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Family Help Program: Nighttime Enuresis Treatment Program

Primary Purpose

Enuresis

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
FHP Night time ENuresis Intervention
Sponsored by
IWK Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Enuresis

Eligibility Criteria

5 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • IWK Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment

Control

Arm Description

FHP Night time Enuresis intervention

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Symptomology frequency as evidenced by diary data;
Disability Measure;
Child Health Questionnaire
Economic Outcome assessment

Full Information

First Posted
December 23, 2005
Last Updated
September 1, 2016
Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00270621
Brief Title
Family Help Program: Nighttime Enuresis Treatment Program
Official Title
Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Enuresis)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IWK Health Centre
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Enuresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
FHP Night time Enuresis intervention
Arm Title
Control
Arm Type
No Intervention
Arm Description
To receive standard/usual care for Nocturnal Enuresis- No FHP Night time Enuresis INtervention
Intervention Type
Behavioral
Intervention Name(s)
FHP Night time ENuresis Intervention
Intervention Description
Urine alarm/evidence-based psychological Intervention
Primary Outcome Measure Information:
Title
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
Time Frame
baseline, 120, 240 and 365 day follow-up
Secondary Outcome Measure Information:
Title
Symptomology frequency as evidenced by diary data;
Time Frame
daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
Title
Disability Measure;
Time Frame
weekly during treatment; baseline, 120, 240 and 365 day follow-up
Title
Child Health Questionnaire
Time Frame
baseline, 120, 240 and 365 day follow-up
Title
Economic Outcome assessment
Time Frame
baseline, 120, 240 and 365 day follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick J. McGrath, PhD.
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Aggregate summary data would be made available but not individual data.
Citations:
PubMed Identifier
18632997
Citation
Lingley-Pottie P, McGrath PJ. A paediatric therapeutic alliance occurs with distance intervention. J Telemed Telecare. 2008;14(5):236-40. doi: 10.1258/jtt.2008.080101.
Results Reference
background
PubMed Identifier
18632994
Citation
Lingley-Pottie P, McGrath PJ. Telehealth: a child and family-friendly approach to mental health-care reform. J Telemed Telecare. 2008;14(5):225-6. doi: 10.1258/jtt.2008.008001.
Results Reference
background
PubMed Identifier
19270846
Citation
McGrath PJ, Lingley-Pottie P, Emberly DJ, Thurston C, McLean C. Integrated knowledge translation in mental health: family help as an example. J Can Acad Child Adolesc Psychiatry. 2009 Feb;18(1):30-7.
Results Reference
background
PubMed Identifier
17227604
Citation
Lingely-Pottie P, McGrath PJ. A therapeutic alliance can exist without face-to-face contact. J Telemed Telecare. 2006;12(8):396-9. doi: 10.1258/135763306779378690.
Results Reference
result
PubMed Identifier
18025870
Citation
Lingley-Pottie P, McGrath PJ. Distance therapeutic alliance: the participant's experience. ANS Adv Nurs Sci. 2007 Oct-Dec;30(4):353-66. doi: 10.1097/01.ANS.0000300184.94595.25.
Results Reference
result
PubMed Identifier
32364251
Citation
Caldwell PH, Codarini M, Stewart F, Hahn D, Sureshkumar P. Alarm interventions for nocturnal enuresis in children. Cochrane Database Syst Rev. 2020 May 4;5(5):CD002911. doi: 10.1002/14651858.CD002911.pub3.
Results Reference
derived
Links:
URL
http://www.bringinghealthhome.com/
Description
Family Help Program

Learn more about this trial

Family Help Program: Nighttime Enuresis Treatment Program

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