Meeting the Needs of Young Hispanic Autistic Children

NCT06733584 | Recruiting

• 2 other identifiers: UTD IRB-24-306HT94252410184 / AR230003
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

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 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.

Conditions

Autism

Keywords

Autism Intervention; Cultural and Linguistic Responsivity; Social development; Social communication; Hispanic

Outcome Measures

Primary Outcomes (6)

• Change in Respeto

  Two dyadic measures of respeto will be coded using two items from the Joint Engagement Rating Inventory (JERI; Adamson et al., 2020). The Parent Calm Authority (PCA) subscale will measure the extent to which a parent influences the interaction using an assertive and confident yet gentle approach. The Child Affiliative Obedience (CAO) subscale will capture the child's affiliation, deference, and amenability to the parent's direction. These are scored using 7-point Likert scales (where 1 indicates no PCA or CAO, respectively). These measures will be derived from 12-minute naturalistic parent-child interaction video recordings. The interactions will be video-recorded from a wide-angle view as well as from hidden camera eyeglasses worn by the adult to capture the location and direction of the child's the location and direction of the child's eye gaze. The two streams of digitized videos will be time-linked and subsequently coded for measures of respeto.

  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 Social Communication Skills

  Change in the raw scores obtained on the Social, Speech and Symbolic composites of The Communication and Symbolic Behavior Scales- Developmental Profile (CSBS-DP; Wetherby \& Prizant, 2002) will be measured. Raw scores for the Social, Speech and Symbolic composites 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 designed for children with a functional communication age between 6 months and 2 years.

  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 Adaptive Functioning

  Change in the raw scores obtained on the Communication, Daily Living, Socialization, and Motor Development domains of the Vineland Adaptive Behavior Scales, Second Edition (VABS-II; Sparrow et al., 2005) will be measured. Raw scores for these domains range from 0-252, 0-286, 0-224, 0-154 respectively (lower scores being worse outcomes). The VABS-II is a standardized parent report measure of adaptive functioning designed for individuals from birth to age 90.

  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 Social Attention

  The amount of time the child initiates eye gaze to the adult's eyes paired with positive affect will be measured (see Rollins et al., 2021 for a detailed description of this measure). This measure will be derived from 12-minute adult-child interaction video recordings wherein the child interacts with an unfamiliar adult during a semi-naturalistic play session. These interactions will be video-recorded from a wide-angle view as well as from hidden camera eyeglasses worn by the adult to capture the location and direction of the child's eye gaze. The two streams of digitized videos will be time-linked and subsequently coded for social orienting.

  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 Intentional Communication

  Intentional communication will be measured using the Early Communication Indicator (EC Indicator; Greenwood et al., 2006). The EC Indicator yields a total weighted communication score weighting gestures and vocalizations as 1, single words as 2 and multiple words as 3. Each utterance will also be coded for the child's attentional focus when communicating (attention to object, attention to adult, coordinated attention to object and adult). This measure will be derived from 12-minute adult-child interaction video recordings wherein the child interacts with an unfamiliar adult during a semi-naturalistic play session. These interactions will be video-recorded from a wide-angle view as well as from hidden camera eyeglasses worn by the adult to capture the location and direction of the child's eye gaze. The two streams of digitized videos will be time-linked, orthographically transcribed at the level of the utterance, and subsequently coded for intentional communication.

  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 Expressive Language

  Expressive language will be measured via the Moving Average Number of Different Words (MANDW) and Mean Length of Utterance in words (MLUw) calculated using the Systematic Analysis of Language Transcripts (SALT; Miller \& Iglesias, 2020) software. MANDW measures expressive vocabulary using a moving window to estimate the number of different words, controlling for variability in length across language samples. MLUw measures combinatorial language by calculating the ratio of main body words to the number of utterances produced. This measure will be derived from 12-minute adult-child interaction video recordings wherein the child interacts with an unfamiliar adult during a semi-naturalistic play session. These interactions will be video-recorded from a wide-angle view as well as from hidden camera eyeglasses worn by the adult to capture the location and direction of the child's eye gaze. The two streams of digitized videos will be time-linked and orthographically transcribed.

  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

Secondary Outcomes (3)

• Change in Triadic Joint Attention

  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 Social Connectedness

  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 Proportion of Grammaticality

  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

Study Arms (2)

Culturally and Linguistically Responsive Pathways with a Mutual Gaze Protocol

EXPERIMENTAL

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.

Behavioral: Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention

Culturally and Linguistically Responsive Pathways without Mutual Gaze Protocol

ACTIVE COMPARATOR

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.

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

Interventions

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

Pathways-trained bilingual research clinicians will conduct 90-minute weekly coaching sessions with caregivers in the family's home or other convenient location. Caregivers will receive a written and audio version of the program manual which has been adapted to be culturally and linguistically responsive to the Hispanic community. Sessions will review information about social communication, social sensory routines, and using naturalistic developmental behavioral strategies. Interventionists will demonstrate intervention strategies and provide caregivers with feedback and self-reflection.

