Strongest Families (Formerly Family Help Program): Pediatric Anxiety
- Conditions
- Anxiety Disorder
- Registration Number
- NCT00267566
- Lead Sponsor
- IWK Health Centre
- Brief Summary
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 Anxiety symptomology. This is a single-center trial based at the IWK Health Center. The primary outcome is change in diagnosis.
- 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 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 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 Family Help treated participants. It is anticipated that Family Help treatment will be proven to be as or more effective than standard care.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 91
- 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
- severe anxiety symptomology
- received similar intervention within past 6 months
- excessive anxiety following a significant traumatic event
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Diagnosis using KSADS baseline, 120, 240 and 365 day follow-up.
- Secondary Outcome Measures
Name Time Method Anxiety specific measure (MASC- self-report); baseline, 120, 240 and 365 day follow-up Economic Outcome assessment baseline, 120, 240 and 365 day follow-up Symptomology frequency as evidenced by diary data; daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization Child Health Questionnaire baseline, 120, 240 and 365 day follow-up Disability Measure; weekly during treatment; baseline, 120, 240 and 365 day follow-up
Trial Locations
- Locations (1)
IWK Health Centre
🇨🇦Halifax, Nova Scotia, Canada