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Clinical Trials/NCT00267605
NCT00267605
Completed
Phase 2

Strongest Families (Formerly Family Help Program): Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Attention Deficit/Hyperactivity Disorder)

IWK Health Centre1 site in 1 country72 target enrollmentJune 2003

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Attention Deficit/Hyperactivity Disorder
Sponsor
IWK Health Centre
Enrollment
72
Locations
1
Primary Endpoint
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Status
Completed
Last Updated
9 years ago

Overview

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 Attention Deficit/Hyperactivity Disorder. 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 (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.

Registry
clinicaltrials.gov
Start Date
June 2003
End Date
April 2008
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility 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 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

Outcomes

Primary Outcomes

Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.

Time Frame: baseline, 120, 240 and 365 day follow-up

Secondary Outcomes

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

Study Sites (1)

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