Clinical Trials Directory

Trials / Completed

CompletedNCT00270621

Family Help Program: Nighttime Enuresis Treatment Program

Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Enuresis)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
56 (actual)
Sponsor
IWK Health Centre · Academic / Other
Sex
All
Age
5 Years – 12 Years
Healthy volunteers
Accepted

Summary

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.

Detailed 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 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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALFHP Night time ENuresis InterventionUrine alarm/evidence-based psychological Intervention

Timeline

Start date
2003-06-01
Primary completion
2006-10-01
Completion
2008-04-01
First posted
2005-12-28
Last updated
2016-09-02

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT00270621. Inclusion in this directory is not an endorsement.