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.

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.

Inclusion Criteria:

• Children must be from a Hispanic family experiencing low income, defined as having an income-to-needs ratio of < 320% of the federal poverty level, determined by their household size
• Children must be between 18-42 months old at the start of the study
• Children must have no other known neurological or genetic concerns or disorders determined by parent report
• Children must receive a Calibrated Severity Score (CSS) of 4 or higher on the Autism Diagnostic Observational Schedule-2 (ADOS-2) administered by a qualified bilingual assessment associate
• Families must have a primary home language of English and/or Spanish

Exclusion Criteria:

• Children who are from a family that is not Hispanic and/or does not have an income-to-needs ratio of < 320% of the federal poverty level, determined by their household size
• Children younger than 18 months or older than 42 months at the start of the study
• Children whose parents report they have any other known neurological or genetic concerns or disorders
• Children who receive a Calibrated Severity Score (CSS) lower than 4 on the ADOS-2
• Families who do not have English or Spanish as a primary home language

The shared data will include de-identified demographic data and item-level data from measures administered to participants, as well as analyzed data.

The data sharing schedule for demographic and study measure data is expected to begin approximately one year after the start of the project, with updates every 6 months. Analyzed data will be shared after the project is complete. It is our expectation that the data will persist in NDA's database for that organization's lifespan.

The Database Engineer in the Research Design and Analysis (RDA) of the Life Span Institute at the KU will report the collected data to the National Institute of Mental Health Data Archive (NDA). NDA provides a robust system for defining data dictionaries and metadata for all datasets, and the uploaded data itself will be in delimited plain text format. Implementation of this data sharing plan will be the responsibility of RDA.