Meeting the Needs of Young Hispanic Autistic Children

The University of Texas System (UT)

Status: Enrolling

Conditions: Autism

Treatments: Behavioral: Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention; Behavioral: Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06733584

UTD IRB-24-306

HT94252410184 / AR230003 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 42 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Children must be from a Hispanic family experiencing low income, defined as having an income-to-needs ratio of < 200% 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 < 200% 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups

Culturally and Linguistically Responsive Pathways with a Mutual Gaze Protocol

Experimental group

Description:

16 90-minute sessions (or 18 weeks, whichever comes first) of a Culturally and Linguistically Responsive adaptation of the Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI; research version). Pathways is parent-mediated and uses a coaching model.

Treatment:

Behavioral: Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention

Culturally and Linguistically Responsive Pathways without Mutual Gaze Protocol

Active Comparator group

Description:

16 90-minute sessions (or 18 weeks, whichever comes first) of a Culturally and Linguistically Responsive adaptation of the Pathways manualized Naturalistic Developmental Behavioral Intervention (NDBI; research version) without the Mutual Gaze Protocol. Pathways is parent-mediated and uses a coaching model.

Treatment:

Behavioral: Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze