The Effects and Mechanism of Parent Intervention for Autism Sprectrum Disorder

Enrolling by invitation · Not applicable

Conditions studied: Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT07393893

Run by

University of Electronic Science and Technology of China

People needed

80

Starts

2024-10-08

Expected to finish

2026-12-01

Last updated by the study team

2026-02-06

Who can join

Age: 2 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Chengdu women's and children's central hospital — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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