NCT07687381

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
11mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Jul 2027

First Submitted

Initial submission to the registry

June 30, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

June 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

July 8, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 30, 2026

Last Update Submit

July 7, 2026

Conditions

Keywords

Parents of Autistic ChildrenReflective ParentingParental Self-EfficacyEmotion RegulationParent-Child CommunicationAI-Based Simulation

Outcome Measures

Primary Outcomes (1)

  • Change in Study-Specific Parent Reflective Capacity Questionnaire Score

    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

Study Arms (2)

Intervention Group

EXPERIMENTAL

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.

Behavioral: AI-Based Reflective Parenting Simulation

Control Group

NO INTERVENTION

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.

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Autism Spectrum DisorderEmotional Regulation

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
SCREENING
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either an intervention group or a control group. The intervention group will complete baseline questionnaires, engage with the AI-based therapeutic parental simulation, and then complete post-intervention measures. The control group will complete baseline and post-assessment measures before receiving access to the simulation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2026

First Posted

July 7, 2026

Study Start

June 30, 2026

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

July 8, 2026

Record last verified: 2026-06