Evaluating the Efficacy of Pathways Parent-Mediated Early Autism Intervention on Social Attention and Language

March 18, 2025 updated by: Pamela Rollins, The University of Texas at Dallas

Evaluating the Efficacy of Pathways Early Autism Intervention on Social Orienting, Joint Attention and Social Language: a Randomized Control Trial

The goal of this clinical trial is to compare the efficacy of Pathways parent-mediated early autism intervention (Pathways) and a parent education intervention (PEI) delivered to culturally and linguistically diverse families with children 12-42 months of age suspected of or diagnosed with autism.

Question 1: Is Pathways more effective than a PEI at (a) fostering the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism and (b) relieving their parents' stress?

Question 2: Is the magnitude of the relationship between early and later developing attention greater in children whose parents receive Pathways compared to children whose parents receive PEI?

Question 3: Is the magnitude of the relationship between joint attention and social communication and language greater in children whose parents receive Pathways compared to children whose parents receive PEI?

Participants will be randomized into 24 weeks of Pathways or PEI. Participants will receive a battery of assessments to evaluate the child's cognitive, social attention, social communication, language, and adaptive functioning, and parental stress at four different time points spaced every 12 weeks from baseline to three-month follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study aims to evaluate the efficacy of all ten units of Pathways parent-coaching early autism intervention. A limitation of our previous 12-week intervention research was that in 12 weeks, we could only assess efficacy for the first five Pathways units. The first five units focus on dyadic social skills (i.e., social orienting, mutual gaze, getting the social partner's attention, and mutual imitation). The last five Pathways units (units 6-10) build on these foundational skills and focus on facilitating triadic social skills (i.e., joint attention, social communication, and language). Joint attention is an essential component of social communication and provides the context for social communication and language. Therefore, it is vital to establish the efficacy of the entire Pathways program (i.e., all ten units) on the development of social orienting, joint attention, social communication, and language.

Aim 1: To identify the effectiveness of the entire Pathways program on (a) the development of social orienting, joint attention, and social communication and language in children with a research diagnosis of autism; and (b) relieving their parents' stress.

Aim 2: To identify the relationship between early social orienting and later joint attention, social communication, and language skills.

We hypothesize that Pathways will moderate the effect of (1) growth in social orienting after receiving 12 weeks of intervention and (2) growth in joint attention and social communication and language after receiving 24 weeks of intervention. Further, we hypothesize social orienting after 12 weeks of intervention is significantly related to joint attention at 24 weeks. Finally, we expect that joint attention at 24 weeks will be significantly related to language at 36 weeks (i.e., at a 3-month follow-up). In terms of parenting stress, we expect to find a significant effect of Pathways on decreasing parent stress during the first 12 weeks of intervention, followed by a plateau.

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Dallas, Texas, United States, 75235
        • The University of Texas/Callier Center for Communication Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 3 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Caregivers and their children who

  • are between 12-42 months old at the start of the study;
  • diagnosed with or suspected of having autism
  • have no other known neurological or genetic concerns or disorders;
  • have a primary home language of English or Spanish;
  • has an ASD diagnosis corroborated by the Autism Diagnostic Observation Schedule (ADOS-2) administered by study researchers;
  • live in Dallas Texas within a 30-mile radius of the downtown location of the UTD/Callier Center for Communication Disorders.

Exclusion Criteria:

  • anyone not meeting the inclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pathways Intervention
Twenty-four weeks of a manualized Naturalistic Developmental Behavioral Intervention (NDBI) parent-mediated early autism intervention that uses a coaching model.
Behavioral: Pathways Intervention
Pathways-trained research clinicians will conduct 90-minute weekly coaching sessions with caregivers (in English or Spanish) in the family's home or other convenient location. Caregivers will receive a written and audio version of the program manual in English or Spanish, depending on the family's home language. Sessions will review information about autism, interactional strategies, and Applied Behavioral Analysis (ABA) techniques from the program manual, demonstrate intervention strategies, and provide caregivers with practice feedback and self-reflection.
Active Comparator: Parent Education Intervention (PEI)
Twenty-four weeks of individual caregiver training without the child being present.
Behavioral: Parent Education Intervention (PEI)
Caregivers will access a 20-30-minute video lesson and associated handouts (in English or Spanish, depending on the parent's home language) every other week for 24 weeks. On the off week, the caregiver will meet with a trained clinician (in English or Spanish) for 30 minutes without the child. Lessons will cover autism, social attention delays, evidence-based interventions, self-regulation, talking with your child, playing with your child, principles of managing behavior, knowing your rights, and self-care. The first and last visit will occur in the family's home or another convenient location. All other visits will take place over Zoom videoconferencing software.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in child social orienting
Time Frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Assessors blind to group and time will code video recordings from two structured clinician-child interactions (CCI). Both CCIs will be recorded using an iPad or small video camera for a wide-angle view of the interaction and hidden camera eyeglasses worn by the clinician to capture the location and direction of the child's eye gaze. Change in the rate of social orienting (number of occurrences/total time engaged with the clinicians across the two structured interactions) will be measured.
Assessed for changes every 12 weeks from baseline to 36 weeks
Changes in child Joint attention
Time Frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Assessors blind to group and time will code video recordings from two structured clinician-child interactions (CCI). Both CCIs will be recorded using an iPad or small video camera for a wide-angle view of the interaction and hidden camera eyeglasses worn by the clinician to capture the location and direction of the child's eye gaze. Change in the rate of joint attention (number of occurrences/total time engaged with the clinicians across the two structured interactions) will be measured.
Assessed for changes every 12 weeks from baseline to 36 weeks
Change in child social communication
Time Frame: Assessed for changes every 12 weeks from baseline to 36 weeks
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. The CSBS-DP is a direct assessment of early social communication.
Assessed for changes every 12 weeks from baseline to 36 weeks
Change in child language
Time Frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Change in the raw scores obtained on The Preschool Language Scales 5th Edition (PLS-5) will be measured. The PLS-5 is a standardized measure of language.
Assessed for changes every 12 weeks from baseline to 36 weeks
change in intentional communication
Time Frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Assessors blind to group and time will code video recordings from six minutes of a structured clinician-child interactions using the Early Communication Indicator (ECI). The ECI is a weighted measure of intentional communication.
Assessed for changes every 12 weeks from baseline to 36 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in parenting stress
Time Frame: Assessed for changes every 12 weeks from baseline to 36 weeks
Change in percentile scores obtained on Parenting Stress Index-4 (PSI-4) will be measured. PSI-4 is a standardized parent questionnaire on which parents rate agreement on 36 items using a five-point Likert scale.
Assessed for changes every 12 weeks from baseline to 36 weeks
changes in child adaptive functioning
Time Frame: Assessed for changes from baseline to 24 weeks and from 24-to-36 weeks
Change in raw scores obtained on Vineland Adaptive Behavior Scales, Second Edition (Vineland II) will be measured. The Vineland II is a standardized parent interview to assess adaptive functioning.
Assessed for changes from baseline to 24 weeks and from 24-to-36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas at Dallas

Investigators

  • Principal Investigator: Pamela R Rollins, Ed.D, University of Texas at Dallas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2022

Primary Completion (Actual)

February 1, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

October 27, 2022

First Submitted That Met QC Criteria

November 2, 2022

First Posted (Actual)

November 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UTD IRB 22 - 665

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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