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

NCT06596226 | Recruiting

• 1 other identifier: UTD IRB 24-804
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism

Keywords

Autism Intervention; Social development; Social communication

Outcome Measures

Primary Outcomes (3)

• Improved Social skills

  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

  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

  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

Study Arms (2)

Pathways with a Mutal Gaze Protocol

EXPERIMENTAL

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 without Mutual Gaze Protocol

ACTIVE COMPARATOR

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

Interventions

Pathways Parent Mediated Intervention BEHAVIORAL

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.

Pathways with a Mutal Gaze Protocol

Pathways Parent Mediated Intervention without Mutual Gaze BEHAVIORAL

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.

Pathways without Mutual Gaze Protocol

Eligibility Criteria

• Age: 16 Months - 30 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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 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
• Parents must live within a 30-mile radius of the Callier Center Dallas.

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.

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• Texas Higher Education Coordinating Board: collaborator

Study Sites (1)

University of Texas at Dallas

Richardson, Texas, 75080, United States

RECRUITING

Related Publications (7)

• Anagnostou E, Jones N, Huerta M, Halladay AK, Wang P, Scahill L, Horrigan JP, Kasari C, Lord C, Choi D, Sullivan K, Dawson G. Measuring social communication behaviors as a treatment endpoint in individuals with autism spectrum disorder. Autism. 2015 Jul;19(5):622-36. doi: 10.1177/1362361314542955. Epub 2014 Aug 5.

  PMID: 25096930 BACKGROUND

• (Anagnostou et al., 2015; Chatham et al., 2018; McCracken et al., 2021).

  BACKGROUND

• Chatham CH, Taylor KI, Charman T, Liogier D'ardhuy X, Eule E, Fedele A, Hardan AY, Loth E, Murtagh L, Del Valle Rubido M, San Jose Caceres A, Sevigny J, Sikich L, Snyder L, Tillmann JE, Ventola PE, Walton-Bowen KL, Wang PP, Willgoss T, Bolognani F. Adaptive behavior in autism: Minimal clinically important differences on the Vineland-II. Autism Res. 2018 Feb;11(2):270-283. doi: 10.1002/aur.1874. Epub 2017 Sep 21.

  PMID: 28941213 BACKGROUND

• McCracken JT, Anagnostou E, Arango C, Dawson G, Farchione T, Mantua V, McPartland J, Murphy D, Pandina G, Veenstra-VanderWeele J; ISCTM/ECNP ASD Working Group. Drug development for Autism Spectrum Disorder (ASD): Progress, challenges, and future directions. Eur Neuropsychopharmacol. 2021 Jul;48:3-31. doi: 10.1016/j.euroneuro.2021.05.010. Epub 2021 Jun 19.

  PMID: 34158222 BACKGROUND

• Mullen, E. M. (1995). Mullen Scales of Early Learning. American Guidance Service, Guilford Press.

  BACKGROUND

• Wetherby, A., & Prizant, B. (2002). Communication and Symbolic Behavior Scales- Developmental Profile (1st normed ed.). Paul H. Brookes.

  BACKGROUND

• Sparrow, S. S., Cicchetti, D. V., & Saulnier, C. A. (2016). Vineland Adaptive Behavior Scales, Third Edition (Vineland-3). Pearson.

  BACKGROUND

MeSH Terms

Conditions

Autistic Disorder; Communication

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Study Officials

• Pamela Rollins, EdD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Rollins, EdD

CONTACT

9728833153; rollins@utdallas.edu

Chrislove Ulysse

CONTACT

9728833153; Chrislove.Ulysse@utdallas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 21, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)