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

March 27, 2013 updated by: IWK Health Centre

Strongest Families (Formerly Family Help Program):Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Disruptive Behaviour Disorder)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Strongest Families (formerly Family Help Program):

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Time Frame: baseline, 120, 240 and 365 day follow-up
baseline, 120, 240 and 365 day follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Patrick J. McGrath, PhD., IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

September 1, 2006

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

December 19, 2005

First Submitted That Met QC Criteria

December 20, 2005

First Posted (Estimate)

December 21, 2005

Study Record Updates

Last Update Posted (Estimate)

March 29, 2013

Last Update Submitted That Met QC Criteria

March 27, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2234b
  • CIHR CAHR-43273 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pediatric Disruptive Behaviour Disorder

Clinical Trials on Strongest Families (formerly Family Help Program): Behaviour Disorder Program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe