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

Not Applicable

Recruiting

• Conditions: Autism

• Registration Number: NCT06596226
• Lead Sponsor: The University of Texas at Dallas

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

Study Timeline

• Study First Submitted: 2024-08-21
• Study Start: 2024-09-10
• Study First Submitted QC: 2024-09-12
• Study First Posted: 2024-09-19
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-03
• Primary Completion: 2026-06-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improved Social skills	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	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.
Improved Social Communication Skills	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 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.
Change in Adaptive Functioning	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	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).

Trial Locations

Locations (1)

University of Texas at Dallas; 🇺🇸 Richardson, Texas, United States