NCT06733584

Meeting the Needs of Young Hispanic Autistic Children

Meeting the Needs of Young Hispanic Autistic Children: Developing a Culturally and Linguistically Sensitive Intervention to Alleviate Core Social Challenges

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: The University of Texas at Dallas · Academic / Other
• Sex: All
• Age: 18 Months – 42 Months
• Healthy volunteers: Not accepted

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.

Detailed description

Study Description: * Participants: 200 Hispanic autistic children experiencing low income and their caregivers will be randomly assigned to one of two groups in parallel: 1. Group 1: CLR-Pathways Intervention with mutual gaze strategies. 2. Group 2: CLR-Pathways Intervention without mutual gaze strategies. * Intervention Sessions: Participants will attend 16 sessions, each lasting 1.5 hours, over approximately 18 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 approximately 2-3 hours and will include: * Child Assessments: * Autism Diagnostic Observation Schedule, Second Edition (ADOS-2; Lord et al., 2012): Researchers will use the ADOS-2 to assess communication, social interaction, play, and restricted/repetitive behaviors and to confirm a research diagnosis of autism (administered only at baseline) * Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4; Bayley \& Aylward, 2019): Researchers will use the Bayley-4 to measure cognitive and motor skills (administered only at baseline) * Preschool Language Scales, Fifth Edition (PLS-5; Zimmerman et al., 2011): Researchers will use the English or Spanish version of the PLS-5 to assess receptive language age (administered only at baseline) * Communication and Symbolic Behavior Scales-Developmental Profile (CSBS-DP; Wetherby \& Prizant, 2002): Researchers will use the CSBS-DP to evaluate social communication. * Caregiver Questionnaires: * PhenX Toolkit Core Measures (PhenX; Hamilton et al., 2011): Researchers will use the PhenX to collect family and child demographic information, including parents' and grandparents' place of birth. * Vineland Adaptive Behavior Scales, Third Edition (VABS-III; Sparrow et al., 2016): Researchers will use the VABS-III to assess adaptive functioning. * Post-intervention Social Validity Questionnaire (Rollins et al., 2016): Researchers will use a questionnaire from a previous intervention efficacy study to assess the social validity of the intervention. 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. • Video-Recorded Measures: * Adult-Child Interactions (ACIs): Twelve-minute recordings will be transcribed and coded for social orienting, the Fluency and Connectedness and Joint Engagement measures of the Joint Engagement Rating Inventory (JERI; Adamson et al., 2020), intentional communication (EC Indicator; Greenwood et al., 2006), and expressive language. * Parent-Child Interactions (PCIs): Twelve-minute naturalistic recordings will be coded for the Parent Calm Authority and Child Affiliative Obedience measures of the JERI.

Conditions

• Autism

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2025-09-22
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2024-12-13
• Last updated: 2025-11-05

Locations

3 sites across 1 country: United States