AutismIMI-ASDNCT07876245
Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder
A study testing Maternal Interactive Massage and Behavioral in people with Autism, run by Children's Hospital of Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Autism
- What is being tested?
- Maternal Interactive Massage and Behavioral
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2025to 30 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, 201102
Chunchun Hu, +86 13701989113, 14211240007@fudan.edu.cn
Xiu Xu, Prof.
About this study
Official title: 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.
Read the detailed description
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by impairments in social communication and the presence of restricted and repetitive behaviors and interests. Early childhood represents an important period for intervention because of rapid neurodevelopment and neural plasticity. However, many existing interventions for ASD can be difficult to implement consistently in family settings because they require substantial professional resources, time, and financial costs. Interactive massage is a convenient, low-cost, family-based non-pharmacological intervention that may support early development by providing tactile and sensory stimulation while promoting parent-child interaction.
Oxytocin plays an important role in social cognition, emotion recognition, and interpersonal bonding and has been associated with social communication abilities in children with ASD. Altered neural responses and functional connectivity in brain regions involved in social cognition have also been reported in ASD. Functional near-infrared spectroscopy (fNIRS) provides a non-invasive and motion-tolerant method for assessing cortical responses in young children. In addition, the quality of early parent-child interaction is an important environmental factor associated with the development of children's social abilities. However, the effects of interactive massage on behavioral, neuroendocrine, and neural outcomes in toddlers with ASD remain insufficiently understood.
This study is a randomized controlled trial designed to evaluate the efficacy of a standardized maternal interactive massage intervention in toddlers aged 18-24 months with ASD. A total of 120 eligible participants will be randomly assigned in a 1:1 ratio to an intervention group or a usual care group.
Mothers of children assigned to the intervention group will receive standardized training in interactive massage techniques, including massage areas, intensity, duration, frequency, and safety procedures. The massage will focus on the head and face, trunk, limbs, and palms and soles and will primarily involve gentle stroking, kneading, and pressing. Mothers will perform the massage for 15 minutes per session, three sessions per day, six days per week, for three consecutive months. The intervention group will also receive usual clinical care and ASD family parenting guidance. Intervention adherence will be monitored through daily records, weekly online follow-up, and monthly in-person follow-up.
Participants assigned to the usual care group will receive routine clinical follow-up and standardized ASD parenting guidance for three months without massage or related massage training during the study period. Mothers in this group will be offered interactive massage training after study completion.
Assessments will be conducted at baseline, immediately after completion of the 3-month intervention, and at a 1-month post-intervention follow-up. The primary outcome is parent-child interaction quality, assessed using the Early Parent-Child Interaction Questionnaire (EPIQ) together with video coding of a standardized 10-minute free parent-child interaction.
Secondary outcomes include salivary oxytocin concentration and cortical responses to social and non-social stimuli measured using fNIRS. Morning fasting resting saliva samples will be collected to determine salivary oxytocin concentrations using enzyme-linked immunosorbent assay (ELISA). During fNIRS assessment, children will view social stimuli consisting of a person singing children's songs and non-social stimuli consisting of rolling balls. Oxygenated hemoglobin responses will be examined in regions of interest involved in social cognition, including the fusiform gyrus, superior temporal sulcus, and dorsolateral prefrontal cortex.
The study aims to determine whether maternal interactive massage can improve parent-child interaction quality, increase salivary oxytocin levels, and enhance neural responses to social stimuli in toddlers with ASD. The findings may provide evidence for the development of a standardized, family-based interactive massage intervention for very young children with ASD.
- Conditions
- Autism
- Being tested
- Maternal Interactive Massage, Behavioral
- Keywords
- Autism Spectrum Disorder, Interactive Massage, Early Intervention, Parent-Child Interaction, Oxytocin, fNIRS
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maternal Interactive MassageBehavioural
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
BehavioralBehavioural
Also called Usual Care and ASD Parenting Guidance
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Behavioral |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after the 3-month intervention, and 1 month after completion of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2026
- Study start1 Sep 2025
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiu Xu, Prof., Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07876245
- Sponsor's protocol ID
- IMI-ASD
- Acronym
- IMI-ASD
- Status last verified
- Oct 2026
- First submitted
- 9 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Interactive Massage Intervention in Toddlers With Autism Spectrum Disorder: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07876245
- Acronym / sponsor ID
- IMI-ASD / IMI-ASD
- Conditions
- Autism
- Keywords
- Autism Spectrum Disorder, Interactive Massage, Early Intervention, Parent-Child Interaction, Oxytocin, fNIRS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Autism spectrum disorder (ASD) is a neurodevelopmental disorder characterized by impairments in social communication and the presence of restricted and repetitive behaviors and interests. Early childhood represents an important period for intervention because of rapid neurodevelopment and neural plasticity. However, many existing interventions for ASD can be difficult to implement consistently in family settings because they require substantial professional resources, time, and financial costs. Interactive massage is a convenient, low-cost, family-based non-pharmacological intervention that may support early development by providing tactile and sensory stimulation while promoting parent-child interaction.
