Pediatric Recurrent Headache & Abdominal Pain Clinical Trial
Official title:
Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)
| Verified date | June 2015 |
| Source | IWK Health Centre |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Canada: Canadian Institutes of Health Research |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 10 |
| Est. completion date | April 2008 |
| Est. primary completion date | June 2007 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 9 Years to 12 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Canada | IWK Health Centre | Halifax | Nova Scotia |
| Lead Sponsor | Collaborator |
|---|---|
| IWK Health Centre | Canadian Institutes of Health Research (CIHR) |
Canada,
Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. — View 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. — View Citation
Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. — View 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. Review. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. | baseline, 120, 240 and 365 day follow-up | No | |
| Secondary | Symptomology frequency as evidenced by diary data; | daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization | No | |
| Secondary | Evaluated according to IHS criteria | baseline, 120, 240 and 365 day follow-up | No | |
| Secondary | Disability Measure; | weekly during treatment; baseline, 120, 240 and 365 day follow-up | No | |
| Secondary | Child Health Questionnaire | baseline, 120, 240 and 365 day follow-up | No | |
| Secondary | Economic Outcome assessment | baseline, 120, 240 and 365 day follow-up | No | |
| Secondary | Satisfaction measure, designed by the investigator | end of intervention | No |