Strongest Families (Formerly Family Help Program):Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Disruptive Behaviour Disorder)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 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 Disruptive Behaviour symptomology. 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 Strongest Families (formerly 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 60 children (3-7 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric behavior disorder will be randomized.
The intervention is delivered from a distance, using 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 Strongest Families treated participants. It is anticipated that Strongest Families 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
- 3 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •child 3 to 7 years of age
- •child had behavioural problems for 6 months or longer
- •access to a telephone in the home
- •speak and write english
- •mild to moderate disruptive behaviour symptomology
排除标准
- •severe disruptive behaviour symptomology
- •received similar intervention within past 6 months
- •Autism or Schizophrenia
- •child has intellectual impairment
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
- Alabama Parenting Questionnaire(baseline, 120, 240 and 365 day follow-up)
- Revised Disruptive Disorder Rating Scale(baseline, 120, 240 and 365 day follow-up)
- Connors rating scale(baseline, 120, 240 and 365 day follow-up)
- 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)