Pivotal Response Treatment for Autism

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Claustrophobia, Head injury, Neurological illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 9 weeks

76 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Pivotal Response Treatment (PRT) can improve social skills and behavior in highly verbal teens with autism spectrum disorder (ASD). Researchers will also monitor changes in brain activity. Participants will be divided into two groups: one will begin PRT immediately, while the other will start after a nine-week delay. Teens with ASD who speak English, reside in the San Francisco Bay Area, and wish to improve their social skills may be suitable candidates.

As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could enhance social skills and behavior in teens with ASD.

Will I have to stop taking my current medications?

The trial requires that any current treatments, including medications, must be stable for at least 1 month before starting and should not change during the study.

What prior data suggests that Pivotal Response Treatment for Adolescents is safe?

Research shows that Pivotal Response Treatment (PRT) is generally well-tolerated by people with autism spectrum disorder (ASD). This therapy helps improve social communication skills. Studies have found it effectively assists with first words, social interaction, and language development in individuals with ASD.

While specific side effects are not detailed in the sources, PRT is based on applied behavior analysis, which focuses on teaching new skills and behaviors. This method usually involves rewarding positive behavior, making it safe for children and teenagers with autism.

Overall, PRT is a well-established and evidence-based treatment, indicating minimal risk to participants when used correctly. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Pivotal Response Treatment (PRT) for adolescents with autism because it focuses on enhancing social skills through naturalistic interventions. Unlike traditional therapies, which might involve more structured and less interactive approaches, PRT uses motivational techniques and is integrated into the child's daily life, making learning opportunities more spontaneous and relevant. This approach can lead to more genuine social interactions and improvements in communication skills, potentially offering a more engaging and effective alternative to existing treatments like Applied Behavior Analysis (ABA) or speech therapy.

What evidence suggests that PRT for Adolescents might be an effective treatment for autism?

Research shows that Pivotal Response Treatment (PRT) can improve social communication skills in people with autism spectrum disorder (ASD). Studies have found that PRT leads to positive changes in behavior and social skills by boosting motivation and encouraging social interactions. This trial will compare two groups: the PRT Treatment Group, where participants receive a 9-week PRT intervention, and the Delayed Treatment Group, which receives the intervention after a 9-week delay. This method has been effective for people with ASD of different ages, including teenagers. However, some studies suggest that PRT might not significantly improve communication or language skills for all children with ASD. Overall, PRT is seen as a promising way to enhance social skills in individuals with ASD. ^{1 2 3 5 6}

Who Is on the Research Team?

Dani A Abrams, Ph.D.

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for right-handed, English-speaking adolescents with high-functioning autism in the San Francisco Bay Area. They must have an IQ over 80 and be stable on current treatments with no metal in their body. Participants should want to improve social skills and have scored low on specific social target areas.

Inclusion Criteria

First language is English

Diagnosis of ASD using ADOS-2 and ADI-R

No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period

Exclusion Criteria

I have never had a serious head injury, neurological illness, was not born under 4 lb or before 34 weeks, and I'm not claustrophobic.

Left-handed

Braces or any metal in their body

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-intervention Assessment

Participants undergo pre-intervention MRI brain scan and behavioral assessments

1 week

1 visit (in-person)

Treatment

Participants receive Pivotal Response Treatment (PRT) for 9 weeks to improve social skills

9 weeks

Weekly visits (in-person)

Post-intervention Assessment

Participants complete a second MRI brain imaging session and post-measure appointments

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

1-2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• PRT for Adolescents

Trial Overview The study tests Pivotal Response Treatment (PRT) for Adolescents, focusing on enhancing behavioral and social functions. It also examines changes in brain activity related to this treatment using MRI scans over a period of 9 weeks.

How Is the Trial Designed?

Group I: PRT Treatment Group Experimental Treatment 1 Intervention

After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. Participants in the PRT Treatment Group will complete an 9-week intervention, PRT for Adolescents, to improve the adolescent's social skills. Following the completion of the 9-week intervention, participants will be asked to complete a second MRI brain imaging session, followed by post-measure appointments in order to assess immediate effects of the intervention.

Group II: Delayed Treatment Group Experimental Treatment 1 Intervention

After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. After 9-weeks without any intervention, participants in the Delayed Treatment Group will be asked to complete a second MRI brain imaging session, followed by post-measure appointments, and will then receive the PRT intervention at the end of the study.

PRT for Adolescents is already approved in United States for the following indications:

Approved in United States as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)
• Improvement in behavioral and social function

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

The six-week parent training program for Pivotal Response Treatment (PRT) effectively taught four parents to implement the intervention with high fidelity, enhancing their interactions with their children with autism spectrum disorder (ASD).

