Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Enuresis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 2
- 主要终点
- Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Is your child 3 to 12 years of age
- •child wets the bed more than twice per week
- •child dry during the day
排除标准
- •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
结局指标
主要结局
Diagnosis using KSADS at baseline, 120, 240 and 365 day follow-up.
时间窗: baseline, 120, 240 and 365 day follow-up
次要结局
- Child Health Questionnaire(baseline, 120, 240 and 365 day follow-up)
- 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)
- Economic Outcome assessment(baseline, 120, 240 and 365 day follow-up)