Meeting the Needs of Young Hispanic Autistic Children
ConditionAutism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-42
SponsorThe University of Texas at Dallas
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Culturally and Linguistically Responsive Pathways Parent-Mediated Intervention without Mutual Gaze
BehavioralPathways-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
BehavioralPathways-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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Culturally and Linguistically Responsive Pathways with a Mutual Gaze ProtocolExperimental treatment 1 intervention
Group B: Culturally and Linguistically Responsive Pathways without Mutual Gaze ProtocolActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-up2
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-up3
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-up4
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-upSecondary outcomes
1
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-up2
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-up3
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-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
The University of Texas at Dallas
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Catholic Charities
Collaborator
University of Kansas
Collaborator
Source ClinicalTrials.gov