Recruiting

CLR-Pathways vs. CLR-Pathways

Sponsor:

The University of Texas at Dallas

Code:

NCT06733584

Conditions

Autism

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Not accepted

Interventions

Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze

Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention

Study Details

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 a Culturally and Linguistically Responsive adaptation of Pathways Early Intervention (CLR-Pathways) is the key to improving social communication, language, and everyday skills in young (18-42 months) Hispanic autistic children experiencing low income.

What Will Happen: Researchers will compare two versions of CLR-Pathways.

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

What to Expect: Participants will:

  • Attend 16 sessions (or 18 weeks if there are cancellations) of Pathways Intervention, each lasting 1.5 hours.
  • 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

Study ID

NCT06733584

Start date

Sep 22, 2025

Status verified date

Jun, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 1 - 3

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Children must be from a Hispanic family experiencing low income, defined as having an income-to-needs ratio of < 320% of the federal poverty level, determined by their household size
  • Children must be between 18-42 months old at the start of the study
  • Children must have no other known neurological or genetic concerns or disorders determined by parent report
  • Children must receive a Calibrated Severity Score (CSS) of 4 or higher on the Autism Diagnostic Observational Schedule-2 (ADOS-2) administered by a qualified bilingual assessment associate
  • Families must have a primary home language of English and/or Spanish

Exclusion Criteria:

  • Children who are from a family that is not Hispanic and/or does not have an income-to-needs ratio of < 320% of the federal poverty level, determined by their household size
  • Children younger than 18 months or older than 42 months at the start of the study
  • Children whose parents report they have any other known neurological or genetic concerns or disorders
  • Children who receive a Calibrated Severity Score (CSS) lower than 4 on the ADOS-2
  • Families who do not have English or Spanish as a primary home language

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Culturally and Linguistically Responsive Pathways with a Mutual Gaze Protocol

16 90-minute sessions (or 18 weeks, whichever comes first) of a Culturally and Linguistically Responsive adaptation of the Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI; research version). Pathways is parent-mediated and uses a coaching model.

active comparator: Culturally and Linguistically Responsive Pathways without Mutual Gaze Protocol

16 90-minute sessions (or 18 weeks, whichever comes first) of a Culturally and Linguistically Responsive adaptation of the Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI; research version) without the Mutual Gaze Protocol. Pathways is parent-mediated and uses a coaching model.

Interventions

Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze

Pathways-trained bilingual 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 and audio version of the program manual which has been adapted to be culturally and linguistically responsive to the Hispanic community. Sessions will review information about social communication, social sensory routines, and using naturalistic developmental behavioral strategies. Interventionists will demonstrate intervention strategies and provide caregivers with feedback and self-reflection.

Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention

Pathways-trained bilingual 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 and audio version of the program manual which has been adapted to be culturally and linguistically responsive to the Hispanic community. 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 feedback and self-reflection.

Primary outcome measure

  • Change in Respeto [ 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 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 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 ]
  • Change in Social Attention [ 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 Intentional Communication [ 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 Expressive Language [ 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 ]

Central Contacts and Locations

Central contacts

Pamela Rollins, EdD

972-883-3153rollins@utdallas.edu

Erin E Kosloski, BA

erin.kosloski@utdallas.edu

Locations

Catholic Charities of Dallas

Recruiting

Dallas, Texas, United States, 75247

Contacts

Ana Schaller, PhD

214-337-0175aschaller@ccdallas.org

University of Texas at Dallas

Recruiting

Richardson, Texas, United States, 75080

Contacts

Pamela Rollins, EdD

972-883-3153rollins@utdallas.edu

Erin E Kosloski, BA

erin.kosloski@utdallas.edu

More Information

Sponsor

The University of Texas at Dallas

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • Autism Intervention
  • Cultural and Linguistic Responsivity
  • Social development
  • Social communication
  • Hispanic

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by The University of Texas at Dallas on 2026-06-05.