Pivotal Response Training for Autism

(PRT-C Trial)

Overseen By Anna Oft, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe psychiatric disorder, Unstable seizure, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 13 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the effectiveness of Pivotal Response Treatment (PRT-C) in improving social communication skills in young children with autism. Children will either receive intensive therapy sessions in a center-based setting or continue with their usual treatment, with the option to try PRT-C later. Suitable participants have a confirmed autism diagnosis, are between 2 and 3 years and 11 months old, and have a parent available for training sessions. As an unphased trial, this study provides families with a unique opportunity to explore innovative treatment options for their children.

Will I have to stop taking my current medications?

The trial requires that participants have stable treatment, including medications, for at least 1 month before starting and no changes are expected during the study. So, you should not stop taking your current medications.

What prior data suggests that Pivotal Response Treatment (PRT-C) is safe for children with autism spectrum disorder?

Research has shown that Pivotal Response Treatment (PRT) is an effective therapy for children with autism spectrum disorder (ASD). This treatment, based on applied behavior analysis (ABA), uses rewards to encourage positive behavior.

For many years, PRT has helped children with ASD enhance their social and communication skills. The therapy targets key areas affected by autism, such as social interaction and communication. Studies have found that children generally respond well to PRT.

Negative effects are rare because PRT is a play-based therapy led by the child. The child selects the activities, making sessions more enjoyable and engaging.

Overall, PRT is considered safe for children with autism and has a strong history of improving communication and social skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Pivotal Response Treatment for Autism because it offers an intensive, structured approach that actively involves both the child and their parents. Unlike traditional autism therapies, which might focus solely on the child or use less frequent sessions, this treatment combines 12 weekly hours of center-based therapy for the child with a weekly parent training session. This dual approach not only aims to improve the child's communication and social skills but also empowers parents with strategies to support their child's development, potentially leading to more consistent and lasting improvements.

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

Research has shown that Pivotal Response Treatment (PRT) can improve social communication skills in children with autism. PRT is a therapy that uses everyday situations to teach new skills, and studies indicate it can enhance social and emotional behaviors. The goal is to increase children's motivation and help them apply what they learn in therapy to their daily lives. In this trial, participants will join either the Intensive Center-Based Pivotal Response Treatment (PRT-C) group or the Delayed Treatment Group (DTG). However, some reviews found that PRT did not clearly improve communication or language skills. Overall, PRT is considered a promising method for helping children with autism improve certain behaviors. ^{1 2 3 6 7}

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 preschoolers aged 2 to almost 4 years with Autism Spectrum Disorder (ASD), who have a developmental delay and are English-speaking. They should be on stable treatment without changes expected during the study, and must not have had an adequate trial of Pivotal Response Treatment before.

Inclusion Criteria

I have an English-speaking parent available for training and research.

My current treatment for behavior or speech issues has been stable for at least 1 month.

My child is between 2 and 3 years and 11 months old.

Exclusion Criteria

Child primary language other than English

I have a serious health issue like uncontrolled seizures or heart disease.

You have been diagnosed with a serious mental health condition like bipolar disorder, either currently or in the past.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Intensive Center-Based Pivotal Response Treatment (PRT-C) consisting of one weekly 60-minute individual parent training session and 12 weekly hours with the child in a center-based therapy environment

13 weeks

4 visits per week (in-person)

Delayed Treatment Group (DTG)

Participants receive treatment as usual, with the option to receive PRT-C in a preschool setting after the controlled phase

Duration not specified

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 (PRT-C)

Trial Overview The effectiveness of intensive center-based Pivotal Response Training (PRT-C) is being tested to improve social communication in children with ASD. The study will observe how this specific setting influences the progress made by participants.

How Is the Trial Designed?

Group I: Intensive Center-Based Pivotal Response Treatment (PRT-C) Experimental Treatment 1 Intervention

Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of one weekly 60-minute individual parent training session and 12 weekly hours ( 3 hours per day for 4 days per week) with the child in center-based therapy environment for a total of 13 weekly treatment hours.

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

Delayed Treatment Group will consist of treatment as usual. At the end of controlled phase, participants in the DTG will be offered PRT-C in a preschool setting in an open-label fashion with a design similar to the double-blind phase.

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

Approved in United States as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)

Approved in European Union as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)

Approved in Canada as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

John & Marcia Goldman Foundation

Collaborator

Trials

2

Recruited

120+

Published Research Related to This Trial

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]

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 pilot study involving seven teachers and students with autism spectrum disorder (ASD) found that training in classroom pivotal response teaching (CPRT) did not significantly improve teachers' implementation fidelity or students' communication skills and maladaptive behaviors.

Despite the lack of measurable improvements in student outcomes, teachers expressed high satisfaction with the CPRT training, suggesting that while the training may not have led to immediate changes, it could still be valuable for educators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Teachers to Implement Classroom Pivotal Response Teaching during Small-group Instruction: A Pilot Study. Verschuur, R., Huskens, B., Didden, R.[2021]

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 Training (PRT) has shown statistically significant effects in improving language and communication skills for individuals with autism spectrum disorder (ASD), based on a systematic review of 10 randomized controlled trials (RCTs).

While PRT demonstrates promise for language outcomes, the evidence for its effectiveness in other areas is less consistent, highlighting the need for improved study designs to better understand treatment responses and develop tailored guidelines for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Examining Effectiveness and Predictors of Treatment Response of Pivotal Response Treatment in Autism: An Umbrella Review and a Meta-Analysis. Uljarević, M., Billingham, W., Cooper, MN., et al.[2022]

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]

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. 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 ...

4. 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.

5. link.springer.com link.springer.com/article/10.1007/s40489-013-0008-z

Pivotal Response Treatment for Children with Autism ... Another synthesis of research on PRT concluded that PRT effectively improved social and emotional behaviors of young children with ASD (Masiello ...

6. autismspeaks.org autismspeaks.org/pivotal-response-treatment-prt

Pivotal Response Treatment (PRT) Pivotal Response Treatment, or PRT, is a behavioral treatment for autism. This therapy is play-based and initiated by the child.

7. research.chop.edu research.chop.edu/car-autism-roadmap/pivotal-response-treatment-prt

Pivotal Response Treatment (PRT) Pivotal Response Treatment ® (PRT) is a behaviorally-based intervention designed specifically for children on the autism spectrum.