Trials / Enrolling By Invitation

Enrolling By InvitationNCT07393893

The Effects and Mechanism of Parent Intervention for Autism Sprectrum Disorder

The Effects of Parent-based IMPACT Intervention for Autism Sprectrum Disorder and Its Related Neural Mechanism

Status: Enrolling By Invitation
Phase: N/A
Study type: Interventional
Enrollment: 80 (estimated)

Sponsor: University of Electronic Science and Technology of China · Academic / Other
Sex: All
Age: 18 Months – 78 Months
Healthy volunteers: Not accepted

Summary

Detailed description

Purpose of the Research: The goal of this clinical study is to investigate if a parent training program called "Project IMPACT" (Improving Parents as Communication Teachers) can help improve the core challenges in social interaction and communication for children with Autism Spectrum Disorder (ASD). And to explore whether and how this intervention affects children's brain activity. We will use safe brain imaging techniques (such as MRI and functional Near-Infrared Spectroscopy, fNIRS) to compare changes in the brain before and after the intervention, aiming to understand the potential brain mechanisms behind behavioral progress. Ultimately, we hope to identify which types of children might benefit most from this intervention, providing insights for more personalized treatment recommendations in the future. Key Questions This Study Aims to Answer: Does participation in the IMPACT parent training program significantly improve ASD symptoms, social communication abilities, and adaptive functioning in daily life for children with ASD compared to general intervention? Study Design: This is a assessor blinding randomized controlled trial. Participating children will be randomly assigned to one of two groups: IMPACT Intervention Group (approximately 40 children): The primary caregivers of these children will receive a systematic IMPACT training course over about 10 weeks (including group sessions and individual coaching), learning how to apply these techniques during interactions at home. All caregiver will be encouraged to conduct intervention at least 10 hours per week. Control Group (approximately 40 children): The caregivers of these children will not receive IMPACT training during the initial 10-week period. They are encouraged to continue any current routine interventions their child is receiving. After 10 weeks, they will be offered the opportunity to receive the IMPACT training online for free as compensation. Intervention Component (Exclusively for families randomly assigned to the ImPACT group): Primary caregivers of participants will partake in the approximately 10 - week IMPACT parent training program. In weeks with odd numbers, caregivers will attend a group theory session lasting 3 - 4 hours. In weeks with even numbers, caregivers will receive a one - on - one coaching session (1 - 1.5 hours) with a trainer to enhance their intervention skills based on ImPACT. Caregivers are obligated to implement the learned strategies during daily home interactions with participants for a minimum of 10 hours per week and maintain a simple record of these activities. Trainers will monitor adherence via weekly reviews of activity logs and coaching sessions. Adherence will be further bolstered by real - time feedback during coaching sessions, where trainers prompt caregivers to engage their child in task - oriented activities while demonstrating and suggesting effective strategies, ensuring skill generalization in naturalistic settings. The research team will evaluate all children at three time points: before the intervention starts, immediately after the 10-week intervention period, and 6 months after the intervention ends. The assessors will not know which group each child belongs to (they will be "blinded") to ensure objective results. What the Involvement of Participation Entails: If your child (aged 1.5 to 6.5 years) has a diagnosis of ASD and you agree to participate, the following may be involved: Assessment Sessions (Three times: Pre-intervention, Post-intervention at 10 weeks, only SRS-2 measured after 6 months): Questionnaires: You will be asked to fill out questionnaires about your child's behavior, social skills, and your own experiences and stress levels. Child Assessments: A trained clinician, independent of the research team, will conduct standardized assessments of your child's development and social communication skills (e.g., ADOS-2, Griffiths Scales). Eye-Tracking Test: Your child will watch short videos while a specialized, non-invasive device records where and for how long your child looks. This helps us understand their visual attention preferences towards social information. Functional Near-Infrared Spectroscopy (fNIRS): During a play session, your child will wear a soft cap with sensors. It uses harmless near-infrared light to measure changes in brain activity in the outer layer of the brain. This procedure is safe, non-invasive, and radiation-free. Magnetic Resonance Imaging (MRI) Scan (voluntary): We plan to conduct one brain MRI scan before and after the intervention for all willing participants to study brain structure and function. To ensure the child remains still during the scan, we plan to perform it during natural, deep sleep. Voluntary Participation: Participation in this study is completely voluntary. You may decide to withdraw yourself and your child from the study at any time, for any reason, without any penalty or effect on the future medical care you receive at this hospital or elsewhere.This study will be submitted for ethical review to ensure it meets scientific and ethical standards, protecting the rights, safety, and well-being of every participant.

Conditions

Autism Spectrum Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Parents conducted interventions based on project ImPACT.	Parents conduct behavioral interventions under the supervision of professional trainers who have obtained the certificate of Project IMPACT training. They are encouraged to conduct the interventions at least 10 hours per week without receiving other interventions from institutions or hospitals. Parents are asked to record the activities and duration of intervention they conducted daily in a logbook, which is reviewed weekly by certified trainers to ensure fidelity and provide feedback. Adherence is monitored through every other week one-one session to review progress, address challenges, and refine strategies. Trainers emphasize consistent implementation of evidence-based techniques, ensuring parents maintain high fidelity to the ImPACT model.
BEHAVIORAL	General behavioral interventions	Children were subjected to interventions administered by behavioral trainers from hospitals or institutions. We advocated for them to persist with the existing interventions of any type (such as Applied Behavior Analysis, Discrete Trial Training, sensory integration, and language therapy) and augment the sessions to achieve a total of 10 hours per week, either in group or individual settings. Parents are asked to document the duration and type of sessions their children participated in each week in a notebook.

Timeline

Start date: 2024-10-08
Primary completion: 2026-07-01
Completion: 2026-12-01
First posted: 2026-02-06
Last updated: 2026-02-06

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT07393893. Inclusion in this directory is not an endorsement.