Trial of an Online Spanish Pivotal Response Treatment Tra... | NCT06690255

Studies
Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder

NCT06690255

Sponsor

Stanford University

Status

Recruiting

Last Update Posted

Jun 22, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Autism Spectrum Disorder

Interventions

Pivotal Response Treatment

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 17, 2026Actual

Primary Completion Date

Dec 15, 2029Estimated

Completion Date

Dec 15, 2030Estimated

First Submitted Date

Nov 13, 2024

First Submission Date that Met QC Criteria

Nov 13, 2024

First Posted Date

Nov 15, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 17, 2026

Last Update Posted Date

Jun 22, 2026Actual

Name	Class
University of California, Santa Barbara	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Spanish PRT Online	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pivotal Response Treatment	Behavioral	PRT will target functional communication abilities	Spanish PRT Online

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Years

Maximum Age

5 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Grace Gengoux, Ph.D.	Contact	6507235511		ggengoux@stanford.edu
Ty Vernon, Ph.D.	Contact			tyvernon@ucsb.edu

Overall Officials

Name	Affiliation	Role
Grace Gengoux, Ph.D.	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stanford University	Recruiting	Palo Alto	California	94305	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders