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

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.

Study Type: Interventional

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

Study Primary Completion Date: September 2007

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.

Intervention(s) in this Clinical Trial

• Behavioral: Family Help Anxiety Program
  • Evidence-based psychological and behavioural distance intervention

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Treatment
  • 50% random assignment to receive Family Help Anxiety Treatment
• Experimental: Control
  • 50% random assignment to control group to receive usual/standard care for anxiety

Primary Measures

• Diagnosis using KSADS
  • Time Frame: baseline, 120, 240 and 365 day follow-up.
    Safety Issue?: No

Secondary Measures

• Symptomology frequency as evidenced by diary data;
  • Time Frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
    Safety Issue?: No
• Anxiety specific measure (MASC- self-report);
  • Time Frame: baseline, 120, 240 and 365 day follow-up
    Safety Issue?: No
• Disability Measure;
  • Time Frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up
    Safety Issue?: No
• Child Health Questionnaire
  • Time Frame: baseline, 120, 240 and 365 day follow-up
    Safety Issue?: No
• Economic Outcome assessment
  • Time Frame: baseline, 120, 240 and 365 day follow-up
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 12 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: IWK Health Centre

Overall Clinical Trial Officials and Contacts

Patrick J McGrath, PhD. Principal Investigator IWK Health Centre  

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00267566

Study ID Number: 2234a

ClinicalTrials.gov Identifier: NCT00267566

Health Authority: Canada: Canadian Institutes of Health Research

Family Help Program