Family Help Program: Pediatric Recurrent Headache and Abdominal Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2008-04-30

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.

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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.

Conditions

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Pediatric Recurrent Headache & Abdominal Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

50% randomized to receive FHP Pain intervention

Group Type EXPERIMENTAL

FHP Pain

Intervention Type BEHAVIORAL

Evidence-based psychological and behavioural Intervention

control

50% randomized to receive standard/usual care for recurrent headache/abdominal pain

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FHP Pain

Evidence-based psychological and behavioural Intervention

Intervention Type BEHAVIORAL

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

Minimum Eligible Age

9 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes