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The Effects and Mechanism of Parent Intervention for Autism Sprectrum Disorder

NCT07393893 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-02-06

No results posted yet for this study

Summary

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.

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 with primary caregiver conducting intervention and Control Group with current routine interventions provided by behavioral trainers.

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 measurements include social - related questionnaires, ADOS - 2, Griffiths Scales, eye - tracking, task - based fNIRS, and fMRI without sedation.

Conditions

Interventions

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.

Sponsors & Collaborators

  • University of Electronic Science and Technology of China

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
78 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2026-07-01
Completion
2026-12-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07393893 on ClinicalTrials.gov