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New treatment option for Autism Spectrum Disorder
Official title Trial of an Online Spanish Pivotal Response Treatment Training in Autism Spectrum Disorder
ClinicalTrials.gov ID: NCT06690255
What this study is testing
- What it's testing
- 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.
- Time commitment: about 12 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 5
You may be able to join if
- 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...
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Palo Alto, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 12 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 5 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palo Alto, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.