Pivotal Response Treatment for Autism

(PRT-I Trial)

Overseen By Estefania Millan, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe psychiatric disorder, Genetic abnormality, Active medical problem, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 16

Duration: 16 weeks

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how young children with autism respond to Pivotal Response Treatment (PRT), a program focused on improving language skills. Researchers seek to identify markers in brain images that might predict a child's response to PRT. Participants will be randomly assigned to either receive the PRT program or continue with their current treatments for a set period. Children aged 2 to 4 with a language delay and a confirmed autism diagnosis, whose parents can actively participate in sessions, may be suitable for this trial. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance autism treatment strategies.

Will I have to stop taking my current medications?

The trial requires that any psychotropic medications or biomedical interventions you are taking must be stable for at least 1 month before starting the study, and you should not expect to change them during the study.

What prior data suggests that Pivotal Response Treatment is safe for children with autism?

Research has shown that Pivotal Response Treatment (PRT) is a well-researched therapy for children with autism. Studies indicate that PRT is generally safe and helps improve social communication skills, with no major safety issues reported.

One study found that PRT significantly improved language and communication skills in many children. Parents participating in a PRT program for their children reported positive experiences and outcomes, suggesting that families and children receive the treatment well.

Overall, PRT has been used in many studies and is considered an evidence-based approach, supported by research and generally safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Pivotal Response Treatment Program (PRT-P) for autism because it emphasizes parent involvement and natural learning opportunities, which is different from many traditional, therapist-led interventions. Unlike standard approaches like Applied Behavior Analysis (ABA) that often rely on structured environments, PRT-P integrates therapy into everyday activities, making it potentially more accessible and less disruptive for families. By empowering parents through dedicated sessions, PRT-P aims to enhance communication and social skills in children with autism in a more engaging and holistic manner.

What evidence suggests that Pivotal Response Treatment might be an effective treatment for autism?

Research has shown that Pivotal Response Treatment (PRT) improves social communication skills in people with autism. In this trial, some participants will receive the Pivotal Response Treatment Program (PRT-P), which includes 3 parent-only sessions and 13 family sessions over 16 weeks. Studies have found that PRT significantly boosts language and communication abilities, leading to more spontaneous speech. Specifically, children receiving PRT demonstrated greater progress in using language in everyday situations compared to a group that started treatment later. PRT targets key areas that enhance both specific and related skills. Overall, strong evidence supports PRT's effectiveness for children with autism. ^{1 3 6 7 8}

Who Is on the Research Team?

Antonio Hardan, MD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children aged 2 to just under 5 with Autism Spectrum Disorder (ASD), who speak English, have a language delay, and can complete testing. They should not be getting more than an hour of speech therapy per week or over 15 hours of in-home ABA. Kids with severe psychiatric disorders, genetic abnormalities like Fragile X, active medical issues like unstable seizures, or previous PRT trials cannot join.

Inclusion Criteria

I have been diagnosed with Autism Spectrum Disorder.

I am between 2 and 4 years old.

My child can follow the testing procedures well enough for accurate results.

Exclusion Criteria

Previous adequate Pivotal Response Treatment (PRT) trial

Magnetic Resonance (MR) contraindication (e.g., the presence of ferrous metal)

I have a genetic condition like Fragile X.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Pivotal Response Treatment Program (PRT-P) consisting of 3 parent-only sessions and 13 family sessions over 16 weeks

16 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pivotal Response Treatment Program (PRT-P)

Trial Overview

The study tests if brain scans before treatment can predict how well young children with ASD respond to Pivotal Response Treatment (PRT-P), which focuses on improving language skills. Participants are randomly assigned to start PRT-P immediately or after a delay.

How Is the Trial Designed?

Group I: Pivotal Response Treatment Program (PRT-P) Experimental Treatment 1 Intervention

The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.

Group II: Delayed Treatment Group (DTG) Active Control 1 Intervention

Child continues stable treatments as usual in the community.

Pivotal Response Treatment Program (PRT-P) is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)
• Language deficits in young children with ASD

Approved in Canada as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)
• Language deficits in young children with ASD

Approved in European Union as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)
• Language deficits in young children with ASD

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Published Research Related to This Trial

Proton beam radiation therapy (PRT) shows promise in maintaining stable neuropsychological functioning in pediatric brain tumor patients compared to traditional photon radiation therapy (XRT), which is associated with declining neuropsychological outcomes over time.

