Better Days, Better Nights: Treatment for Sleep Difficulties - Full Text View

Sponsored by:	IWK Health Centre
Information provided by:	IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00338429

Purpose

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).

Condition	Intervention	Phase
Sleep Onset Latency and/or Bedtime Resistance	Behavioral: FHP Sleep Program	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	80
Study Start Date:	April 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental Stratified with or without behavior Disorder Diagnosis: 50% randomized to receive sleep distance intervention	Behavioral: FHP Sleep Program Cognitive-Behavioral Intervention
Control: No Intervention Stratified with/without behavior diagnosis: 50% randomized to receive usual care for sleep disorder	Behavioral: FHP Sleep Program Cognitive-Behavioral Intervention

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.

Eligibility

Ages Eligible for Study:	5 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338429

Locations

Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8

Sponsors and Collaborators

IWK Health Centre

Investigators

Principal Investigator:

Penny Corkum, PhD.

IWK Health Centre and Dalhousie University

More Information

Responsible Party:	Dalhousie University ( dr. penny corkum )
Study ID Numbers:	3104, NSHRF grant
Study First Received:	June 15, 2006
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00338429
Health Authority:	Canada: Ethics Review Committee

Keywords provided by IWK Health Centre:

sleep onset latency
bedtime resistance

ClinicalTrials.gov processed this record on January 14, 2009