Clinical trial NCT00267618: Family Help Program: Pediatric Recurrent Headache and Abdominal Pain
Official title: Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pediatric Recurrent Headache & Abdominal Pain
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-12-21
Enrollment: 10
Sex: ALL
Minimum age (years): 9
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
timeFrame: baseline, 120, 240 and 365 day follow-up
Secondary outcomes:
measure: Symptomology frequency as evidenced by diary data;
timeFrame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
measure: Evaluated according to IHS criteria
timeFrame: baseline, 120, 240 and 365 day follow-up
measure: Disability Measure;
timeFrame: weekly during treatment; baseline, 120, 240 and 365 day follow-up
measure: Child Health Questionnaire
timeFrame: baseline, 120, 240 and 365 day follow-up
measure: Economic Outcome assessment
timeFrame: baseline, 120, 240 and 365 day follow-up
measure: Satisfaction measure, designed by the investigator
timeFrame: end of intervention
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Patrick J. McGrath, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.
citation: McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.
citation: Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.
citation: Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25.
citation: Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.