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

September 1, 2016 updated by: IWK Health Centre

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Child Sleep Habits Questionnaire
Time Frame: baseline, 2months (end of treatment) & 6 month follow-up
baseline, 2months (end of treatment) & 6 month follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Investigators

  • Principal Investigator: Penny Corkum, PhD., IWK Health Centre and Dalhousie University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

June 15, 2006

First Submitted That Met QC Criteria

June 15, 2006

First Posted (ESTIMATE)

June 20, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

September 2, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3104
  • NSHRF grant (OTHER: nshrf)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate summary data would be made available but not individual data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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