Family Help Program: Pediatric Recurrent Headache and Abdominal Pain

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 Recurrent Headache/Abdominal Pain symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.

Detailed Description
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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 106 children (9-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Recurrent Headache/Abdominal Pain 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.

Official Title
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Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)

Conditions
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Pediatric Recurrent Headache & Abdominal Pain

Intervention / Treatment
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* Behavioral: FHP Pain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: child 9 to 16 years of age child had recurrent headache and abdominal pain at least 3 times a month child's physical examination normal access to a telephone in the home speak and write english mild to moderate anxiety symptomology Exclusion Criteria: child's pain due to trauma, systemic disease or disorder child received any psychological treatment for this or similar disorder in the past 6 months

Ages Eligible for Study
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Minimum Age: 9 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% randomized to receive FHP Pain intervention | Behavioral: FHP Pain<br>* Evidence-based psychological and behavioural Intervention<br>|
| No Intervention: control<br>50% randomized to receive standard/usual care for recurrent headache/abdominal pain | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. |  | 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 | 
| Evaluated according to IHS criteria |  | 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 | 
| Satisfaction measure, designed by the investigator |  | end of intervention |