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临床试验/NCT00164307
NCT00164307已完成1 期

Assisting Children With Prenatal Alcohol Exposure in Developing Peer Friendships

Centers for Disease Control and Prevention2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2001年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
100
试验地点
2
主要终点
peer relationships/friendships

研究概览

简要总结

Children will be randomly assigned to a Parent-assisted social skills training or Wait list. Baseline and post intervention rating will be obtained from teachers.

详细描述

Targeted Area of Intervention: Social skills and development of best friend relationships. The specific intervention will be twelve small group sessions (90 minutes each) over a 6-week period. Child sessions consist of 4 components: 1) children report on homework assignments; 2) didactic presentation, behavioral rehearsal, and coaching, 3) coached play, and 4) new homework activities assigned with parent. Topics to be addressed across sessions include: reduction of maladaptive behaviors, information exchange techniques, places and times to make friends, group acceptance, praising other children, negotiation, play dates, dealing with teasing, and winner/loser skills. At the start of the intervention, parent and children will work with staff to develop a list of social skills, behaviors, and goals that they would like targeted for each child.

Parent component: Kathleen Mitchell (NOFAS) is an investigator to provide parent input to the study. Parent-only sessions will instruct them on key features being taught to their child. Concurrent parent sessions will include: 1) education on FAS/ARND, 2) parents present specific issues with their child, 3) review of current child session objectives and techniques, 4) new homework activities developed, 5) parent and child together review homework.

Evaluation Plan: Treatment and control (WL) groups will be compared using pre- and post-tests measures. Post-tests will be at the conclusion of the intervention and at a 4-month follow-up. Baseline parent measures include Social Skills Rating Scale, FAS Behavior Scale, and Test of Advocacy Knowledge. Baseline child measures include knowledge of social skills. Process (e.g., homework completion, attendance, etc) and outcome (e.g., social skills ratings, progress towards individual goals) measures will be evaluated.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Ect
盲法
Single

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children ages 6 to 8 years
  • history of prenatal alcohol exposure

排除标准

  • non english speaking

结局指标

主要结局

peer relationships/friendships

social skills

次要结局

未报告次要终点

研究者

研究点 (2)

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