Better Days, Better Nights: Treatment for Sleep Difficulties - Tabular View

Tracking Information

First Received Date ^ICMJE

June 15, 2006

Last Updated Date

November 19, 2008

Start Date ^ICMJE

April 2005

Current Primary Outcome Measures ^ICMJE

Child Sleep Habits Questionnaire [ Time Frame: baseline, 2months & 6 month follow-up ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00338429 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Sleep diary [ Time Frame: daily during treatment; on follow-up at 2 & 6 MONTHS post randomization ] [ Designated as safety issue: No ]
Actigraph recordings [ Time Frame: daily during treatment; baseline, 2 & 6 months follow-up ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Sleep diary
Actigraph recordings

Descriptive Information

Brief Title ^ICMJE

Better Days, Better Nights: Treatment for Sleep Difficulties

Official Title ^ICMJE

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

Brief Summary

The purpose of the Family Help Sleep Difficulties Program is to determine if Family Help distance intervention is as effective as usual or standard care 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 Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Sleep Onset Latency and/or Bedtime Resistance

Intervention ^ICMJE

Behavioral: FHP Sleep Program

Study Arms / Comparison Groups

Experimental: Stratified with or without behavior Disorder Diagnosis: 50% randomized to receive sleep distance intervention
No Intervention: Stratified with/without behavior diagnosis: 50% randomized to receive usual care for sleep disorder

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Estimated Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

5 Years to 12 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Canada

Expanded Access Status

Administrative Information

NCT ID ^ICMJE

NCT00338429

Responsible Party

dr. penny corkum, Dalhousie University

Secondary IDs ^ICMJE

NSHRF grant

Study Sponsor ^ICMJE

IWK Health Centre

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Penny Corkum, PhD.

IWK Health Centre and Dalhousie University

Information Provided By

IWK Health Centre

Verification Date

November 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP