The Mother-infant Touch Study (MITS)

November 6, 2026 updated by: Yale University

The purpose of this research study is to learn more about mother-infant interactions, including how infants experience different types of touch.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Mothers aged 21-45 years of infants aged 4-6 months
  • English-speaking
  • Able to provide informed consent

Exclusion Criteria:

  • Mothers of infants who have severe health or developmental disorders;
  • Mothers evidencing the presence of severe psychiatric symptoms (e.g., disorganized speech, reporting delusions)
  • Persons incapable of giving informed consent
  • Mothers reporting recent substance use as determined by the ASI Lite
  • Mothers of infants who present with neurological impairments (e.g., epilepsy/seizures)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Task

All infant participants will receive CT-optimal touch, non-CT optimal touch, and no stroking touch condition
Other: Physical touch

All infant participants will receive CT-optimal touch, non-CT optimal touch, and no stroking touch condition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Infant heart-evoked potentials
Time Frame: During experimental task on the study visit day (1 day)

The amplitude of infant heart-evoked potentials will be examined as a function of the experimental touch condition (CT optimal touch, non-CT optimal touch, and non stroking touch).
During experimental task on the study visit day (1 day)
Infant heart rate
Time Frame: During experimental task on the study visit day (1 day)

Infant heart rate will be examined as a function of the experimental touch condition (CT optimal touch, non-CT optimal touch, and non stroking touch).
During experimental task on the study visit day (1 day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Texas A&M University

Investigators

  • Principal Investigator: Helena Rutherford, PhD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2026

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Study Registration Dates

First Submitted

November 6, 2026

First Submitted That Met QC Criteria

November 6, 2026

First Posted (Actual)

November 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 13, 2026

Last Update Submitted That Met QC Criteria

November 6, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2000040366
  • R21HD122045 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD to be shared (all de-identified):

Infant EEG and ECG Data Maternal Self-Reported Questionnaire and Interview Data Quantitative scores from behavioral coding of video recordings of infants and mother-infant interactions Infant tactile sensitivity

IPD Sharing Time Frame

At the time of publication

IPD Sharing Access Criteria

Data will be made available on OpenNeuro and Open Science Framework

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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