Pilot Study of JASPER in Down Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Joint Engagement
研究概览
简要总结
The goal of this study is to determine whether JASPER (Joint Attention, Symbolic Play, Engagement, Regulation), which is an intensive, targeted early behavioral intervention focused on a developmentally based approach for teaching joint engagement, joint attention, and play skills can improve behavioral / emotional regulation, social communication skills, and developmental trajectories in Down syndrome (DS). The investigators will also explore the potential use of EEG and event-related potentials (ERP) as outcome measures, as this approach may help elucidate mechanisms of change in behavior and development, and may help explain differences in development of social communication skills in individuals with DS. EEG and ERP measure may also help to predict treatment outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 24 Months 至 48 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of Trisomy 21
- •Age 24-48 months
- •Able to walk independently across a room
- •Uses at least 5 words / signs
- •English speaking
- •Parent able to accompany participant to all study visits
排除标准
- •Diagnosis of Mosaic / Translocation Down syndrome
结局指标
主要结局
Change in Joint Engagement
时间窗: Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months)
Joint engagement will be measured by coded videos of the Caregiver Child Interaction (CCX) session. CCX measures the amount of time that parent and child engage during a play session.
次要结局
- Change in joint attention skills(Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months))
- Change in social-communication skills (part a)(Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months))
- Change in language, socialization, problem behavior, adaptive skills (part a)(Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months))
- Change in social-communication skills (part b)(Administered at baseline assessment #1 (0 months) and assessment visit #3 (6 months))
- Change in cognition(Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months))
- Change in language, socialization, problem behavior, adaptive skills (part b)(Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months))
- Change in play levels(Administered at baseline assessment #1 (0 months), assessment visit #2 (3 months), and assessment visit #3 (6 months))
研究者
Nicole Baumer
Principle Investigator
Boston Children's Hospital