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NCT Number: NCT06690255

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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Palo Alto, California, 94305, United States

Location status: Recruiting

Location contact

Grace Gengoux, PhD

PRINCIPAL_INVESTIGATOR

Robin Libove

CONTACT

[email protected]

650-736-1235

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pivotal Response Treatment

Behavioral

PRT will target functional communication abilities

Primary outcomes

  1. Change in Parent Fidelity of PRT Implementation from Baseline to Week 12

    Time frame: Baseline, Week 12

    Based on behavioral coding of parent-child interaction videos in the home

Secondary outcomes

  1. Change in Child Frequency of Functional Utterances from Baseline to Week 12

    Time frame: Baseline, Week 12

    Based on behavioral coding of parent-child interaction videos in the home and parent report measures

  2. Change in Child Frequency of Functional Utterances from Baseline to Week 12

    Time frame: Baseline, Week 12

    Based on parent-report on the MacArthur-Bates Communicative Development Inventories

  3. Change in Child Socialization and Communication from Baseline to Week 12

    Time frame: Baseline, Week 12

    Based on clinician-rated Clinical Global Impressions Scale (CGI)

  4. Change in Child Socialization and Communication from Baseline to Week 12

    Time frame: Baseline, Week 12

    Based on parent-rated Vineland Adaptive Behavior Scale, Third Edition (VABS-3)

Study contacts

Contact information is provided by the study sponsor or research team.

Grace Gengoux, Ph.D.

CONTACT

[email protected]

6507235511

Ty Vernon, Ph.D.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • University of California, Santa Barbara

Registry information

Official study title

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

Acronym: PRT-OS

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Nov 15, 2024
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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