Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached) (Sleep)
September 1, 2016 updated by: IWK Health Centre
Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)
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).
Study Overview
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 Type
Interventional
Enrollment (Actual)
61
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- IWK Health Centre
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years to 12 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Treatment: FHP Sleep Program
Stratified with or without behavior Disorder Diagnosis (ADHD): 50% randomized to receive Better Days, Better Nights- sleep distance intervention
|
Cognitive-Behavioral Intervention
|
|
NO_INTERVENTION: Control: Usual Care
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 |
Time Frame |
|---|---|
|
Child Sleep Habits Questionnaire
Time Frame: baseline, 2months (end of treatment) & 6 month follow-up
|
baseline, 2months (end of treatment) & 6 month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Sleep diary
Time Frame: daily during treatment; on follow-up at 2 & 6 MONTHS post randomization
|
daily during treatment; on follow-up at 2 & 6 MONTHS post randomization
|
|
Actigraph recordings
Time Frame: daily during treatment; baseline, 2 & 6 months follow-up
|
daily during treatment; baseline, 2 & 6 months follow-up
|
|
Child Behaviour Checklist (CBCL)
Time Frame: baseline, 2months (end of treatment) & 6 month follow-up
|
baseline, 2months (end of treatment) & 6 month follow-up
|
|
Satisfaction scale (researcher developed)
Time Frame: end of treatment
|
end of treatment
|
|
Parenting Stress Index
Time Frame: baseline, 2months (end of treatment) & 6 month follow-up
|
baseline, 2months (end of treatment) & 6 month follow-up
|
|
Child Health Questionnaire
Time Frame: baseline, 2months (end of treatment) & 6 month follow-up
|
baseline, 2months (end of treatment) & 6 month follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Penny Corkum, PhD., IWK Health Centre and Dalhousie University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2005
Primary Completion (ACTUAL)
May 1, 2009
Study Completion (ACTUAL)
May 1, 2009
Study Registration Dates
First Submitted
June 15, 2006
First Submitted That Met QC Criteria
June 15, 2006
First Posted (ESTIMATE)
June 20, 2006
Study Record Updates
Last Update Posted (ESTIMATE)
September 2, 2016
Last Update Submitted That Met QC Criteria
September 1, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3104
- NSHRF grant (OTHER: nshrf)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Aggregate summary data would be made available but not individual data.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.