Interactive massage for toddlers with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized study enrolls 120 toddlers aged 18-24 months with autism to test whether a standardized maternal interactive massage, added to usual ASD parenting guidance, improves the quality of parent-child interaction. The intervention involves the mother delivering 15 minutes of massage per session, three sessions daily, six days a week, for three months. Primary outcome is parent-child interaction quality; secondary outcomes include salivary oxytocin levels and brain responses to social versus non-social stimuli measured by fNIRS. Assessments occur at baseline and after the intervention period to evaluate behavioral, neuroendocrine, and neural effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18-24 months, regardless of sex.
* Meets the diagnostic criteria for autism spectrum disorder (ASD) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), with the diagnosis confirmed by two senior developmental-behavioral pediatricians.
* The caregiver is able to comply with the study assessments and intervention protocol and voluntarily provides written informed consent.
* No severe motor impairment or visual or hearing impairment, and the child is able to cooperate with saliva collection, functional near-infrared spectroscopy (fNIRS) assessment, and parent-child interaction assessment.

Exclusion Criteria:

* Presence of other neurodevelopmental disorders, genetic or metabolic diseases, central nervous system infections, or organic lesions.
* Receipt within the past 3 months of other interventions, including massage, acupuncture, or medications, that may affect neuroendocrine or brain function.
* Severe emotional or behavioral problems that prevent the child from cooperating with the massage intervention or study assessments.

Where it's running

• Children's Hospital of Fudan University
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Xiu Xu, Prof. — Children's Hospital of Fudan University
• Study coordinator: Bingrui Zhou, Dr.
• Email: zbr1800@163.com
• Phone: +86 13701989113

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.