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NCT06596226
Evaluating Pathways Mutual Gaze Protocol on Social Skills in Young Children Suspected of Autism
Conditions: Autism
Sex: All
Ages: 16 Months – 30 Months
Healthy volunteers: No
Phase: NA
Enrollment: 80
Sponsor: The University of Texas at Dallas
Location: University of Texas at Dallas Richardson Texas
Summary
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT06596226). StuddyBuddy aggregates publicly available trial information.
