Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder (PRT-OS)

Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder (PRT-OS)

The goal of this clinical trial is to understand if an online course in Spanish can help Spanish-speaking parents use Pivotal Response Treatment (PRT) to support language and social skills in young children with Autism Spectrum Disorder (ASD). This study aims to reach families who may have trouble accessing autism services due to language, location, or cost barriers. The main questions it hopes to answer are:

• Can Spanish-speaking parents learn to effectively use PRT techniques to support their child's communication?
• Does this training improve children's language and social interactions?

Researchers will evaluate the effectiveness of the online course for parents who participate in regular virtual check-ins and submit videos showing their practice with PRT.

Participants in the study will:

• Complete online lessons over 12 weeks that teach PRT methods, specifically designed for Spanish-speaking parents
• Meet with a research team member every few weeks by phone or video to ask questions and receive feedback
• Provide video recordings of interactions with their child to track progress
• Complete brief surveys about their experience and child's communication abilities

By focusing on Spanish-speaking families, this study aims to increase access to effective autism support and reduce gaps in care. Researchers hope the findings will help develop better resources for families facing similar barriers and improve language and social outcomes for children with autism.

Study Overview

• Status: Not yet recruiting
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Behavioral: Pivotal Response Treatment

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grace Gengoux, Ph.D.; Phone Number: 6507235511; Email: ggengoux@stanford.edu
• Study Contact Backup: Name: Ty Vernon, Ph.D.; Email: tyvernon@ucsb.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Children aged 2 to 5 years, 11 months at the time of consent
• Diagnosis of Autism Spectrum Disorder (ASD), confirmed through medical records and/or parent questionnaire
• Significant language delay, indicated by scores 2 standard deviations (SD) below the average for ages 2 and 3, or 3 SD below the average for ages 4 and 5 on the Vineland-3 Communication subscale or Expressive V-scale
• A Spanish-speaking parent or primary caregiver available to consistently participate in study activities and implement PRT in Spanish
• Stable on any psychotropic medications or biomedical interventions for at least 1 month before baseline, with no anticipated changes during the study
• Consistent treatment or intervention services (such as ABA, Floortime, or speech therapy) and stable school placement for at least 1 month before baseline, with no expected changes
• Limited to no more than 60 minutes of one-on-one speech therapy per week

Exclusion Criteria:

• Primary language of the child or parent is not Spanish
• Either the child or parent has a severe psychiatric disorder or an unstable medical condition
• Prior exposure to or adequate trial of Pivotal Response Treatment, resulting in the parent achieving fidelity in PRT implementation at baseline
• The child is currently receiving more than 15 hours of one-on-one Applied Behavior Analysis (ABA) therapy per week

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spanish PRT Online; Participating parents will receive access to a 12-week online course designed to teach Pivotal Response Treatment (PRT) strategies in Spanish. The course includes 10 instructional lessons and check-ins with a researcher via secure videoconference.	Behavioral: Pivotal Response Treatment; PRT will target functional communication abilities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Parent Fidelity of PRT Implementation from Baseline to Week 12	Based on behavioral coding of parent-child interaction videos in the home	Baseline, Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Child Frequency of Functional Utterances from Baseline to Week 12	Based on behavioral coding of parent-child interaction videos in the home and parent report measures	Baseline, Week 12
Change in Child Frequency of Functional Utterances from Baseline to Week 12	Based on parent-report on the MacArthur-Bates Communicative Development Inventories	Baseline, Week 12
Change in Child Socialization and Communication from Baseline to Week 12	Based on clinician-rated Clinical Global Impressions Scale (CGI)	Baseline, Week 12
Change in Child Socialization and Communication from Baseline to Week 12	Based on parent-rated Vineland Adaptive Behavior Scale, Third Edition (VABS-3)	Baseline, Week 12

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: University of California, Santa Barbara
• Investigators: Principal Investigator: Grace Gengoux, Ph.D., Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 15, 2029
• Study Completion (Estimated): December 15, 2030

Study Registration Dates

• First Submitted: November 13, 2024
• First Submitted That Met QC Criteria: November 13, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: IRB-77671

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No