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

Primary Purpose

Sleep Disorder

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
FHP Sleep Program
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Disorder focused on measuring sleep onset latency, bedtime resistance

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment: FHP Sleep Program

Control: Usual Care

Arm Description

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

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

Outcomes

Primary Outcome Measures

Child Sleep Habits Questionnaire

Secondary Outcome Measures

Sleep diary
Actigraph recordings
Child Behaviour Checklist (CBCL)
Satisfaction scale (researcher developed)
Parenting Stress Index
Child Health Questionnaire

Full Information

First Posted
June 15, 2006
Last Updated
September 1, 2016
Sponsor
IWK Health Centre
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1. Study Identification

Unique Protocol Identification Number
NCT00338429
Brief Title
Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached)
Acronym
Sleep
Official Title
Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
April 2005 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IWK Health Centre

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Disorder
Keywords
sleep onset latency, bedtime resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment: FHP Sleep Program
Arm Type
Experimental
Arm Description
Stratified with or without behavior Disorder Diagnosis (ADHD): 50% randomized to receive Better Days, Better Nights- sleep distance intervention
Arm Title
Control: Usual Care
Arm Type
No Intervention
Arm Description
Stratified with/without behavior diagnosis (ADHD): 50% randomized to receive usual care for sleep disorder
Intervention Type
Behavioral
Intervention Name(s)
FHP Sleep Program
Intervention Description
Cognitive-Behavioral Intervention
Primary Outcome Measure Information:
Title
Child Sleep Habits Questionnaire
Time Frame
baseline, 2months (end of treatment) & 6 month follow-up
Secondary Outcome Measure Information:
Title
Sleep diary
Time Frame
daily during treatment; on follow-up at 2 & 6 MONTHS post randomization
Title
Actigraph recordings
Time Frame
daily during treatment; baseline, 2 & 6 months follow-up
Title
Child Behaviour Checklist (CBCL)
Time Frame
baseline, 2months (end of treatment) & 6 month follow-up
Title
Satisfaction scale (researcher developed)
Time Frame
end of treatment
Title
Parenting Stress Index
Time Frame
baseline, 2months (end of treatment) & 6 month follow-up
Title
Child Health Questionnaire
Time Frame
baseline, 2months (end of treatment) & 6 month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Penny Corkum, PhD.
Organizational Affiliation
IWK Health Centre and Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate summary data would be made available but not individual data.
Citations:
PubMed Identifier
27189687
Citation
Corkum P, Lingley-Pottie P, Davidson F, McGrath P, Chambers CT, Mullane J, Laredo S, Woodford K, Weiss SK. Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial. J Pediatr Psychol. 2016 Jul;41(6):701-13. doi: 10.1093/jpepsy/jsw031. Epub 2016 May 16.
Results Reference
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Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached)

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