Family Help Program: Pediatric Attention Deficit/Hyperactivity Disorder - Full Text View

Sponsors and Collaborators:	IWK Health Centre Canadian Institutes of Health Research (CIHR)
Information provided by:	IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00267605

Purpose

The purpose of the Family Help Program is to determine if Family Help distance intervention is as effective as usual or standard care 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	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:	Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Attention Deficit/Hyperactivity Disorder)

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
Treatment: Experimental 50% randomized to receive FHP behavioural distance intervention	Behavioral: FHPADHD Evidence-based psychological and behavioural distance intervention
Control: No Intervention 50% randomized to receive standard/usual care for ADHD	Behavioral: FHPADHD Evidence-based psychological and behavioural distance intervention

Detailed Description:

The purpose of the 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 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 Family Help treated participants. It is anticipated that Family Help 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

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

Family Help Program This link exits the ClinicalTrials.gov site

Publications:

Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9.

Responsible Party:	IWK Health Centre ( Dr. Patrick McGrath )
Study ID Numbers:	2234c, CHIR CAHR-43273
Study First Received:	December 19, 2005
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00267605
Health Authority:	Canada: Canadian Institutes of Health Research

Study placed in the following topic categories:

Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood

Neurologic Manifestations
Attention Deficit and Disruptive Behavior Disorders
Hyperkinesis
Dyskinesias

Additional relevant MeSH terms:

Pathologic Processes
Disease
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009