baseline, 2 & 6 months follow-up | 
| 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 | 
| Child Health Questionnaire |  | baseline, 2months (end of treatment) & 6 month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep onset latency, bedtime resistance