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

Last updated: October 1, 2024
Sponsor: The University of Texas at Dallas
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Autism Spectrum Disorder (Asd)

Treatment

Pathways Parent Mediated Intervention

Pathways Parent Mediated Intervention without Mutual Gaze

Clinical Study ID

NCT06596226
UTD IRB 24-804
  • Ages 16-30
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 EarliPointTMassessment 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

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 geneticconcerns or disorders;

  • Children whose parents are not fluent in English.

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Pathways Parent Mediated Intervention
Phase:
Study Start date:
September 10, 2024
Estimated Completion Date:
June 01, 2026

Study 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

Connect with a study center

  • University of Texas at Dallas

    Richardson, Texas 75080
    United States

    Active - Recruiting

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