Parents reported high satisfaction with the program, indicating that PRT parent training is a promising, efficient, and cost-effective treatment model for improving parent-child interactions in ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Parent-Implemented Pivotal Response Treatment for Children with Autism Spectrum Disorder. Bozkus-Genc, G., Yucesoy-Ozkan, S.[2023]

Pivotal response treatment (PRT) has been shown to be an effective intervention for improving communication and social functioning in children with autism spectrum disorder (ASD), based on a systematic evaluation of 17 studies.

The studies demonstrated strong adherence to several research quality standards, such as using standardized protocols and objective evaluators, but showed variability in treatment fidelity and the use of longitudinal designs, indicating areas for improvement in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal response treatment for children with autism spectrum disorder: a systematic review of research quality. Cadogan, S., McCrimmon, AW.[2018]

In a randomized controlled trial involving 44 children with Autism Spectrum Disorder (ASD), Pivotal Response Treatment (PRT) led to significant improvements in social-communicative skills after 12 weeks compared to treatment-as-usual (TAU).

PRT also showed larger gains in global functioning and adaptive socialization skills, indicating its potential effectiveness as a therapeutic intervention for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal Response Treatment for School-Aged Children and Adolescents with Autism Spectrum Disorder: A Randomized Controlled Trial. de Korte, MWP., van den Berk-Smeekens, I., Buitelaar, JK., et al.[2021]

Pivotal Response Treatment (PRT) significantly improved primary language functions (requesting, labeling, repeating, responding) in 30 autistic children over an 8-week period compared to a control group that only received standard treatment.

The benefits of PRT extended beyond language, enhancing social communication, cognition, motor skills, imitation, and adaptive behaviors, indicating its broad effectiveness in supporting autistic children's development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Pivotal Response Treatment to Improve Language Functions of Autistic Children in Special Schools: A Randomized Controlled Trial. Wang, L., Li, S., Wang, C.[2023]

Pivotal Response Treatment (PRT) has been shown to be effective for preschool-aged children with autism spectrum disorders (ASD), leading to significant improvements in social communication and adaptive skills over a 4-month treatment period.

While the children demonstrated substantial gains, the degree of improvement varied across different measures, indicating that while PRT is beneficial, responses may differ among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improvements in social and adaptive functioning following short-duration PRT program: a clinical replication. Ventola, P., Friedman, HE., Anderson, LC., et al.[2021]

In a quasi-experimental trial involving 24 children with autism spectrum disorder (ASD) aged 3-8 years, those receiving Pivotal Response Treatment (PRT) showed improvement in autism symptoms compared to those receiving treatment as usual (TAU), with a small effect size.

The study found no significant changes in general problem behavior or parental stress levels for either group, indicating that while PRT may enhance autism symptom management, it does not necessarily affect other related challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Pivotal Response Treatment in Children with Autism Spectrum Disorders: A Non-randomized Study with a Blinded Outcome Measure. Duifhuis, EA., den Boer, JC., Doornbos, A., et al.[2019]

A randomized controlled trial involving 53 children with autism showed that parents trained in Pivotal Response Treatment (PRT) significantly improved their children's language skills compared to those in a psychoeducation group, with a notable increase in the frequency of child utterances.

The study demonstrated that 84% of parents in the PRT group effectively learned and implemented the techniques, leading to enhanced adaptive communication skills in their children, highlighting the efficacy of PRT as a parent training model for addressing language deficits in young children with autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. Hardan, AY., Gengoux, GW., Berquist, KL., et al.[2022]

The online model of Pivotal Response Treatment (PRT) delivered through the MindNest Health platform showed good feasibility, with 58% of participants completing the study curriculum, indicating that parents found the online training manageable and engaging.

Parents who participated in the online training reported significant improvements in their confidence and perceptions of treatment effectiveness, with 82% agreeing that the intervention was acceptable, suggesting that this telehealth approach could be a valuable resource for families of autistic children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Delivering Pivotal Response Treatment for Autism Spectrum Disorder via Telehealth: Pilot Pre-Post Study. Drapalik, KN., Grodberg, D., Ventola, P.[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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6486148/

Pivotal Response Treatment for autism spectrum disorder (ASD) Pivotal Response Treatment (PRT) is an ABA‐based intervention that focuses on the generalisation of learned skills in the child's natural ...

3. academic.oup.com academic.oup.com/book/60743/chapter/528391127

Pivotal Response Treatment PRT has been effective with individuals with ASD from infancy to adulthood in improving targeted goals as well as other concomitant improvements ...

4. 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 ...

5. psycnet.apa.org psycnet.apa.org/record/2016-27195-004

Pivotal Response Treatment. Pivotal response treatment (PRT) was developed based on the theory of learned helplessness, and procedures were specifically designed to increase motivation.

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

A Pivotal Response Treatment Package for Children With ... WHAT THIS STUDY ADDS: This study reveals the efficacy of a pivotal response treatment package combining parent training and clinician- delivered intervention ...