Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
200 participants
INTERVENTIONAL
2025-09-22
2028-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Word Learning in Children With Autism
NCT03419611
Talk With Me Baby: Leveraging Well-Child Care to Enhance the Early Home Language Environment
NCT07132411
Predicting Language and Literacy Growth in Children With ASD Using Statistical Learning
NCT06332144
How Simplified Language Affects Comprehension and Learning in Young Autistic Children
NCT05707923
Let's Know!2: Language-focused Intervention for Children at Risk of Comprehension Difficulties
NCT05133479
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Culturally and Linguistically Responsive Pathways with a Mutual Gaze Protocol
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.
Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention
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 without Mutual Gaze Protocol
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.
Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze
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 Intervention
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
18 Months
42 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Congressionally Directed Medical Research Programs
FED
Catholic Charities
OTHER
University of Kansas
OTHER
The University of Texas at Dallas
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Pamela Rollins
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Pamela Rollins, EdD
Role: PRINCIPAL_INVESTIGATOR
University of Texas at Dallas
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Kansas
Lawrence, Kansas, United States
Catholic Charities of Dallas
Dallas, Texas, United States
University of Texas at Dallas
Richardson, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Sparrow S. S., Cicchetti D. V., Balla D. A. (2005). Vineland Adaptive Behavior Scales, Second Edition (Vineland-II). San Antonio, TX: Pearson.
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.
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.
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.
Zimmerman, I. L., Steiner, V. G., & Pond, R. E. (2011). Preschool language scales (5th ed.). Pearson.
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.
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.
Related Links
Access external resources that provide additional context or updates about the study.
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. \[Wetherby, A., \& Prizant, B. (2002). Communication and Symbolic Behavior Scales- Developmental Profile (1st normed ed.). Paul H. Brookes.\]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HT94252410184 / AR230003
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
UTD IRB-24-306
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.