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Trial NCT00267618

Resource URI: http://static.linkedct.org/resource/trials/NCT00267618
PropertyValue
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/39042>
linkedct:arm_group <http://static.linkedct.org/resource/arm_group/63460>
linkedct:brief_title Family Help Program: Pediatric Recurrent Headache and Abdominal Pain
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/1060>
linkedct:condition <http://static.linkedct.org/resource/condition/16791>
linkedct: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
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers Accepts Healthy Volunteers
linkedct:eligibility_maximum_age 12 Years
linkedct:eligibility_minimum_age 9 Years
linkedct:end_date April 2008
linkedct:enrollment 10 (xsd:int)
linkedct:firstreceived_date December 19, 2005
linkedct:has_dmc No
linkedct:id NCT00267618
linkedct:intervention <http://static.linkedct.org/resource/intervention/84174>
rdfs:label Trial NCT00267618
linkedct:lastchanged_date August 7, 2009
linkedct:lead_sponsor_agency IWK Health Centre
linkedct:location <http://static.linkedct.org/resource/location/16651>
linkedct:nct_id NCT00267618
linkedct:number_of_arms 2 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)
linkedct:org_study_id 2234d
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/45461>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/402>
foaf:page <http://clinicaltrials.gov/show/NCT00267618>
linkedct:phase Phase 2
linkedct:primary_completion_date June 2007
linkedct:primary_outcomes <http://static.linkedct.org/resource/primary_outcomes/56214>
linkedct:reference <http://static.linkedct.org/resource/reference/33063>
linkedct:reference <http://static.linkedct.org/resource/reference/37317>
linkedct:secondary_id CHIR CAHR-43273
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/109101>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/26461>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/37108>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/40103>
linkedct:secondary_outcomes <http://static.linkedct.org/resource/secondary_outcomes/43714>
linkedct:source IWK Health Centre
linkedct:start_date June 2004
linkedct:study_design Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
linkedct:study_type Interventional
linkedct:summary The purpose of the Family Help Program is to determine if Family Help distance intervention is as effective as usual or standard care 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.
rdf:type linkedct:trials
linkedct:verification_date July 2009