NCT07876245Recruiting
Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder
Efficacy of Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder: A Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 15 Oct 2026
Brief summary (registry, in English)
This randomized controlled trial aims to evaluate the efficacy of a 3-month maternal interactive massage intervention in toddlers aged 18-24 months with autism spectrum disorder (ASD). A total of 120 toddlers with ASD will be randomly assigned in a 1:1 ratio to either an intervention group or a usual care group. Participants in the intervention group will receive standardized maternal interactive massage in addition to usual care and ASD parenting guidance, whereas participants in the usual care group will receive usual care and ASD parenting guidance only. The interactive massage will be performed by the child's mother for 15 minutes per session, three sessions per day, six days per week, for three months. The primary outcome is parent-child interaction quality. Secondary outcomes include salivary oxytocin levels and brain responses to social versus non-social stimuli measured using functional near-infrared spectroscopy (fNIRS). Outcomes will be assessed at baseline, immediately after the 3-month intervention, and at a 1-month post-intervention follow-up.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 9 Oct 2026
- Start date
- 1 Sept 2025
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Children's Hospital of Fudan University
- Diseases
- Autism
- NCT number
- NCT07876245
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 1 Sept 2025 to the primary completion date, 30 Jun 2028
- 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
- Receipt within the past 3 months of other interventions, including massage, acupuncture, or medications, that may affect neuroendocrine or brain function.
Other illness
- Presence of other neurodevelopmental disorders, genetic or metabolic diseases, central nervous system infections, or organic lesions.
Other
- Severe emotional or behavioral problems that prevent the child from cooperating with the massage intervention or study assessments.
Who the study is looking for
- 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.
Age in the registry: 18 months to 24 months · Sex: All · Accepts 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 |
|---|---|---|---|
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.