Strongest Families (Formerly Family Help Program): Primary Care Delivery by Telephone for Psychological and Behavioural Problems (Pediatric Anxiety)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Diagnosis using KSADS
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 Anxiety symptomology. This is a single-center trial based at the IWK Health Center. 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 128 children (6-12 years of age)suffering from mild to moderate (but clinically significant) symptoms of pediatric anxiety 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 Strongest Families (formerly 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
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •child 6 to 12 years of age
- •child had Anxiety symptoms for 6 months or longer
- •access to a telephone in the home
- •speak and write english
- •mild to moderate anxiety symptomology
排除标准
- •severe anxiety symptomology
- •received similar intervention within past 6 months
- •excessive anxiety following a significant traumatic event
研究组 & 干预措施
Control
50% random assignment to control group to receive usual/standard care for anxiety
干预措施: Strongest Families (formerly Family Help Program): Anxiety Program (Behavioral)
Treatment
50% random assignment to receive Family Help Anxiety Treatment
干预措施: Strongest Families (formerly Family Help Program): Anxiety Program (Behavioral)
结局指标
主要结局
Diagnosis using KSADS
时间窗: baseline, 120, 240 and 365 day follow-up.
次要结局
- Anxiety specific measure (MASC- self-report);(baseline, 120, 240 and 365 day follow-up)
- Economic Outcome assessment(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)
- Child Health Questionnaire(baseline, 120, 240 and 365 day follow-up)
- Disability Measure;(weekly during treatment; baseline, 120, 240 and 365 day follow-up)