Family Help Program: Pediatric Recurrent Headache and Abdominal Pain

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00267618
First received: December 19, 2005
Last updated: February 15, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Pediatric Recurrent Headache & Abdominal Pain
Behavioral: FHP Pain
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 10
Study Start Date: June 2004
Study Completion Date: April 2008
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
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
Behavioral: FHP Pain
Evidence-based psychological and behavioural Intervention

Detailed 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.

  Eligibility

Ages Eligible for Study:   9 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00267618

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Patrick J. McGrath, PhD. IWK Health Centre
  More Information

Additional Information:
Publications:
Responsible Party: Dr. Patrick McGrath, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00267618     History of Changes
Other Study ID Numbers: 2234d, CHIR CAHR-43273
Study First Received: December 19, 2005
Last Updated: February 15, 2010
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Abdominal Pain
Headache
Nervous System Diseases
Neurologic Manifestations
Pain
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on October 30, 2014