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

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00267579
First received: December 19, 2005
Last updated: March 27, 2013
Last verified: March 2013
  Purpose

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.


Condition Intervention Phase
Pediatric Disruptive Behaviour Disorder
Behavioral: Strongest Families (formerly Family Help Program): Behaviour Disorder Program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strongest Families (Formerly Family Help Program):Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Disruptive Behaviour Disorder)

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Alabama Parenting Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Revised Disruptive Disorder Rating Scale [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Connors rating scale [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Disability Measure; [ Time Frame: Weekly during treatment; baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Child Health Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Economic Outcome assessment [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: October 2003
Study Completion Date: April 2008
Primary Completion Date: September 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
50% randomized to receive Strongest Families (formerly Family Help Program): Behaviour treatment
Behavioral: Strongest Families (formerly Family Help Program): Behaviour Disorder Program
Evidence-based psychological and behavioural Distance Intervention
Other Name: Strongest Families (formerly Family Help Program):
Active Comparator: Control
50% randomized to control group: standard/usual care for behaviour disorder
Behavioral: Strongest Families (formerly Family Help Program): Behaviour Disorder Program
Evidence-based psychological and behavioural Distance Intervention
Other Name: Strongest Families (formerly Family Help Program):

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.

  Eligibility

Ages Eligible for Study:   3 Years to 7 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267579

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Patrick J. McGrath, PhD. IWK Health Centre
  More Information

Publications:
Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT00267579     History of Changes
Other Study ID Numbers: 2234b, CIHR CAHR-43273
Study First Received: December 19, 2005
Last Updated: March 27, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Mental Disorders
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood

ClinicalTrials.gov processed this record on April 21, 2014