Family Help Program: Nighttime Enuresis Treatment Program

Phase 2

Completed

• Conditions: Enuresis
• Interventions: Behavioral: FHP Night time ENuresis Intervention

• Registration Number: NCT00270621
• Lead Sponsor: IWK Health Centre

Brief 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.

Study Timeline

• Study Start: 2003-06
• Study First Submitted: 2005-12-23
• Study First Submitted QC: 2005-12-23
• Study First Posted: 2005-12-28
• Primary Completion: 2006-10
• Study Completion: 2008-04
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-01
• Last Update Posted: 2016-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

• Is your child 3 to 12 years of age
• child wets the bed more than twice per week
• child dry during the day

Exclusion Criteria

• child received any treatment for bedwetting in the past 6 months
• child at any time been dry for 6 months or longer
• child currently on Imipramine or Desmopressin

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	FHP Night time ENuresis Intervention	FHP Night time Enuresis intervention

Primary Outcome Measures

Name	Time	Method
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.	baseline, 120, 240 and 365 day follow-up

Secondary Outcome Measures

Name	Time	Method
Symptomology frequency as evidenced by diary data;	daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
Child Health Questionnaire	baseline, 120, 240 and 365 day follow-up
Disability Measure;	weekly during treatment; baseline, 120, 240 and 365 day follow-up
Economic Outcome assessment	baseline, 120, 240 and 365 day follow-up

Trial Locations

Locations (1)

IWK Health Centre; 🇨🇦 Halifax, Nova Scotia, Canada