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

NCT ID: NCT06596226

Last Updated: 2025-10-21

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2026-06-01

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.

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

Conditions

Autism

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Pathways Parent Mediated Intervention

Intervention Type: 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 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.

Group Type: ACTIVE_COMPARATOR

Pathways Parent Mediated Intervention without Mutual Gaze

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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 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.

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.

• Minimum Eligible Age: 16 Months
• Maximum Eligible Age: 30 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Higher Education Coordinating Board

OTHER_GOV

Sponsor Role: collaborator

The University of Texas at Dallas

OTHER

Sponsor Role: lead

Responsible Party

Pamela Rollins

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pamela Rollins, EdD

Role: PRINCIPAL_INVESTIGATOR

University of Texas at Dallas

Locations

University of Texas at Dallas

Richardson, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pamela Rollins, EdD

Role: CONTACT

rollins@utdallas.edu

9728833153

Chrislove Ulysse

Role: CONTACT

Chrislove.Ulysse@utdallas.edu

9728833153

Facility Contacts

Pamela Rollins, Ed.D

Role: primary

rollins@utdallas.edu

9728833153

Chrislove Ulysse, BS

Role: backup

Chrislove.Ulysse@UTDallas.edu

9728833153

References

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.

Reference Type: BACKGROUND

PMID: 25096930 (View on PubMed)

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

Reference Type: 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.

Reference Type: BACKGROUND

PMID: 28941213 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 34158222 (View on PubMed)

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

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

Reference Type: BACKGROUND

Other Identifiers

UTD IRB 24-804

Identifier Type: -

Identifier Source: org_study_id