Clinical trial NCT00338429: Better Days, Better Nights: Treatment for Sleep Difficulties (Telephone Coached)
Official title: Better Days, Better Nights: Treatment for Sleep Difficulties (A Sleep Intervention Module of the Family Help Program)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Sleep Disorder
Keywords: sleep onset latency
bedtime resistance
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
First posted: 2006-06-20
Enrollment: 61
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Child Sleep Habits Questionnaire
timeFrame: baseline, 2months (end of treatment) & 6 month follow-up
Secondary outcomes:
measure: Sleep diary
timeFrame: daily during treatment; on follow-up at 2 & 6 MONTHS post randomization
measure: Actigraph recordings
timeFrame: daily during treatment; baseline, 2 & 6 months follow-up
measure: Child Behaviour Checklist (CBCL)
timeFrame: baseline, 2months (end of treatment) & 6 month follow-up
measure: Satisfaction scale (researcher developed)
timeFrame: end of treatment
measure: Parenting Stress Index
timeFrame: baseline, 2months (end of treatment) & 6 month follow-up
measure: Child Health Questionnaire
timeFrame: baseline, 2months (end of treatment) & 6 month follow-up
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre and Dalhousie University
name: Penny Corkum, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.