Parent Feedback Intervention Study: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Brief Observation of Social Communication Change (BOSCC)
研究概览
简要总结
The purpose of this study is to use a randomized controlled trial to test the effectiveness of parent coaching sessions using video-based feedback, compared to the sessions without the use of video-based feedback on parent strategy use.
详细描述
This study is a randomized controlled trial of video-based feedback interventions for the parents of young children with autism spectrum disorder (ASD). In the beginning of the study, each participant will be randomized to the video-based feedback condition (treatment condition) or standard care procedure (control condition). All participants will be asked to implement the strategies taught during the sessions in the home environment (e.g., following the child's lead, sitting face-to-face). Participants randomized into the video-based feedback condition (treatment condition) will be asked to video-tape their interactions with their children (maximum 30 mins/week at home during free play, book reading, bath or meal time routines). The therapist then will review the tapes and then use the recorded sessions to give feedback on the parents' use of strategies in addition to providing in-vivo feedback based on the live interactions during the sessions. For parents whose children are randomized into the standard care condition, the families will receive coaching based on in-vivo sessions as described above. For all participants, a battery of assessment (diagnostic, developmental testing), will be administered at the beginning of the study participation, in the mid-point at 3 months, at the end of their 6-month participation of treatment sessions, and then at the follow-up period, 6 months after the end of their participation of the treatment sessions.
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
- 1 Year 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All children who will be enrolled into the early intervention (EI) classroom at the Center for Autism and the Developing Brain (CADB) will be invited to participate in the study.
排除标准
- •We do not have any exclusionary criteria as long as the children meet the inclusion criteria (families with children with ASD between 1-4 years who will be enrolling in the CADB early intervention classroom).
研究组 & 干预措施
Treatment Condition
This group will receive an additional component which will involve videotaping parent/child interactions at home for thirty minutes a week. Each week, the therapist will select sections of the video to review with the parent during one of the parent coaching sessions.
干预措施: Treatment Condition (Behavioral)
Control Group
This group will receive treatment as usual. Each participant will receive three hours of in-vivo parent coaching per week for 6 months.
干预措施: Control Group (Behavioral)
结局指标
主要结局
Change in Brief Observation of Social Communication Change (BOSCC)
时间窗: Baseline, months 1-6, and follow-up (12 months)
This is a brief, play-based assessment that aims to measure short-term changes in social communication. Scores range from 0 to 60 with higher scores indicating more ASD symptoms.
次要结局
- Change in Beck Depression Inventory(Baseline, post (6 months))
- Change in Autism Diagnostic Observation Schedule-2 (ADOS-2)(Baseline, post (6 months), follow-up (12 months))
- Change in Beck Anxiety Inventory(Baseline, post (6 months))
- Change in Parent Stress Index(Baseline, post (6 months))
- Change in Behavior Rating Inventory of Executive Function-Preschool Version(Baseline, post (6 months))