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Family Help Program: Pediatric Anxiety

Information source: IWK Health Centre
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anxiety Disorder

Intervention: Family Help Anxiety Program (Behavioral)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: IWK Health Centre

Official(s) and/or principal investigator(s):
Patrick J McGrath, PhD., Principal Investigator, Affiliation: IWK Health Centre

Summary

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.

Clinical Details

Official title: Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Anxiety)

Study design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Diagnosis using KSADS

Secondary outcome:

Symptomology frequency as evidenced by diary data;

Anxiety specific measure (MASC- self-report);

Disability Measure;

Child Health Questionnaire

Economic Outcome assessment

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

Minimum age: 6 Years. Maximum age: 12 Years. Gender(s): Both.

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

Locations and Contacts

IWK Health Centre, Halifax, Nova Scotia B3K 6R8, Canada
Additional Information

Related publications:

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

Starting date: August 2003
Ending date: April 2008
Last updated: November 27, 2007

Page last updated: June 20, 2008

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