Family Help Program: Pediatric Recurrent Headache and Abdominal Pain
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.
Pediatric Recurrent Headache & Abdominal Pain
Behavioral: FHP Pain
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)|
- Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
- Symptomology frequency as evidenced by diary data; [ Time Frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization ] [ Designated as safety issue: No ]
- Evaluated according to IHS criteria [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
- Disability Measure; [ Time Frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
- Child Health Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
- Economic Outcome assessment [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
- Satisfaction measure, designed by the investigator [ Time Frame: end of intervention ] [ Designated as safety issue: No ]
|Study Start Date:||June 2004|
|Study Completion Date:||April 2008|
|Primary Completion Date:||June 2007 (Final data collection date for primary outcome measure)|
50% randomized to receive FHP Pain intervention
Behavioral: FHP Pain
Evidence-based psychological and behavioural Intervention
No Intervention: control
50% randomized to receive standard/usual care for recurrent headache/abdominal pain
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00267618
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Principal Investigator:||Patrick J. McGrath, PhD.||IWK Health Centre|