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Family Help Program: Nighttime Enuresis Treatment Program

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00270621
First received: December 23, 2005
Last updated: February 15, 2010
Last verified: February 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Enuresis
 Behavioral: FHP ENuresis
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Enuresis)

Resource links provided by NLM:

MedlinePlus related topics: Bedwetting
U.S. FDA Resources

Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Symptomology frequency as evidenced by diary data; [ Time Frame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization ] [ Designated as safety issue: No ]
  • Disability Measure; [ Time Frame: weekly during treatment; baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Child Health Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]
  • Economic Outcome assessment [ Time Frame: baseline, 120, 240 and 365 day follow-up ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: June 2003
Study Completion Date: April 2008
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
50% randomized to receive FHP distance intervention
 Behavioral: FHP ENuresis
Urine alarm/evidence-based psychological Intervention
No Intervention: Control
50% randomized to receive standard/usual care for Nocturnal Enuresis
 Behavioral: FHP ENuresis
Urine alarm/evidence-based psychological Intervention

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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00270621

Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Patrick J. McGrath, PhD. IWK Health Centre
  More Information

Additional Information:
Family Help Program  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Dr. Patrick McGrath, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00270621     History of Changes
Other Study ID Numbers: 2234e, CHIR CAHR-43273
Study First Received: December 23, 2005
Last Updated: February 15, 2010
Health Authority: Canada: Canadian Institutes of Health Research

Additional relevant MeSH terms:
Enuresis
Nocturnal Enuresis
Urination Disorders
Urologic Diseases
 Behavioral Symptoms
Elimination Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013