Family Help Program: Nighttime Enuresis Treatment Program

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2008-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Enuresis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment

FHP Night time Enuresis intervention

Group Type EXPERIMENTAL

FHP Night time ENuresis Intervention

Intervention Type BEHAVIORAL

Urine alarm/evidence-based psychological Intervention

Control

To receive standard/usual care for Nocturnal Enuresis- No FHP Night time Enuresis INtervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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FHP Night time ENuresis Intervention

Urine alarm/evidence-based psychological Intervention

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes