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

IWK Health Centre

Status and phase: Completed; Phase 2

Conditions: Sleep Disorder

Treatments: Behavioral: FHP Sleep Program

Study type: Interventional

Funder types: Other

Identifiers

NCT00338429

3104

NSHRF grant (Other Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 61 patients

Sex: All

Ages: 5 to 12 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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61 participants in 2 patient groups

Treatment: FHP Sleep Program

Experimental group

Description:

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

Treatment:

Behavioral: FHP Sleep Program

Control: Usual Care

No Intervention group

Description:

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