Strongest Families (Formerly Family Help Program): Pediatric Anxiety

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety Disorder

Intervention / Treatment
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* Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>50% random assignment to receive Family Help Anxiety Treatment | Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program<br>* Evidence-based psychological and behavioural distance intervention<br>* Other names: Strongest Families (formerly Family Help Program);|
| Experimental: Control<br>50% random assignment to control group to receive usual/standard care for anxiety | Behavioral: Strongest Families (formerly Family Help Program): Anxiety Program<br>* Evidence-based psychological and behavioural distance intervention<br>* Other names: Strongest Families (formerly Family Help Program);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis using KSADS |  | baseline, 120, 240 and 365 day follow-up. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |