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Family Help Program: Pediatric Recurrent Headache and Abdominal Pain

I

IWK Health Centre

Status and phase

Completed
Phase 2

Conditions

Pediatric Recurrent Headache & Abdominal Pain

Treatments

Behavioral: FHP Pain

Study type

Interventional

Funder types

Other

Identifiers

NCT00267618
2234d
CHIR CAHR-43273

Details and patient eligibility

About

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.

Full description

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.

Enrollment

10 patients

Sex

All

Ages

9 to 12 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

10 participants in 2 patient groups

Treatment
Experimental group
Description:
50% randomized to receive FHP Pain intervention
Treatment:
Behavioral: FHP Pain
control
No Intervention group
Description:
50% randomized to receive standard/usual care for recurrent headache/abdominal pain

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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