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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00338429
First received: June 15, 2006
Last updated: September 1, 2016
Last verified: September 2016
  Purpose
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).

Condition Intervention Phase
Sleep Disorder
Behavioral: FHP Sleep Program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Child Sleep Habits Questionnaire [ Time Frame: baseline, 2months (end of treatment) & 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 ]
  • Child Behaviour Checklist (CBCL) [ Time Frame: baseline, 2months (end of treatment) & 6 month follow-up ] [ Designated as safety issue: No ]
  • Satisfaction scale (researcher developed) [ Time Frame: end of treatment ] [ Designated as safety issue: No ]
  • Parenting Stress Index [ Time Frame: baseline, 2months (end of treatment) & 6 month follow-up ] [ Designated as safety issue: No ]
  • Child Health Questionnaire [ Time Frame: baseline, 2months (end of treatment) & 6 month follow-up ] [ Designated as safety issue: No ]

Enrollment: 61
Study Start Date: April 2005
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment: FHP Sleep Program
Stratified with or without behavior Disorder Diagnosis (ADHD): 50% randomized to receive Better Days, Better Nights- sleep distance intervention
Behavioral: FHP Sleep Program
Cognitive-Behavioral Intervention
No Intervention: Control: Usual Care
Stratified with/without behavior diagnosis (ADHD): 50% randomized to receive usual care for sleep disorder

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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT00338429     History of Changes
Other Study ID Numbers: 3104  NSHRF grant 
Study First Received: June 15, 2006
Last Updated: September 1, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Aggregate summary data would be made available but not individual data.

Keywords provided by IWK Health Centre:
sleep onset latency
bedtime resistance

Additional relevant MeSH terms:
Sleep Wake Disorders
Parasomnias
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on December 07, 2016