Pivotal Response Treatment for Autism

(PRT-HvC Trial)

Overseen By Maddy Clark

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Severe psychiatric disorder, ABA 15+ hours, others

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

Compensation: Varies

Number of Visits: 12

Duration: 16 weeks

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the best way to deliver Pivotal Response Treatment (PRT) for young children with autism spectrum disorder (ASD) who have significant language delays. It compares the effectiveness of therapy provided at a center (Center-Based Pivotal Response Treatment, PRT-C) versus at home (Home-Based Pivotal Response Treatment, PRT-H), and includes a group receiving treatment as usual (TAU) for comparison. The trial seeks children aged 2 to 5 who have been diagnosed with ASD, experience language delays, and have a stable treatment routine. As an unphased trial, this study offers a unique opportunity to enhance understanding of the best treatment delivery methods for young children with ASD.

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 during the study. So, you will not have to stop taking your current medications if they have been stable.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Pivotal Response Treatment (PRT), whether conducted at a center or at home, is generally well-tolerated by young children with autism spectrum disorder (ASD). In past studies, children who received PRT made significant progress in their communication skills, and no major side effects were reported. PRT uses learning techniques to help children improve their social and communication skills. These studies found no serious negative effects, suggesting that both center-based and home-based methods are safe for children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer a personalized approach to enhancing social communication skills in children with autism. Unlike standard treatments, which often involve generic behavioral therapies, these interventions—Center-Based Pivotal Response Treatment (PRT-C) and Home-Based Pivotal Response Treatment (PRT-H)—focus on pivotal areas of a child's development, like motivation and social engagement, through targeted, play-based activities. Additionally, both interventions include parent training, which empowers families to continue the therapy at home, potentially leading to more sustainable improvements. This combination of tailored therapy and active family involvement is what makes these treatments stand out.

What evidence suggests that this trial's treatments could be effective for autism?

Research has shown that Pivotal Response Treatment (PRT) improves social communication skills in children with autism. This trial will compare two methods: center-based PRT (PRT-C) and home-based PRT (PRT-H). Studies have found that both methods significantly enhance language and social interactions. For instance, children receiving PRT often initiate conversations more frequently and communicate more effectively. Evidence suggests that PRT uses motivational techniques to encourage engagement and interaction. Furthermore, when parents receive training alongside clinicians, the positive effects increase. These findings indicate that PRT is a promising approach to enhancing social communication skills in children with autism. ^{1 4 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 young children aged 2 to 5.11 years with autism spectrum disorder (ASD) and a significant language delay, who are receiving no more than an hour of speech therapy per week. They must have stable treatment for at least one month prior and be able to participate in testing procedures. Children with severe psychiatric disorders, unstable medical conditions, or those already having extensive ABA therapy are not eligible.

Inclusion Criteria

My child is between 2 and 5 years old.

Ability to participate in testing procedures to obtain valid standard scores

My treatment has been the same for at least 1 month.

Exclusion Criteria

Living more than 30 miles from Stanford University

Receiving ABA of 15 hours or more

I have a current health issue that needs treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either a 16-week center-based or home-based Pivotal Response Treatment (PRT) intervention, or treatment as usual (TAU)

16 weeks

12 hours per week including 1 hour of parent training

Follow-up

Participants are monitored for changes in social responsiveness and social functioning after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)
• Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)

Trial Overview

The study compares two methods of Pivotal Response Treatment over 16 weeks: one delivered in a center (PRT-C) and the other at home (PRT-H), against usual treatments. It aims to see which setting better improves social communication skills in children with ASD.

How Is the Trial Designed?

Group I: Home-Based Pivotal Response Treatment (PRT) Intervention (PRT-H) Experimental Treatment 1 Intervention

A 16-week home-based PRT intervention (PRT-H) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.

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

A 16-week center-based PRT intervention (PRT-C) consisting of 12 hours per week including 1 hour of parent training. This intervention targets social communication deficits.

Group III: Treatment As Usual (TAU) Active Control 1 Intervention

This is a control group that consists of children who are receiving treatment as usual (TAU) for a 16-week period. These families will be invited to participate in PRT after completing the 16-week TAU phase.

Center-Based Pivotal Response Treatment (PRT) Intervention (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)
• Social Communication Deficits

Approved in European Union as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)
• Social Communication Deficits

Approved in Canada as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)
• Social Communication Deficits

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Anonymous Donor

Collaborator

Trials

1

Recruited

120+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based preschool environment to treat social ...

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