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

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ClinicalTrials.gov Identifier: NCT00338429
Recruitment Status : Completed
First Posted : June 20, 2006
Last Update Posted : September 2, 2016
Information provided by (Responsible Party):

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).

Condition or disease Intervention/treatment Phase
Sleep Disorder Behavioral: FHP Sleep Program Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)
Study Start Date : April 2005
Primary Completion Date : May 2009
Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Child Sleep Habits Questionnaire [ Time Frame: baseline, 2months (end of treatment) & 6 month follow-up ]

Secondary Outcome Measures :
  1. Sleep diary [ Time Frame: daily during treatment; on follow-up at 2 & 6 MONTHS post randomization ]
  2. Actigraph recordings [ Time Frame: daily during treatment; baseline, 2 & 6 months follow-up ]
  3. Child Behaviour Checklist (CBCL) [ Time Frame: baseline, 2months (end of treatment) & 6 month follow-up ]
  4. Satisfaction scale (researcher developed) [ Time Frame: end of treatment ]
  5. Parenting Stress Index [ Time Frame: baseline, 2months (end of treatment) & 6 month follow-up ]
  6. Child Health Questionnaire [ Time Frame: baseline, 2months (end of treatment) & 6 month follow-up ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00338429

Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Principal Investigator: Penny Corkum, PhD. IWK Health Centre and Dalhousie University
More Information

Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT00338429     History of Changes
Other Study ID Numbers: 3104
NSHRF grant ( Other Identifier: nshrf )
First Posted: June 20, 2006    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Mental Disorders