Family Help Program: Nighttime Enuresis Treatment Program

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Enuresis

Intervention / Treatment
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* Behavioral: FHP Night time ENuresis Intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>FHP Night time Enuresis intervention | Behavioral: FHP Night time ENuresis Intervention<br>* Urine alarm/evidence-based psychological Intervention<br>|
| No Intervention: Control<br>To receive standard/usual care for Nocturnal Enuresis- No FHP Night time Enuresis INtervention | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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