- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07687381
AI-Based Reflective Parenting Simulation for Parents of Autistic Children
A Randomized Controlled Trial Evaluating an AI-Based Reflective Parenting Simulation for Parents of Autistic Children
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yael Enav, PhD
- Phone Number: 972-507261474
- Email: yaelenav@edu.haifa.ac.il
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- - 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.
Exclusion Criteria:
- - 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
An AI-based reflective parenting simulation designed for parents of autistic children aged 3 to 12 years.
The simulation allows parents to practice reflective, emotionally regulated, and supportive responses to challenging parent-child situations, with an emphasis on parent-child communication, shared emotional regulation, and the parent-child relationship as a secure anchor.
|
|
No Intervention: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Study-Specific Parent Reflective Capacity Questionnaire Score
Time Frame: 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.
|
Baseline and immediately after the intervention or control assessment point
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UH-129-26-ASD-AI
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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