Despite some variability in specific cognitive areas like working memory and processing speed, the evidence suggests that PRT may reduce the risk of neuropsychological issues, although further research is needed to account for medical and sociodemographic differences among patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of pediatric neuropsychological outcomes with proton versus photon radiation therapy: A call for equity in access to treatment. Peterson, RK., King, TZ.[2023]

A study of 48 children with malignant brain tumors treated with proton beam therapy (PBT) showed that acute toxicities were generally low-grade and manageable, with fatigue, alopecia, and dermatitis being the most common side effects.

The research indicates that PBT is well tolerated in pediatric patients, and acute toxicities can be effectively managed with supportive care, suggesting a favorable safety profile for this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity of proton beam radiation for pediatric central nervous system malignancies. Suneja, G., Poorvu, PD., Hill-Kayser, C., et al.[2013]

Pediatric brain tumor survivors treated with craniospinal irradiation (CSI) using proton radiotherapy (PRT) showed significantly worse cognitive and adaptive outcomes compared to those treated with focal PRT, indicating that the extent of radiation exposure impacts cognitive health.

Cognitive performance was found to fully mediate the relationship between the type of radiation field and adaptive functioning, suggesting that efforts to minimize radiation exposure to non-target brain tissue are crucial for improving long-term outcomes in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive mediators of adaptive functioning outcomes in survivors of pediatric brain tumors treated with proton radiotherapy. Roth, AK., Ris, MD., Orobio, J., et al.[2021]

Proton beam therapy (PBT) is feasible for treating infants with central nervous system tumors, showing promising short-term outcomes with a 3-year overall survival rate of 76.5% among 51 infants studied.

However, the treatment is associated with significant logistical challenges and potential for higher-grade toxicities, including late effects like endocrinopathy and hearing loss, highlighting the need for careful monitoring and longer follow-up to assess long-term impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Proton Beam Therapy for Infants with Brain Tumours: Experiences from the Prospective KiProReg Registry Study. Jazmati, D., Steinmeier, T., Ahamd Khalil, D., et al.[2021]

In a study of 595 pediatric patients treated with proton radiation therapy (PBT) for brain tumors, only 3.2% developed symptomatic brainstem injury (SBI), indicating a relatively low risk of this serious complication.

The implementation of strict brainstem dose constraints in 2014 led to a trend of reduced SBI incidence from 4.4% to 1.5%, suggesting that careful dose management can enhance safety without compromising treatment effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying the risk and dosimetric variables of symptomatic brainstem injury after proton beam radiation in pediatric brain tumors. Upadhyay, R., Liao, K., Grosshans, DR., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5488784/

Pivotal response treatment for autism spectrum disorder

PRT is an evidence-based behavioral intervention based on applied behavior analysis principles aimed to improve social communication skills in individuals with ...

2.

frontiersin.org

frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.766150/full

Examining Effectiveness and Predictors of Treatment ...

Statistically significant effects of PRT were identified across a majority of identified RCTs for a range of language and communication skills.

3.

nature.com

nature.com/articles/s41598-022-10604-2

Pivotal Response Treatment (PRT) parent group training ...

Preliminary results showed a significant increase in spontaneous initiations during a semi-structured therapist-child interaction together with ...

4.

med.stanford.edu

med.stanford.edu/content/dam/sm/sasnl/documents/8_peds_20190178.pdf

A Pivotal Response Treatment Package for Children With ...

compared with the delayed treatment group, children in PRT-P demonstrated greater improvement in frequency of functional utterances (F1,41 = 6.07; P = .026; ...

5.

psycnet.apa.org

psycnet.apa.org/record/2023-11669-012

Pivotal Response Treatment (PRT): Research findings over 30 ...

PRT is an evidence-based practice that focuses on key “pivotal” areas to produce improvements in targeted areas as well as untargeted areas.

6.

ies.ed.gov

ies.ed.gov/ncee/wwc/EvidenceSnapshot/668

WWC | Pivotal Response Training

PRT was found to have no discernible effects on communication/language competencies for children and students with an autism spectrum disorder. Pivotal response ...

7.

link.springer.com

link.springer.com/article/10.1007/s10803-021-05397-8

Pivotal Response Treatment (PRT) - Parent Group Training ...

This qualitative study examined the perspectives of parents of young children with ASD who participated in a 14-week PRT with parent group training (PRT-PG).

8.

medicine.yale.edu

medicine.yale.edu/trial/pivotal-response-treatment-for-children-with-autism-spectrum-disorders/

Pivotal Response Treatment for Children With Autism ...

The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with ASD (Pivotal Response ...