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Mother-Led Interactive Massage for Toddlers With Autism

Tests massage given by mothers to toddlers with autism spectrum disorder.

Key facts

Who runs it
Children's Hospital of Fudan University
Where
Shanghai, ChinaSee the site
Trial code
Registry title
Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder
Status
Recruiting
People taking part
120 people, planned
Started
1 Sept 2025
Expected to end
30 Jun 2028
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Maternal Interactive Massage
  • Behavioral
Record updated
15 October 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 toddlers aged 18-24 months with autism spectrum disorder. Mothers give their child interactive massage for 3 months.

Age
18 to 24 months
Sex
Boys and girls can both join.
Disease stage
Autism spectrum disorder (DSM-5), confirmed by two senior developmental-behavioral pediatricians.
Earlier treatment
No massage, acupuncture or medicines that may affect hormones or brain function in the past 3 months.

Main reasons for not taking part

  • Other neurodevelopmental disorders, genetic or metabolic diseases, central nervous system infections or organic lesions
  • Severe motor, visual or hearing impairment
  • Severe emotional or behavioral problems that prevent taking part in the massage or assessments
  • Massage, acupuncture or medicines that may affect hormones or brain function in the past 3 months

The registry criteria, word for word

Show all 7 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in China

  • Children's Hospital Of Fudan UniversityShanghai, ChinaContact: Chunchun HuTaking people

About the trial

What the trial wants to find out

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

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.

The 2 groups in the trial

  • Interactive Massage + Usual CareTreatment being tested

    Participants assigned to the intervention group will receive standardized maternal interactive massage in addition to usual care and ASD parenting guidance for 3 months. Mothers will receive standardized training in massage techniques, including massage areas, intensity, duration, frequency, and safety procedures. The interactive massage will focus on the child's head and face, trunk, limbs, and palms and soles, primarily using gentle stroking, kneading, and pressing techniques. Mothers will perform the massage for 15 minutes per session, three sessions per day, six days per week, for 3 consecutive months. Intervention adherence will be monitored using daily intervention records, weekly online follow-up, and monthly in-person follow-up. Participants will continue to receive routine developmental and behavioral pediatric follow-up and ASD family parenting guidance during the intervention period.

    Treatment: Maternal Interactive Massage and Behavioral

  • Usual CareExisting treatment, for comparison

    Participants assigned to the usual care group will receive routine clinical follow-up and standardized ASD family parenting guidance for 3 months. Parenting guidance will include strategies related to social interaction skills and behavior management. Participants in this group will not receive interactive massage or massage-related training during the study period. After study completion, mothers in the usual care group will be offered interactive massage training.

    Treatment: Behavioral

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Efficacy of Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder: A Randomized Controlled Trial
Plain-language title
Mother-Led Interactive Massage for Toddlers With AutismGenerated 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
15 October 2026