NCT06596226

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

Evaluating The Efficacy of Pathways Parent-Mediated Intervention's Mutual Gaze Protocol on Social Skills in Young Children Suspected of Having Autism: A Randomized Control Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: The University of Texas at Dallas · Academic / Other
• Sex: All
• Age: 16 Months – 30 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 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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2024-09-10
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2024-09-19
• Last updated: 2025-10-21

Locations

1 site across 1 country: United States