Parent-led training to help children with autism communicate and interact socially
Tests a parent training program in young children with autism spectrum disorder.
Key facts
- Who runs it
- University of Electronic Science and Technology of China
- Where
- Chengdu, ChinaSee the site
- Trial code
- Registry title
- The Effects and Mechanism of Parent Intervention for Autism Sprectrum Disorder
- Status
- Enrolling by invitation
- People taking part
- 80 people, planned
- Started
- 8 Oct 2024
- Expected to end
- 1 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Parents conducted interventions based on project ImPACT.
- General behavioral interventions
- Record updated
- 6 February 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for young children with autism spectrum disorder. A parent must be able to take part in the whole parent training program and the assessments.
- Age
- 18 months to 78 months (6.5 years).
- Sex
- Boys and girls can both join.
- Disease stage
- A formal autism spectrum disorder diagnosis from a qualified clinician (DSM-5 or ICD-11), and an ADOS-2 score at or above the autism spectrum cutoff.
- Earlier treatment
- Children cannot currently use psychotropic medication. They cannot have had transcranial electrical or magnetic stimulation therapy within the last 3 months.
- Biomarker or test result
- An ADOS-2 score meeting the autism spectrum cutoff.
Main reasons for not taking part
- A major neurological disorder such as epilepsy or cerebral palsy, or a severe psychiatric condition
- A history of significant brain injury or trauma
- Current use of psychotropic medication
- Significant uncorrected problems with vision or hearing
- Motor function disorders
The registry criteria, word for word
Show all 9 criteriaShow less
Who can take part
- 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
Who cannot take part
- Current use of psychotropic medication or a within 3 months history of receiving transcranial electrical/magnetic stimulation therapy
- 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
Where in China
- Chengdu Women's and Children's Central HospitalChengdu, ChinaNo longer taking part
About the trial
What the trial wants to find out
Purpose of the Research:
Read full original descriptionShow less
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.
The 2 groups in the trial
- ImPACT-based InterventionsTreatment being tested
Parent-based behavioral interventions for children.
Treatment: Parents conducted interventions based on project ImPACT.
- General interventionsExisting treatment, for comparison
Current routine interventions provided by behavioral trainers.
Treatment: General behavioral interventions
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- The Effects of Parent-based IMPACT Intervention for Autism Sprectrum Disorder and Its Related Neural Mechanism
- Plain-language title
- Parent-led training to help children with autism communicate and interact sociallyGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 6 February 2026