Family Help Program: Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Recurrent Headache and Abdominal Pain)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 10
- 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 Recurrent Headache/Abdominal Pain 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 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 106 children (9-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric Recurrent Headache/Abdominal Pain 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 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
- 9 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •child 9 to 16 years of age
- •child had recurrent headache and abdominal pain at least 3 times a month
- •child's physical examination normal
- •access to a telephone in the home
- •speak and write english
- •mild to moderate anxiety symptomology
排除标准
- •child's pain due to trauma, systemic disease or disorder
- •child received any psychological treatment for this or similar disorder in the past 6 months
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
- Symptomology frequency as evidenced by diary data;(daily during treatment; 3 weeks on follow-up at 240 & 365 day post randomization)
- Evaluated according to IHS criteria(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)
- Satisfaction measure, designed by the investigator(end of intervention)