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Sponsors and Collaborators: |
IWK Health Centre Canadian Institutes of Health Research (CIHR) |
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Information provided by: | IWK Health Centre |
ClinicalTrials.gov Identifier: | NCT00270621 |
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 Enuresis symptomology. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.
Condition | Intervention | Phase |
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Enuresis |
Behavioral: FHP ENuresis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Enuresis) |
Enrollment: | 56 |
Study Start Date: | June 2003 |
Study Completion Date: | April 2008 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Treatment: Experimental
50% randomized to receive FHP distance intervention
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Behavioral: FHP ENuresis
Urine alarm/evidence-based psychological Intervention
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Control: No Intervention
50% randomized to receive standard/usual care for Nocturnal Enuresis
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Behavioral: FHP ENuresis
Urine alarm/evidence-based psychological Intervention
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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 46 children (5-12 years of age)suffering from pediatric enuresis (at least 2 times a week) will be randomized.
The intervention is delivered from a distance, using the urine alarm system accompanied by 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.
Ages Eligible for Study: | 5 Years to 12 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Canada, Nova Scotia | |
IWK Health Centre | |
Halifax, Nova Scotia, Canada, B3K 6R8 |
Principal Investigator: | Patrick J. McGrath, PhD. | IWK Health Centre |
Responsible Party: | IWK Health Centre ( Dr. Patrick McGrath ) |
Study ID Numbers: | 2234e, CHIR CAHR-43273 |
Study First Received: | December 23, 2005 |
Last Updated: | December 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00270621 |
Health Authority: | Canada: Canadian Institutes of Health Research |
Urologic Diseases Nocturnal Enuresis Mental Disorders Urination Disorders |
Enuresis Mental Disorders Diagnosed in Childhood Behavioral Symptoms |
Elimination Disorders |