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

NCT00338429 | Completed Phase 2

• 2 other identifiers: 3104NSHRF grant
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep Disorder

Keywords

sleep onset latency; bedtime resistance

Outcome Measures

Primary Outcomes (1)

• Child Sleep Habits Questionnaire

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

Secondary Outcomes (6)

• Sleep diary

  daily during treatment; on follow-up at 2 & 6 MONTHS post randomization

• Actigraph recordings

  daily during treatment; baseline, 2 & 6 months follow-up

• Child Behaviour Checklist (CBCL)

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

• Satisfaction scale (researcher developed)

  end of treatment

• Parenting Stress Index

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

Study Arms (2)

Treatment: FHP Sleep Program

EXPERIMENTAL

Stratified with or without behavior Disorder Diagnosis (ADHD): 50% randomized to receive Better Days, Better Nights- sleep distance intervention

Behavioral: FHP Sleep Program

Control: Usual Care

NO INTERVENTION

Stratified with/without behavior diagnosis (ADHD): 50% randomized to receive usual care for sleep disorder

Interventions

FHP Sleep Program BEHAVIORAL

Cognitive-Behavioral Intervention

Treatment: FHP Sleep Program

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

Related Publications (1)

• Corkum P, Lingley-Pottie P, Davidson F, McGrath P, Chambers CT, Mullane J, Laredo S, Woodford K, Weiss SK. Better Nights/Better Days-Distance Intervention for Insomnia in School-Aged Children With/Without ADHD: A Randomized Controlled Trial. J Pediatr Psychol. 2016 Jul;41(6):701-13. doi: 10.1093/jpepsy/jsw031. Epub 2016 May 16.

  PMID: 27189687 BACKGROUND

MeSH Terms

Conditions

Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Penny Corkum, PhD.

  IWK Health Centre and Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2006
• First Posted: June 20, 2006
• Study Start: April 1, 2005
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 2, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)