Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  Purpose

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.


Condition Intervention Phase
Attention Deficit/Hyperactivity Disorder
Behavioral: FHPADHD
Behavioral: ADHD Standard Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Strongest Families (Formerly Family Help Program): Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Attention Deficit/Hyperactivity Disorder)

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 72
Study Start Date: June 2003
Study Completion Date: April 2008
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
FHPADHD 50% randomized to receive Strongest Families (formerly Family Help Program): behavioural distance intervention
Behavioral: FHPADHD
Evidence-based psychological and behavioural distance intervention
Other Name: Strongest Families (formerly Family Help Program):
Active Comparator: Control
ADHD Standard Care 50% randomized to receive standard/usual care for ADHD
Behavioral: ADHD Standard Care

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.

  Eligibility

Ages Eligible for Study:   8 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267605

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Patrick J. McGrath, PhD. IWK Health Centre
  More Information

Additional Information:
Publications:
Responsible Party: IWK Health Centre
ClinicalTrials.gov Identifier: NCT00267605     History of Changes
Other Study ID Numbers: 2234c, CHIR CAHR-43273
Study First Received: December 19, 2005
Last Updated: March 27, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Disease
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Dyskinesias
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms

ClinicalTrials.gov processed this record on November 20, 2014