Family Help Program: Pediatric Recurrent Headache and Abdominal Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00267618
Recruitment Status : Completed
First Posted : December 21, 2005
Last Update Posted : June 16, 2015
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
IWK Health Centre

Brief Summary:
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 or disease Intervention/treatment Phase
Pediatric Recurrent Headache & Abdominal Pain Behavioral: FHP Pain Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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)
Study Start Date : June 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. [ Time Frame: baseline, 120, 240 and 365 day follow-up ]

Secondary Outcome Measures :
  1. Symptomology frequency as evidenced by diary data; [ Time Frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization ]
  2. Evaluated according to IHS criteria [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
  3. Disability Measure; [ Time Frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up ]
  4. Child Health Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
  5. Economic Outcome assessment [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
  6. Satisfaction measure, designed by the investigator [ Time Frame: end of intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00267618

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