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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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29 June 2015 |
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Main ID: |
NCT00267618 |
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Date of registration:
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19/12/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Family Help Program: Pediatric Recurrent Headache and Abdominal Pain
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Scientific title:
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Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain) |
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Date of first enrolment:
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June 2004 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00267618 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Canada
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Contacts
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Name:
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Patrick J. McGrath, PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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IWK Health Centre |
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Key inclusion & exclusion criteria
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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
Age minimum:
9 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pediatric Recurrent Headache & Abdominal Pain
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Intervention(s)
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Behavioral: FHP Pain
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Primary Outcome(s)
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Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
[Time Frame: baseline, 120, 240 and 365 day follow-up]
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Secondary Outcome(s)
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Evaluated according to IHS criteria
[Time Frame: baseline, 120, 240 and 365 day follow-up]
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Satisfaction measure, designed by the investigator
[Time Frame: end of intervention]
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Child Health Questionnaire
[Time Frame: baseline, 120, 240 and 365 day follow-up]
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Symptomology frequency as evidenced by diary data;
[Time Frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization]
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Disability Measure;
[Time Frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up]
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Economic Outcome assessment
[Time Frame: baseline, 120, 240 and 365 day follow-up]
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Secondary ID(s)
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CHIR CAHR-43273
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2234d
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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