NCT07393893Enrolling by invitation
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
Source: ClinicalTrials.gov · Last updated 6 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 80 (estimated)
- First submitted
- 10 Dec 2025
- Start date
- 8 Oct 2024
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- University of Electronic Science and Technology of China
- Diseases
- Autism
- NCT number
- NCT07393893
What you commit to
- Study type: Interventional
- Planned participants: 80
- From 8 Oct 2024 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current use of psychotropic medication or a within 3 months history of receiving transcranial electrical/magnetic stimulation therapy.
Other illness
- 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.
- Significant uncorrected impairment in visual or auditory acuity.
- Motor function disorders.
Who the study is looking for
- 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.
Age in the registry: 18 months to 78 months · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chengdu Women's and Children's Central Hospital Coordinator of this site? Confirm its status | Chengdu | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.