An interventional study of Maternal Interactive Massage and Behavioral in Autism, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Months to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Treatment
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.
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.
1,360 studies on the registry are indexed under Autistic Disorder; 332 are open to participants now.
This study's planned enrollment of 120 is above the median of 46 across 1,058 interventional studies indexed under Autistic Disorder.
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Exclusion Criteria:
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
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
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
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
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.
Time frame: Baseline, immediately after the 3-month intervention, and 1 month after completion of the intervention
Plan to share: Undecided
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