Mother-Led Interactive Massage for Toddlers With Autism
Tests massage given by mothers to toddlers with autism spectrum disorder.
Plain-language title generated from the registry record
Registry title: Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder
Key facts
- Where
- Shanghai, ChinaSee the site
Where in China
- Children's Hospital Of Fudan UniversityShanghai, ChinaTaking people
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?
Trial details
- Who runs it
- Children's Hospital of Fudan University
- Trial code
- NCT07876245
- Record updated
- 15 October 2026
- Original description
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.Read full original descriptionShow less
Efficacy of Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder: A Randomized Controlled Trial
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.
Inclusion: 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: Receipt within the past 3 months of other interventions, including massage, acupuncture, or medications, that may affect neuroendocrine or brain function; Presence of other neurodevelopmental disorders, genetic or metabolic diseases, central nervous system infections, or organic lesions; Severe emotional or behavioral problems that prevent the child from cooperating with the massage intervention or study assessments.