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

Running, not enrolling · Not applicable

Conditions studied: Autism

In brief

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.

Key facts

Study ID: NCT06596226
Run by: The University of Texas at Dallas
People needed: 80
Starts: 2024-09-10
Expected to finish: 2026-12-15
Last updated by the study team: 2026-06-26

Who can join

Age: 1 and older, up to 3. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

You may not qualify if…

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

Where it is running

University of Texas at Dallas — Richardson, Texas, United States

Full record on ClinicalTrials.gov

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