Clinical trial NCT00270621: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Enuresis
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2005-12-28
Enrollment: 56
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
timeFrame: baseline, 120, 240 and 365 day follow-up
Secondary outcomes:
measure: Symptomology frequency as evidenced by diary data;
timeFrame: daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization
measure: Disability Measure;
timeFrame: weekly during treatment; baseline, 120, 240 and 365 day follow-up
measure: Child Health Questionnaire
timeFrame: baseline, 120, 240 and 365 day follow-up
measure: Economic Outcome assessment
timeFrame: baseline, 120, 240 and 365 day follow-up
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Patrick J. McGrath, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.