Oxytocin plays an important role in social cognition, emotion recognition, and interpersonal bonding and has been associated with social communication abilities in children with ASD. Altered neural responses and functional connectivity in brain regions involved in social cognition have also been reported in ASD. Functional near-infrared spectroscopy (fNIRS) provides a non-invasive and motion-tolerant method for assessing cortical responses in young children. In addition, the quality of early parent-child interaction is an important environmental factor associated with the development of children's social abilities. However, the effects of interactive massage on behavioral, neuroendocrine, and neural outcomes in toddlers with ASD remain insufficiently understood.
This study is a randomized controlled trial designed to evaluate the efficacy of a standardized maternal interactive massage intervention in toddlers aged 18-24 months with ASD. A total of 120 eligible participants will be randomly assigned in a 1:1 ratio to an intervention group or a usual care group.
Mothers of children assigned to the intervention group will receive standardized training in interactive massage techniques, including massage areas, intensity, duration, frequency, and safety procedures. The massage will focus on the head and face, trunk, limbs, and palms and soles and will primarily involve gentle stroking, kneading, and pressing. Mothers will perform the massage for 15 minutes per session, three sessions per day, six days per week, for three consecutive months. The intervention group will also receive usual clinical care and ASD family parenting guidance. Intervention adherence will be monitored through daily records, weekly online follow-up, and monthly in-person follow-up.
Participants assigned to the usual care group will receive routine clinical follow-up and standardized ASD parenting guidance for three months without massage or related massage training during the study period. Mothers in this group will be offered interactive massage training after study completion.
Assessments will be conducted at baseline, immediately after completion of the 3-month intervention, and at a 1-month post-intervention follow-up. The primary outcome is parent-child interaction quality, assessed using the Early Parent-Child Interaction Questionnaire (EPIQ) together with video coding of a standardized 10-minute free parent-child interaction.
Secondary outcomes include salivary oxytocin concentration and cortical responses to social and non-social stimuli measured using fNIRS. Morning fasting resting saliva samples will be collected to determine salivary oxytocin concentrations using enzyme-linked immunosorbent assay (ELISA). During fNIRS assessment, children will view social stimuli consisting of a person singing children's songs and non-social stimuli consisting of rolling balls. Oxygenated hemoglobin responses will be examined in regions of interest involved in social cognition, including the fusiform gyrus, superior temporal sulcus, and dorsolateral prefrontal cortex.
The study aims to determine whether maternal interactive massage can improve parent-child interaction quality, increase salivary oxytocin levels, and enhance neural responses to social stimuli in toddlers with ASD. The findings may provide evidence for the development of a standardized, family-based interactive massage intervention for very young children with ASD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interactive Massage + Usual Care | Experimental | Behavioral: Maternal Interactive Massage, Behavioral: BehavioralParticipants 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. |
| Usual Care | Active comparator | Behavioral: BehavioralParticipants 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. |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maternal Interactive MassageMothers 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 | Behavioural | Interactive Massage + Usual Care |
| BehavioralAlso: Usual Care and ASD Parenting GuidanceParticipants 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. | Behavioural | Interactive Massage + Usual Care, Usual Care |
Primary outcome
Parent-child interaction quality
Time frame: Baseline, immediately after the 3-month intervention, and 1 month after completion of the intervention
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiu Xu, Prof. principal investigator
Children's Hospital of Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maternal Interactive Massage and Behavioral in people with Autism, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingrui Zhou, Dr. (+86 13701989113, zbr1800@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parent-child interaction quality (time frame: Baseline, immediately after the 3-month intervention, and 1 month after completion of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.