The Effects and Mechanism of Parent Intervention for Autism Sprectrum Disorder

NCT07393893 | Enrolling By Invitation

• 1 other identifier: UESTC-neuSCAN-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Autism Spectrum Disorder

Keywords

AUTISM; PARENT INTERVENTION; MECHANISM

Outcome Measures

Primary Outcomes (4)

• Change in Autism Symptom Severity as measured by ADOS-2 Comparison Score and Subscales

  The ADOS-2 (Autism Diagnostic Observation Schedule, Second Edition) is a semi-structured, standardized assessment of communication, social interaction, play, and restricted and repetitive behaviors. The Comparison Score is a standardized metric used to compare autism severity across different modules and ages. The Comparison Score ranges from 1 to 10, with higher scores indicating greater severity of autism spectrum-related symptoms (worse outcome).

  From enrollment to the end of treatment at 10 weeks.

• Change in Social Impairment as measured by the Social Responsiveness Scale, Second Edition (SRS-2) Total Score

  The SRS-2 is a 65-item caregiver-completed rating scale that measures the severity of autism spectrum symptoms as they occur in natural social settings. Each item is scored on a 4-point Likert scale ranging from 0 (Never True) to 3 (Almost Always True). The Total Raw Score is calculated by summing the scores of all 65 items. The total raw score ranges from 0 to 195, with higher scores indicating greater severity of social impairment (worse outcome).

  From enrollment to the end of treatment at 10 weeks, 3months after treatment.

• Change in Child PFC Activation (Oxy-Hb) during Parent-Child Interaction

  Mean Oxygenated Hemoglobin (Oxy-Hb) concentration in the Prefrontal Cortex (PFC) collected while the child engages in a standardized play task with their parent. Higher concentration indicates greater activation.

  From enrollment to the end of treatment at 10 weeks.

• Change in Social Visual Preference Index (Percentage of Fixation Duration)

  Participants view a battery of 3 paired paradigms presenting simultaneous social and non-social stimuli. The index is calculated as the percentage of total fixation duration spent on Social Areas of Interest (AOIs) divided by the total fixation duration on both Social and Non-social AOIs. Formula: (Duration on Social / (Duration on Social + Duration on Non-social)) \* 100. The score is averaged across the 3 paradigms. Values range from 0 to 100%. Higher scores indicate a stronger preference for social stimuli.

  From enrollment to the end of treatment at 10 weeks.

Secondary Outcomes (13)

• Change in Adaptive Functioning as measured by the ABAS-II General Adaptive Composite (GAC) and Domain Scores

  From enrollment to the end of treatment at 10 weeks.

• Change in Structural Brain Volume (Gray Matter Volume) in Regions of Interest (e.g., Prefrontal Cortex, Amygdala

  From enrollment to the end of treatment at 10 weeks.

• Change in Caregiver Burden as measured by the Caregiver Strain Questionnaire (CSQ) Total Score

  From enrollment to the end of treatment at 10 weeks.

• Change in Parenting Sense of Competence (PSOC): Total Score and Subscales

  From enrollment to the end of treatment at 10 weeks.

• Change in Repetitive Behaviors as measured by the Repetitive Behavior Scale-Revised (RBS-R) Total Score

  From enrollment to the end of treatment at 10 weeks

Study Arms (2)

ImPACT-based Interventions

EXPERIMENTAL

Parent-based behavioral interventions for children.

Behavioral: Parents conducted interventions based on project ImPACT.

General interventions

ACTIVE COMPARATOR

Current routine interventions provided by behavioral trainers.

Behavioral: General behavioral interventions

Interventions

Parents conducted interventions based on project ImPACT. BEHAVIORAL

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.

Also known as: ImPACT

ImPACT-based Interventions

General behavioral interventions BEHAVIORAL

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.

General interventions

Eligibility Criteria

• Age: 18 Months - 78 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants must be between the ages of 18 months and 78 months (6.5 years) at the time of enrollment.
• Participants must have received a formal diagnosis of autism spectrum disorder (or meet criteria for conditions within the autism spectrum) from qualified clinicians, such as psychiatrists or pediatricians, in accordance with the diagnostic criteria specified in either the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) or the International Classification of Diseases, 11th Revision (ICD-11).
• Participants must have a score meeting the autism spectrum cutoff on the Autism Diagnostic Observation Schedule, Second Edition (ADOS-2).
• At least one parent is able to participate in the entire assessment and intervention procedure.

You may not qualify if:

• Presence of a comorbid major neurological disorder (e.g., epilepsy, cerebral palsy) or a severe psychiatric condition.
• A history of significant brain injury or trauma.
• Current use of psychotropic medication or a within 3 months history of receiving transcranial electrical/magnetic stimulation therapy.
• Significant uncorrected impairment in visual or auditory acuity.
• Motor function disorders.

Sponsors & Collaborators

• University of Electronic Science and Technology of China: lead

Study Sites (1)

Chengdu women's and children's central hospital

Chengdu, Sichuan, 610000, China

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Autistic Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate researcher

Study Record Dates

• First Submitted: December 10, 2025
• First Posted: February 6, 2026
• Study Start: October 8, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)