An interventional study of Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze and Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention in Autism, sponsored by The University of Texas at Dallas. Recruiting at 3 sites in United States. Open to participants aged 18 Months to 42 Months. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by The University of Texas at Dallas · Not applicable, Interventional, and Treatment
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.
What to Expect: Participants will:
Study Description:
Participants: 200 Hispanic autistic children experiencing low income and their caregivers will be randomly assigned to one of two groups in parallel:
Assessments: To track progress and evaluate long-term effects, participants will undergo several culturally and linguistically appropriate assessments at three time points:
Each evaluation will take approximately 2-3 hours and will include:
Child Assessments:
Caregiver Questionnaires:
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.
1,030 studies on the registry are indexed under Autistic Disorder; 266 are open to participants now.
This study's planned enrollment of 200 is above the median of 49 across 811 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →The University of Texas at Dallas is the lead sponsor of 60 studies on the registry; 19 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
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Exclusion Criteria:
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
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
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.
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.
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.
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 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.
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 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.
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 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.
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 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.
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 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.
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 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.
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
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.
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
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.
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
Not enrolling at this site.
Plan to share: Yes — The shared data will include de-identified demographic data and item-level data from measures administered to participants, as well as analyzed data.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
Started Sep 2025 (actual). Primary completion is estimated for Jan 2028, 28 months after the start.
Of 354 non-industry interventional studies with no phase under Autistic Disorder, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 52. This study's planned 28 months is close to that.
Counting every sponsor, half of 366 studies reached it within 26 months; a quarter within 13 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
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