Strongest Families (Formerly Family Help Program): Pediatric Disruptive Behaviour Disorder

Phase 2

Completed

• Conditions: Pediatric Disruptive Behaviour Disorder

• Registration Number: NCT00267579
• Lead Sponsor: IWK Health Centre

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 Disruptive Behaviour symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

Detailed Description

The purpose of the Strongest Families (formerly Family Help Program): is to deliver, primary care mental health services to children and their families in the comfort and privacy of their own home. Approximately 60 children (3-7 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric behavior disorder will be randomized.

The intervention is delivered from a distance, using educational materials (manuals, video-tapes, audio-tapes) 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.

Fifty percent of the eligible participants will receive Family Help Program telephone-based treatment and 50% will be referred back to their family physician to receive standard care as determined by that physician. Those receiving standard care will be evaluated for outcome results and then compared to the Strongest Families treated participants. It is anticipated that Strongest Families treatment will be proven to be as or more effective than standard care.

Study Timeline

• Study Start: 2003-10
• Study First Submitted: 2005-12-19
• Study First Submitted QC: 2005-12-20
• Study First Posted: 2005-12-21
• Primary Completion: 2006-09
• Study Completion: 2008-04
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-27
• Last Update Posted: 2013-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• child 3 to 7 years of age
• child had behavioural problems for 6 months or longer
• access to a telephone in the home
• speak and write english
• mild to moderate disruptive behaviour symptomology

Exclusion Criteria

• severe disruptive behaviour symptomology
• received similar intervention within past 6 months
• Autism or Schizophrenia
• child has intellectual impairment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.	baseline, 120, 240 and 365 day follow-up

Secondary Outcome Measures

Name	Time	Method
Alabama Parenting Questionnaire	baseline, 120, 240 and 365 day follow-up
Revised Disruptive Disorder Rating Scale	baseline, 120, 240 and 365 day follow-up
Connors rating scale	baseline, 120, 240 and 365 day follow-up
Disability Measure;	Weekly during treatment; baseline, 120, 240 and 365 day follow-up
Child Health Questionnaire	baseline, 120, 240 and 365 day follow-up
Economic Outcome assessment	baseline, 120, 240 and 365 day follow-up

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada