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

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ClinicalTrials.gov Identifier: NCT00267579
Recruitment Status : Completed
First Posted : December 21, 2005
Last Update Posted : March 29, 2013
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre

Tracking Information
First Submitted Date  ICMJE December 19, 2005
First Posted Date  ICMJE December 21, 2005
Last Update Posted Date March 29, 2013
Study Start Date  ICMJE October 2003
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 20, 2008)
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 20, 2005)
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2013)
  • Alabama Parenting Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
  • Revised Disruptive Disorder Rating Scale [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
  • Connors rating scale [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
  • Disability Measure; [ Time Frame: Weekly during treatment; baseline, 120, 240 and 365 day follow-up ]
  • Child Health Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
  • Economic Outcome assessment [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 20, 2005)
  • Specific Behavioural Measures:
  • Alabama Parenting Questionnaire
  • Revised Disruptive Disorder Rating Scale
  • Connors rating scale\
  • Other:
  • Disability Measure;
  • Child Health Questionnaire
  • Economic Outcome assessment
  • gathered at baseline, 120, 240 and 365 day follow-up.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strongest Families (Formerly Family Help Program): Pediatric Disruptive Behaviour Disorder
Official Title  ICMJE Strongest Families (Formerly Family Help Program):Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Disruptive Behaviour Disorder)
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Pediatric Disruptive Behaviour Disorder
Intervention  ICMJE 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):
Study Arms  ICMJE
  • Experimental: Treatment
    50% randomized to receive Strongest Families (formerly Family Help Program): Behaviour treatment
    Intervention: Behavioral: Strongest Families (formerly Family Help Program): Behaviour Disorder Program
  • Active Comparator: Control
    50% randomized to control group: standard/usual care for behaviour disorder
    Intervention: Behavioral: Strongest Families (formerly Family Help Program): Behaviour Disorder Program
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2008)
80
Original Enrollment  ICMJE
 (submitted: December 20, 2005)
60
Actual Study Completion Date  ICMJE April 2008
Actual Primary Completion Date September 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 3 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00267579
Other Study ID Numbers  ICMJE 2234b
CIHR CAHR-43273
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party IWK Health Centre
Study Sponsor  ICMJE IWK Health Centre
Collaborators  ICMJE Canadian Institutes of Health Research (CIHR)
Investigators  ICMJE
Principal Investigator: Patrick J. McGrath, PhD. IWK Health Centre
PRS Account IWK Health Centre
Verification Date March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP