Family Help Program: Nighttime Enuresis Treatment Program
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 Enuresis diagnoses. This is a single-centre trial based at the IWK Health Centre. The primary outcome is change in diagnosis.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Enuresis)|
- Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
- Symptomology frequency as evidenced by diary data; [ Time Frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization ] [ Designated as safety issue: No ]
- Disability Measure; [ Time Frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
- Child Health Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
- Economic Outcome assessment [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
|Study Start Date:||June 2003|
|Study Completion Date:||April 2008|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
FHP Night time Enuresis intervention
Behavioral: FHP Night time ENuresis Intervention
Urine alarm/evidence-based psychological Intervention
No Intervention: Control
To receive standard/usual care for Nocturnal Enuresis- No FHP Night time Enuresis INtervention
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270621
|Canada, Nova Scotia|
|IWK Health Centre|
|Halifax, Nova Scotia, Canada, B3K 6R8|
|Principal Investigator:||Patrick J. McGrath, PhD.||IWK Health Centre|