Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism

May 29, 2026 updated by: Pamela Rollins, The University of Texas at Dallas

Evaluating The Efficacy of Pathways Parent-Mediated Intervention's Mutual Gaze Protocol on Social Skills in Young Children Suspected of Having Autism: A Randomized Control Trial

Purpose of the Study: The goal of this clinical trial is to find out if a technique called the "mutual gaze procedure," used in Pathways Early Intervention (Pathways), is the key to helping improve social communication, language, and everyday skills in young children (16-30 months old) who are at high risk for autism, particularly those from diverse cultural and language backgrounds.

What Will Happen: Researchers will compare two versions of the Pathways Intervention:

  • Version 1: Includes mutual gaze strategies.
  • Version 2: Does not include mutual gaze strategies.

What to Expect: Participants will:

  • Attend 12 sessions of Pathways Intervention, each lasting 1.5 hours (or 15 weeks if there are cancellations).
  • Come to the clinic for a developmental check-up three times: before starting Pathways, right after completing Pathways, and three months after finishing Pathways.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Purpose of the Study: The primary goal of this clinical trial is to evaluate whether a parent-mediated treatment can improve social communication, language, and adaptive functioning in 16-30-month-old children from diverse cultural and language backgrounds who are at high risk for autism (referred to as children with social challenges).

Study Design:

  • Study Phase: N/A
  • Intervention Model: Participants are assigned to one of two groups in parallel.

Study Description:

  • Participants: 80 children aged 16-30 months who show social communication challenges and are at high risk for autism will be randomly assigned to one of two groups:

    1. Group 1: Pathways Intervention with mutual gaze strategies.
    2. Group 2: Pathways Intervention without mutual gaze strategies.
  • Intervention Sessions: Participants will attend 12 sessions, each lasting 1.5 hours, over approximately 15 weeks (allowing for possible cancellations) of parent-mediated intervention in their homes or another convenient location.

Assessments: To track progress and evaluate long-term effects, participants will undergo several culturally and linguistically appropriate assessments at three time points:

  1. Baseline: Within two weeks before starting the intervention.
  2. Post-Intervention: Within two weeks after completing the intervention.
  3. Three-Month Follow-Up: 12-15 weeks after completing the intervention.

Each evaluation will take around two hours and will include:

  • Child Assessments:

    • Mullen Scale of Early Learning (MSEL): Assesses general developmental age (administered only at baseline).
    • Communication and Symbolic Behavior Scales-Developmental Profile (CSBS-DP): Evaluates social communication.
    • EarliPointTM: Measures social, verbal, and nonverbal cognition.

  • Caregiver Questionnaires:

    • Vineland Adaptive Behavior Scales, Third Edition (VABS-III): Assesses adaptive functioning.
    • PhenX Toolkit Core Measures: Collects family and child demographic information, including parents' and grandparents' place of birth (administered only at baseline).

The CSBS-DP and VABS-III have been validated as appropriate measures for determining meaningful changes in children with or at high risk for autism, based on previous research

Study Type

Interventional

Enrollment (Estimated)

80

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 Locations

  • United States
    • Texas
      • Richardson, Texas, United States, 75080
        • University of Texas at Dallas

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Children must be between 16-30 months old at the start of the study;
  • Children must receive social disability index of 7 or lower if child is 16-20 months old, or 8.1 or lower if child is 21-30 months old on the EarliPointTM assessment with a researcher (i.e., human) confirming social challenges are present;
  • Parents must report no other known neurological or genetic concerns or disorders
  • Parents must be fluent in English or Spanish
  • Parents must live within a 30-mile radius of the Callier Center Dallas or Callier Center Richardson.

Exclusion Criteria:

  • Children younger than 16 months or older than 30 months at the start of the study
  • Children who are not at high risk for autism based on an EarliPointTM assessment (with researcher confirmation of social challenges)
  • Children whose parents report they have any other known neurological or genetic concerns or disorders;
  • Children whose parents are not fluent in English or Spanish

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pathways with a Mutal Gaze Protocol
12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version). Pathways uses a coaching model.
Behavioral: Pathways Parent Mediated Intervention
Pathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers in the family's home or other convenient location. Caregivers will receive a written version of the program manual. Sessions will review information about social communication, infusing mutual gaze in social sensory routines, and using naturalistic developmental behavioral strategies. Interventionists will demonstrate intervention strategies and provide caregivers with practice feedback and self-reflection.
Active Comparator: Pathways without Mutual Gaze Protocol
12 90-minute sessions (or 15 weeks, whichever comes first) of Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated intervention (research version) without the Mutual Gaze protocol. Pathways uses a coaching model.
Behavioral: Pathways Parent Mediated Intervention without Mutual Gaze
Pathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers in the family's home or other convenient location. Caregivers will receive a written version of the program manual. Sessions will review information about social communication, social sensory routines, and naturalistic developmental behavioral strategies described in the program manual. Interventionists will demonstrate intervention strategies and provide caregivers with practice feedback and self-reflection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improved Social skills
Time Frame: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Assessors blind to group assignment will evaluate each child for social skills using the EarliPointTM The EarliPointTM is an FDA-authorized eye-tracking tool that uses artificial intelligence (AI) eye-tracking technology to assess social disability in children between 16 and 30 months by measuring the number of social interactions a child observes on the portable eye-tracking screen. EarliTech will be used to measure improved social skills. There are 2 different EarliTech Scores: social disability and Verbal and nonverbal. Social disability scores range from -15 to +25, higher scores indicate better ability. Verbal and nonverbal scores range from 0-90, high scores indicate better ability.
At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Improved Social Communication Skills
Time Frame: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Change in the raw scores obtained on the social, speech and symbolic composite of The Communication and Symbolic Behavior Scales- Developmental Profile (CSBS-DP) will be measured. Raw scores for the social, speech and symbolic composite range from 0-64, 0-54 and 0-53 respectively, 0 being the worst score. The CSBS-DP is a direct assessment of early social communication.
At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
Change in Adaptive Functioning
Time Frame: At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up
The Vineland II is a standardized parent interview to assess adaptive functioning. Change in raw scores obtained on Vineland Adaptive Behavior Scales, Second Edition (Vineland II) will be measured. The Vineland II has 4 domains - Communication, Daily Living, Social Skills and Relationships, Physical Activity. The raw scores for these domains range from 0-252, 0-286, 0-224, 0-154 respectively (lower scores being worse outcomes).
At baseline (i.e., within two weeks prior to the start of intervention); Post-intervention (i.e., within two weeks after completing the intervention); At three-month follow-up

Collaborators and Investigators

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

Sponsor

The University of Texas at Dallas

Collaborators

Texas Higher Education Coordinating Board

Investigators

  • Principal Investigator: Pamela Rollins, EdD, The University of Texas at Dallas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

September 10, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

August 21, 2024

First Submitted That Met QC Criteria

September 12, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

June 3, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTD IRB 24-804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Considering reporting the collected data to the National Institute of Mental Health Data Archive (NDA). NDA provides a robust system for defining data dictionaries and metadata for all datasets, and the uploaded data itself will be in delimited plain text format. The shared data will include demographic data and measures administered to participants, as well as analyzed data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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