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

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Better Days, Better Nights: Treatment for Sleep Difficulties

Official Title ^†

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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 ]

Condition ^†

Sleep Onset Latency and/or Bedtime Resistance

Intervention ^†

Behavioral: FHP Sleep Program

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

Start Date ^†

April 2005

Completion Date

June 2009

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

Gender

Both

Ages

5 Years to 12 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Canada

Administrative Information Fields

NCT ID ^†

NCT00338429

Organization ID

3104

Secondary IDs ^††

NSHRF grant

Study Sponsor ^†

IWK Health Centre

Collaborators ^††

Investigators ^†

Principal Investigator:

Penny Corkum, PhD.

IWK Health Centre and Dalhousie University

Information Provided By

IWK Health Centre

Verification Date

November 2008

First Received Date ^†

June 15, 2006

Last Updated Date

November 19, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.