Strongest Families (Formerly Family Help Program): Pediatric Attention Deficit/Hyperactivity Disorder (FHPADHD)

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00267605
First received: December 19, 2005
Last updated: March 27, 2013
Last verified: March 2013

December 19, 2005
March 27, 2013
June 2003
June 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 NCT00267605 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 Attention Deficit/Hyperactivity Disorder
Strongest Families (Formerly Family Help Program): Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Attention Deficit/Hyperactivity 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 Attention Deficit/Hyperactivity Disorder. 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 (8-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Attention Deficit/Hyperactivity 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 Strongest Families (formerly 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
Attention Deficit/Hyperactivity Disorder
  • Behavioral: FHPADHD
    Evidence-based psychological and behavioural distance intervention
    Other Name: Strongest Families (formerly Family Help Program):
  • Behavioral: ADHD Standard Care
  • Experimental: Treatment
    FHPADHD 50% randomized to receive Strongest Families (formerly Family Help Program): behavioural distance intervention
    Intervention: Behavioral: FHPADHD
  • Active Comparator: Control
    ADHD Standard Care 50% randomized to receive standard/usual care for ADHD
    Intervention: Behavioral: ADHD Standard Care

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
72
April 2008
June 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 attention deficit/hyperactivity symptomology

Exclusion Criteria:

  • severe attention deficit/hyperactivity symptomology
  • received similar intervention within past 6 months
  • Autism or Schizophrenia
  • child has intellectual impairment
Both
8 Years to 12 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00267605
2234c, CHIR 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