Clinical trial NCT06690255: Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder
Official title: Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder (PRT-OS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: University of California, Santa Barbara
First posted: 2024-11-15
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in Parent Fidelity of PRT Implementation from Baseline to Week 12
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Change in Child Frequency of Functional Utterances from Baseline to Week 12
timeFrame: Baseline, Week 12
measure: Change in Child Frequency of Functional Utterances from Baseline to Week 12
timeFrame: Baseline, Week 12
measure: Change in Child Socialization and Communication from Baseline to Week 12
timeFrame: Baseline, Week 12
measure: Change in Child Socialization and Communication from Baseline to Week 12
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
Study officials:
References: