AutismNCT06733584
Meeting the Needs of Young Hispanic Autistic Children
A study testing Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze and Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention in people with Autism, run by The University of Texas at Dallas at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 42 months
- Conditions the study is for
- Autism
- What is being tested?
- Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze and Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesUnited States
- Study dates
- 22 Sep 2025to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Erin E Kosloski, BA contact
United States3 sites, 2 recruiting
- Recruiting
Catholic Charities of Dallas
Dallas, Texas, 75247
Ana Schaller, PhD, 214-337-0175, aschaller@ccdallas.org
- Active, not recruiting
University of Kansas
Lawrence, Kansas, 66045
- Recruiting
University of Texas at Dallas
Richardson, Texas, 75080
Pamela Rollins, EdD, 972-883-3153, rollins@utdallas.edu
Erin E Kosloski, BA, erin.kosloski@utdallas.edu
About this study
Official title: Meeting the Needs of Young Hispanic Autistic Children: Developing a Culturally and Linguistically Sensitive Intervention to Alleviate Core Social Challenges
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.
Read more
- 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.
Read the detailed 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:
- Group 1: CLR-Pathways Intervention with mutual gaze strategies.
- 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:
- Baseline: Within two weeks before starting the intervention.
- Post-Intervention: Within two weeks after completing the intervention.
- 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.
- Conditions
- Autism
- Being tested
- Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze, Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention
- Keywords
- Autism Intervention, Cultural and Linguistic Responsivity, Social development, Social communication, Hispanic
- Medical subject headings
- Autistic Disorder, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual GazeBehavioural
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 Parent-Mediated InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Triadic joint attention will be measured using the Joint Engagement Rating Inventory (JERI; Adamson et al., 2020). Supported and Coordinated Joint Engagement subscales of the JERI will be used to capture the quantity and quality of the child paying active attention to both the parent and the shared object. They are scored using a 7-point Likert scale (with 1 indicating no episodes of supported or coordinated joint engagement, respectively). These measures 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 triadic joint attention.
Measured: 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
Social connectedness will be measured using the Fluency and Connectedness item of the Joint Engagement Rating Inventory (JERI; Adamson et al., 2020). Fluency and connectedness captures the flow of a dyad's interaction; it is scored using a 7-point Likert scale (with 1 indicating no episodes of coordinated joint engagement). 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 connectedness.
Measured: 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
Proportion of Grammaticality will be calculated using the Systematic Analysis of Language Transcripts (SALT; Miller \& Iglesias, 2020) software. This captures the ability to conjugate verbs and use sentence structure grammatically. 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start22 Sep 2025
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas at Dallas
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, Catholic Charities, University of Kansas
- Responsible party
- Principal investigator, Pamela Rollins, The University of Texas at Dallas
- Investigators
- Pamela Rollins, EdD, Principal investigator, The University of Texas at Dallas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733584
- Sponsor's protocol ID
- UTD IRB-24-306
- Other IDs
- HT94252410184 / AR230003
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2024
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The shared data will include de-identified demographic data and item-level data from measures administered to participants, as well as analyzed data.
Publications
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.
PubMed 25907978Greenwood 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.
PubMed 24882940Hamilton 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.
PubMed 21749974Zimmerman, I. L., Steiner, V. G., & Pond, R. E. (2011). Preschool language scales (5th ed.). Pearson.
Sparrow S. S., Cicchetti D. V., Balla D. A. (2005). Vineland Adaptive Behavior Scales, Second Edition (Vineland-II). San Antonio, TX: Pearson.
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.
PubMed 38842669Rollins 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.
PubMed 35797775Rollins 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.
PubMed 32894382
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Meeting the Needs of Young Hispanic Autistic Children: Developing a Culturally and Linguistically Sensitive Intervention to Alleviate Core Social Challenges
- ClinicalTrials.gov ID
- NCT06733584
- Acronym / sponsor ID
- UTD IRB-24-306
- Conditions
- Autism
- Keywords
- Autism Intervention, Cultural and Linguistic Responsivity, Social development, Social communication, Hispanic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas at DallasUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs, Catholic Charities, University of Kansas
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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:
- Group 1: CLR-Pathways Intervention with mutual gaze strategies.
- 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:
- Baseline: Within two weeks before starting the intervention.
- Post-Intervention: Within two weeks after completing the intervention.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally and Linguistically Responsive Pathways with a Mutual Gaze Protocol | Experimental | Behavioral: Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention16 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. |
| Culturally and Linguistically Responsive Pathways without Mutual Gaze Protocol | Active comparator | Behavioral: Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze16 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. |
Who may qualify
- Ages
- 18 to 42 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual GazePathways-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. | Behavioural | Culturally and Linguistically Responsive Pathways without Mutual Gaze Protocol |
| Culturally and Linguistically Responsive Pathways Parent-Mediated InterventionPathways-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. | Behavioural | Culturally and Linguistically Responsive Pathways with a Mutual Gaze Protocol |
Primary outcome
Change in Respeto
Time frame: 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
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.
Change in Social Communication Skills
Time frame: 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 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.
Change in Adaptive Functioning
Time frame: 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 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.
Change in Social Attention
Time frame: 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
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.
Change in Intentional Communication
Time frame: 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
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.
Change in Expressive Language
Time frame: 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
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.
3 secondary outcomes
Change in Triadic Joint Attention
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Background: PubMed 25907978Rollins 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.
- Background: PubMed 24882940Greenwood 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.
- Background: PubMed 21749974Hamilton 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.
- BackgroundZimmerman, I. L., Steiner, V. G., & Pond, R. E. (2011). Preschool language scales (5th ed.). Pearson.
- BackgroundSparrow S. S., Cicchetti D. V., Balla D. A. (2005). Vineland Adaptive Behavior Scales, Second Edition (Vineland-II). San Antonio, TX: Pearson.
- Background: PubMed 38842669Kosloski 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.
- Background: PubMed 35797775Rollins 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.
- Background: PubMed 32894382Rollins 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.
- This is the manual for the Joint Engagement Rating Inventory. \[Adamson, L.B., Bakeman, R., \& Suma, K. (2020). The joint engagement rating inventory. Department of Psychology, Georgia State University.\]Link provided by the sponsor.
- This is the link to the Bayley Scales of Infant and Toddler Development, Fourth Edition. \[Bayley, N., \& Aylward, G. P. (2019). Bayley Scales of Infant and Toddler Development (4th ed.). Pearson.\]Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The shared data will include de-identified demographic data and item-level data from measures administered to participants, as well as analyzed data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erin E Kosloski, BA contact
Pamela Rollins, EdD principal investigator
The University of Texas at Dallas
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze and Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention in people with Autism, run by The University of Texas at Dallas at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pamela Rollins, EdD (972-883-3153, rollins@utdallas.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Respeto (time frame: 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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06733584, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.