Culturally and Linguistically Responsive Pathways without Mutual Gaze Protocol

Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention BEHAVIORAL

Pathways-trained bilingual research clinicians will conduct 90-minute weekly coaching sessions with caregivers in the family's home or other convenient location. Caregivers will receive a written and audio version of the program manual which has been adapted to be culturally and linguistically responsive to the Hispanic community. Sessions will review information about social communication, infusing mutual gaze in social sensory routines, and using naturalistic developmental behavioral strategies. Interventionists will demonstrate intervention strategies and provide caregivers with feedback and self-reflection.

Culturally and Linguistically Responsive Pathways with a Mutual Gaze Protocol

Eligibility Criteria

• Age: 18 Months - 42 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas at Dallas: lead
• Congressionally Directed Medical Research Programs: collaborator
• Catholic Charities: collaborator
• University of Kansas: collaborator

Study Sites (3)

University of Kansas

Lawrence, Kansas, 66045, United States

ACTIVE NOT RECRUITING

Catholic Charities of Dallas

Dallas, Texas, 75247, United States

RECRUITING

University of Texas at Dallas

Richardson, Texas, 75080, United States

RECRUITING

Related Publications (8)

• Rollins PR, Campbell M, Hoffman RT, Self K. A community-based early intervention program for toddlers with autism spectrum disorders. Autism. 2016 Feb;20(2):219-32. doi: 10.1177/1362361315577217. Epub 2015 Apr 23.

  PMID: 25907978 BACKGROUND

• Greenwood CR, Walker D, Buzhardt J, J Howard W, McCune L, Anderson R. Evidence of a Continuum in Foundational Expressive Communication Skills. Early Child Res Q. 2013 Jul 1;28(3):540-554. doi: 10.1016/j.ecresq.2013.02.006.

  PMID: 24882940 BACKGROUND

• Hamilton CM, Strader LC, Pratt JG, Maiese D, Hendershot T, Kwok RK, Hammond JA, Huggins W, Jackman D, Pan H, Nettles DS, Beaty TH, Farrer LA, Kraft P, Marazita ML, Ordovas JM, Pato CN, Spitz MR, Wagener D, Williams M, Junkins HA, Harlan WR, Ramos EM, Haines J. The PhenX Toolkit: get the most from your measures. Am J Epidemiol. 2011 Aug 1;174(3):253-60. doi: 10.1093/aje/kwr193. Epub 2011 Jul 11.

  PMID: 21749974 BACKGROUND

• Zimmerman, I. L., Steiner, V. G., & Pond, R. E. (2011). Preschool language scales (5th ed.). Pearson.

  BACKGROUND

• Sparrow S. S., Cicchetti D. V., Balla D. A. (2005). Vineland Adaptive Behavior Scales, Second Edition (Vineland-II). San Antonio, TX: Pearson.

  BACKGROUND

• Kosloski EE, Patel SD, Rollins PR. The Role of Pathways Early Autism Intervention in Improving Social Skills and Respeto for Young Hispanic Autistic Children. J Autism Dev Disord. 2025 Sep;55(9):3167-3178. doi: 10.1007/s10803-024-06419-x. Epub 2024 Jun 6.

  PMID: 38842669 BACKGROUND

• Rollins PR, De Froy AM, Gajardo SA, Brantley S. Pragmatic contributions to early vocabulary and social communication in young autistic children with language and cognitive delays. J Commun Disord. 2022 Sep-Oct;99:106243. doi: 10.1016/j.jcomdis.2022.106243. Epub 2022 Jun 22.

  PMID: 35797775 BACKGROUND

• Rollins PR, De Froy A, Campbell M, Hoffman RT. Mutual Gaze: An Active Ingredient for Social Development in Toddlers with ASD: A Randomized Control Trial. J Autism Dev Disord. 2021 Jun;51(6):1921-1938. doi: 10.1007/s10803-020-04672-4.

  PMID: 32894382 BACKGROUND

Related Links

• This is the manual for the Joint Engagement Rating Inventory. \[Adamson, L.B., Bakeman, R., \& Suma, K. (2020). The joint engagement rating inventory. Department of Psychology, Georgia State University.\]
• This is the link to the Autism Diagnostic Observation Schedule, Second Edition. \[Lord, C., Luyster, R., Gotham, K., \& Guthrie, W. (2012). Autism Diagnostic Observation Schedule (ADOS-2) (2nd ed.). Western Psychological Services.\]
• This is the link to the Bayley Scales of Infant and Toddler Development, Fourth Edition. \[Bayley, N., \& Aylward, G. P. (2019). Bayley Scales of Infant and Toddler Development (4th ed.). Pearson.\]
• This is a link to the Communication and Symbolic Behavior Scales. \[Wetherby, A., \& Prizant, B. (2002). Communication and Symbolic Behavior Scales- Developmental Profile (1st normed ed.). Paul H. Brookes.\]

MeSH Terms

Conditions

Autistic Disorder; Communication

Interventions

Culture Techniques

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Behavior

Intervention Hierarchy (Ancestors)

In Vitro Techniques; Investigative Techniques

Study Officials

• Pamela Rollins, EdD

  The University of Texas at Dallas

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Rollins, EdD

CONTACT

972-883-3153; rollins@utdallas.edu

Erin E Kosloski, BA

CONTACT

erin.kosloski@utdallas.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: September 22, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 5, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: 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.
• Access Criteria: 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.

Locations

US (3)