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

Trial Summary

What is the purpose of this trial?

The aim of this clinical trial is to compare the efficacy of a 16-week center-based Pivotal Response Treatment (PRT-C) versus home-based Pivotal Response Treatment (PRT-H) in targeting social communication deficits in young children with autism spectrum disorder (ASD) with significant language delay. The two groups will also be compared to a control group that consists of children who are receiving treatment as usual (TAU).

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.

How is Pivotal Response Treatment (PRT) different from other autism treatments?

Pivotal Response Treatment (PRT) is unique because it is a naturalistic, evidence-based therapy that focuses on improving social communication in children with autism by involving parents in the treatment process. Unlike some other therapies, PRT can be delivered in various settings, including at home or via telehealth, making it flexible and accessible. ^{1 2 3 4 5}

Research Team

Antonio Hardan, MD

Principal Investigator

Stanford University

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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) 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

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

2. Canada pubmed.ncbi.nlm.nih.gov

Feasibility and Acceptability of Delivering Pivotal Response Treatment for Autism Spectrum Disorder via Telehealth: Pilot Pre-Post Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Pivotal Response Treatment for School-Aged Children and Adolescents with Autism Spectrum Disorder: A Randomized Controlled Trial. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Improvements in social and adaptive functioning following short-duration PRT program: a clinical replication. [2021]

5. England pubmed.ncbi.nlm.nih.gov

A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. [2022]