Anxiety Disorder
Conditions
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.
Interventions
BEHAVIORALStrongest Families (formerly Family Help Program): Anxiety Program
Evidence-based psychological and behavioural distance intervention
Sponsors
Canadian Institutes of Health Research (CIHR)
IWK Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnosis using KSADS | baseline, 120, 240 and 365 day follow-up. |
Secondary
| Measure | Time frame |
|---|---|
| Symptomology frequency as evidenced by diary data; | daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization |
| Anxiety specific measure (MASC- self-report); | baseline, 120, 240 and 365 day follow-up |
| Disability Measure; | weekly during treatment; baseline, 120, 240 and 365 day follow-up |
| Child Health Questionnaire | baseline, 120, 240 and 365 day follow-up |
| Economic Outcome assessment | baseline, 120, 240 and 365 day follow-up |
Countries
Canada
Outcome results
None listed