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Completed

NCT Number: NCT00338429

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

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).

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Key information

Conditions

Sleep Disorder Mental Disorders Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Sleep Wake Disorders

Age range

5 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FHP Sleep Program

Behavioral

Cognitive-Behavioral Intervention

Primary outcomes

  1. Child Sleep Habits Questionnaire

    Time frame: baseline, 2months (end of treatment) & 6 month follow-up

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Registry information

Official study title

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

Acronym: Sleep

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jun 20, 2006
Registry last updated
Sep 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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