- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Yael Enav, PhD
- Numéro de téléphone: 972-507261474
- E-mail: yaelenav@edu.haifa.ac.il
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La 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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Dépistage
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Aucune 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Study-Specific Parent Reflective Capacity Questionnaire Score
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UH-129-26-ASD-AI
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .