Family Help Program: Nighttime Enuresis Treatment Program

September 1, 2016 updated by: IWK Health Centre

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

56

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Time Frame: baseline, 120, 240 and 365 day follow-up
baseline, 120, 240 and 365 day follow-up

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Collaborators

Canadian Institutes of Health Research (CIHR)

Investigators

  • Principal Investigator: Patrick J. McGrath, PhD., IWK Health Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2003

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

April 1, 2008

Study Registration Dates

First Submitted

December 23, 2005

First Submitted That Met QC Criteria

December 23, 2005

First Posted (Estimate)

December 28, 2005

Study Record Updates

Last Update Posted (Estimate)

September 2, 2016

Last Update Submitted That Met QC Criteria

September 1, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2234e
  • CIHR CAHR-43273 (Other Grant/Funding Number: Canadian Institutes of Health Research (CIHR))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Aggregate summary data would be made available but not individual data.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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