Clinical Trial: Family Help Program: Nighttime Enuresis Treatment Program

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: IWK Health Centre

Current Primary Outcome: Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up. [ Time Frame: baseline, 120, 240 and 365 day follow-up ]

Original Primary Outcome: Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.

Current Secondary Outcome:

  • Symptomology frequency as evidenced by diary data; [ Time Frame: 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 ]
  • Child Health Questionnaire [ Time Frame: baseline, 120, 240 and 365 day follow-up ]
  • Economic Outcome assessment [ Time Frame: baseline, 120, 240 and 365 day follow-up ]


Original Secondary Outcome:

  • Symptomology frequency as evidenced by diary data;
  • Disability Measure;
  • Child Health Questionnaire
  • Economic Outcome assessment
  • gathered at baseline, 120, 240 and 365 day follow-up.


Information By: IWK Health Centre

Dates:
Date Received: December 23, 2005
Date Started: June 2003
Date Completion:
Last Updated: September 1, 2016
Last Verified: September 2016