- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Yael Enav, PhD
- 전화번호: 972-507261474
- 이메일: yaelenav@edu.haifa.ac.il
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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.
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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.
|
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간섭 없음: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Change in Study-Specific Parent Reflective Capacity Questionnaire Score
기간: 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.
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Baseline and immediately after the intervention or control assessment point
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- UH-129-26-ASD-AI
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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