A Randomized Controlled Trial Evaluating an AI-Based Reflective Parenting Simulation for Parents of Autistic Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
- 主要终点
- Change in Study-Specific Parent Reflective Capacity Questionnaire Score
研究概览
简要总结
This randomized controlled trial evaluates an AI-based parental simulation designed to support reflective parenting, emotional regulation, and parent-child communication among parents of autistic children aged 3 to 12 years. A total of 140 parents will be recruited through an external online survey platform and randomly assigned to an intervention group or a control group. The intervention group will complete baseline questionnaires, engage with the AI-based simulation, and then complete post-intervention measures. The control group will complete baseline and post-assessment measures before receiving access to the simulation.
详细描述
The study examines the use of an AI-based parental simulation as a learning and reflective tool for parents of autistic children aged 3 to 12 years. The simulation is designed to allow parents to practice responses to emotionally challenging parent-child situations, with an emphasis on reflective functioning, emotional regulation, playfulness, and supportive parent-child communication.
Participants will be recruited through an external online survey platform and will provide informed consent before participation. After completing baseline questionnaires, participants will be randomly assigned to either an intervention group or a control group. Participants in the intervention group will complete the AI-based simulation and then complete post-intervention measures. Participants in the control group will complete post-assessment measures before receiving access to the simulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
盲法说明
No masking will be used. Participants and researchers will not know the group assignment before randomization; however, after assignment, participants will be aware of whether they complete the AI-based simulation before or after the post-assessment measures.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Parent or primary caregiver of an autistic child aged 3 to 12 years.
- •Child has a parent-reported diagnosis of Autism Spectrum Disorder.
- •Parent is 18 years of age or older.
- •Parent is able to read and complete questionnaires in Hebrew.
- •Parent has access to an internet-connected device and is able to complete the online study procedures.
- •Parent provides informed consent to participate.
排除标准
- •- Parent does not provide informed consent.
- •Parent is not the parent or primary caregiver of an autistic child aged 3 to 12 years.
- •Parent is unable to complete the online questionnaires or the AI-based reflective parenting simulation.
- •Duplicate, incomplete, or low-quality responses that do not meet study quality criteria.
研究组 & 干预措施
Control Group
Participants in this group will complete the baseline questionnaire battery, including a study-specific 8-item evaluation questionnaire assessing four targeted domains: knowledge and understanding, parent-child communication skills, shared emotional regulation, and relational security. They will then complete the same evaluation questionnaire again before receiving access to the AI-based therapeutic parental simulation. After using the simulation, they will complete user experience and human-machine interaction questionnaires.
Intervention Group
Participants in this group will complete the baseline questionnaire battery, including a study-specific 8-item evaluation questionnaire assessing four targeted domains: knowledge and understanding, parent-child communication skills, shared emotional regulation, and relational security. They will then engage with the AI-based therapeutic parental simulation and complete the same evaluation questionnaire again, followed by user experience and human-machine interaction questionnaires.
干预措施: AI-Based Reflective Parenting Simulation (Behavioral)
结局指标
主要结局
Change in Study-Specific Parent Reflective Capacity Questionnaire Score
时间窗: Baseline and immediately after the intervention or control assessment point
The study-specific Parent Reflective Capacity Questionnaire includes 8 items rated on a 1 to 5 scale. The questionnaire assesses parents' perceived capacity in four targeted domains: knowledge and understanding, parent-child communication skills, shared emotional regulation, and the parent-child relationship as a secure anchor. A total mean score will be calculated across the 8 items, with higher scores indicating higher perceived parental reflective capacity in the targeted domains.
次要结局
未报告次要终点