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

Sleep Disorder Clinical Trial

— Sleep  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00338429
• Other study ID #: 3104
• Secondary ID: NSHRF grant
• Status: Completed
• Phase: Phase 2
• First received: June 15, 2006
• Last updated: September 1, 2016
• Start date: April 2005
• Est. completion date: May 2009

Study information

• Verified date: September 2016
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parasomnias
• Sleep Disorder
• Sleep Wake Disorders

Intervention

Behavioral:
• FHP Sleep Program
Cognitive-Behavioral Intervention

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Child Sleep Habits Questionnaire		baseline, 2months (end of treatment) & 6 month follow-up	No
Secondary	Sleep diary		daily during treatment; on follow-up at 2 & 6 MONTHS post randomization	No
Secondary	Actigraph recordings		daily during treatment; baseline, 2 & 6 months follow-up	No
Secondary	Child Behaviour Checklist (CBCL)		baseline, 2months (end of treatment) & 6 month follow-up	No
Secondary	Satisfaction scale (researcher developed)		end of treatment	No
Secondary	Parenting Stress Index		baseline, 2months (end of treatment) & 6 month follow-up	No
Secondary	Child Health Questionnaire		baseline, 2months (end of treatment) & 6 month follow-up	No