Family Help Program: Pediatric Anxiety - Full Text View

Sponsor:	IWK Health Centre
Collaborator:	Canadian Institutes of Health Research (CIHR)
Information provided by:	IWK Health Centre
ClinicalTrials.gov Identifier:	NCT00267566

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 Anxiety symptomology. This is a single-center trial based at the IWK Health Center. The primary outcome is change in diagnosis.

Condition	Intervention	Phase
Anxiety Disorder	Behavioral: Family Help Anxiety Program	Phase II

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 Anxiety)

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

U.S. FDA Resources

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:

Diagnosis using KSADS [ Time Frame: baseline, 120, 240 and 365 day follow-up. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Symptomology frequency as evidenced by diary data; [ Time Frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization ] [ Designated as safety issue: No ]
Anxiety specific measure (MASC- self-report); [ 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:	91
Study Start Date:	August 2003
Study Completion Date:	April 2008
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment: Experimental 50% random assignment to receive Family Help Anxiety Treatment	Behavioral: Family Help Anxiety Program Evidence-based psychological and behavioural distance intervention
Control: Experimental 50% random assignment to control group to receive usual/standard care for anxiety	Behavioral: Family Help Anxiety Program 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 128 children (6-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric anxiety 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:	6 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

child 6 to 12 years of age
child had Anxiety symptoms for 6 months or longer
access to a telephone in the home
speak and write english
mild to moderate anxiety symptomology

Exclusion Criteria:

severe anxiety symptomology
received similar intervention within past 6 months
excessive anxiety following a significant traumatic event

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267566

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:

Family Help Program This link exits the ClinicalTrials.gov site

Publications:

Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40.

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

Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6.

Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66.

McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.

Responsible Party:	IWK Health Centre ( Dr. Patrick McGrath )
Study ID Numbers:	2234a, CIHR CAHR-43273
Study First Received:	December 19, 2005
Last Updated:	August 7, 2009
ClinicalTrials.gov Identifier:	NCT00267566 History of Changes
Health Authority:	Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:

Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on February 08, 2010