Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder

NCT07876245 | Recruiting

• 1 other identifier: IMI-ASD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Autism

Keywords

Autism Spectrum Disorder; Interactive Massage; Early Intervention; Parent-Child Interaction; Oxytocin; fNIRS

Outcome Measures

Primary Outcomes (1)

• Parent-child interaction quality

  Parent-child interaction quality will be assessed using the Early Parent-Child Interaction Questionnaire (EPIQ) combined with video-based behavioral coding. During each assessment, the mother and child will participate in a standardized 10-minute free-interaction session in a laboratory setting with age-appropriate toys, such as building blocks, picture books, and dolls. The interaction will be video-recorded and evaluated using EPIQ scores and quantitative coding of parent-child interaction behaviors. Video coding will be conducted by two independent raters blinded to group assignment.

  Baseline, immediately after the 3-month intervention, and 1 month after completion of the intervention

Study Arms (2)

Interactive Massage + Usual Care

EXPERIMENTAL

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.

Behavioral: Maternal Interactive Massage; Behavioral: Behavioral

Usual Care

ACTIVE COMPARATOR

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.

Behavioral: Behavioral

Interventions

Maternal Interactive Massage BEHAVIORAL

Mothers of participants assigned to the intervention group will receive standardized training in interactive massage, including massage techniques, body areas, intensity, duration, frequency, and safety procedures. Training will include instructional videos and hands-on practice to ensure that mothers can independently and correctly perform the intervention. 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. Weekly online follow-up and monthly in-person follow-up will be conducted to assess adherence and provide retraining or individualized guidance when needed. An intervention adherence rate of at least

Interactive Massage + Usual Care

Behavioral BEHAVIORAL

Participants will receive routine developmental and behavioral pediatric follow-up and standardized ASD family parenting guidance for 3 months. Parenting guidance will include strategies related to social interaction skills and behavior management. No interactive massage or massage-related training will be provided to participants in the usual care group during the study period.

Also known as: Usual Care and ASD Parenting Guidance

Interactive Massage + Usual Care; Usual Care

Eligibility Criteria

• Age: 18 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

RECRUITING

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Xiu Xu, Prof.

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingrui Zhou, Dr.

CONTACT

+86 13701989113; zbr1800@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2026
• First Posted: October 15, 2026
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: October 15, 2026

Record last verified: 2026-10

Locations

CN (1)