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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

December 19, 2005
March 27, 2013
October 2003
September 2006   (final data collection date for primary outcome measure)
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 ]
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Complete list of historical versions of study NCT00267579 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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.
Not Provided
Not Provided
 
Strongest Families (Formerly Family Help Program): Pediatric Disruptive Behaviour Disorder
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Pediatric Disruptive 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):
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
April 2008
September 2006   (final data collection date for primary outcome measure)

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
Both
3 Years to 7 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00267579
2234b, CIHR CAHR-43273
No
IWK Health Centre
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Patrick J. McGrath, PhD. IWK Health Centre
IWK Health Centre
March 2013

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