44 Participants Needed

Pivotal Response Training for Autism

(PRT-C Trial)

EM
MC
AO
Overseen ByAnna Oft, BS
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

The purpose of this study is to examine the effectiveness of pivotal response training (PRT) in an intensive center-based environment to treat social communication deficits in children with autism spectrum disorder (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 are expected during the study. So, you should not stop taking your current medications.

What data supports the effectiveness of the treatment Pivotal Response Treatment (PRT-C) for autism?

Research shows that Pivotal Response Treatment (PRT) can effectively improve communication and social skills in children with autism. Studies have found that children receiving PRT showed greater improvements in social-communicative skills and overall functioning compared to those receiving usual treatments.12345

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

Pivotal Response Treatment (PRT) is unique because it is a naturalistic behavioral intervention that focuses on improving communication and social skills in children with autism by targeting pivotal areas of a child's development, such as motivation and response to multiple cues. Unlike some other treatments, PRT is designed to be flexible and can be integrated into everyday activities, making it more adaptable to individual needs and settings.12367

Research Team

Antonio Hardan, M.D. | Stanford Medicine

Antonio Hardan, MD

Principal Investigator

Stanford University

Eligibility Criteria

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.
See 3 more

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.
See 2 more

Timeline

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

Treatment Details

Interventions

  • Pivotal Response Treatment (PRT-C)
Trial OverviewThe 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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intensive Center-Based Pivotal Response Treatment (PRT-C)Experimental Treatment1 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 Control1 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)

Find a Clinic Near You

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+

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.
Pivotal response treatment for children with autism spectrum disorder: a systematic review of research quality.Cadogan, S., McCrimmon, AW.[2018]
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.
A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism.Hardan, AY., Gengoux, GW., Berquist, KL., et al.[2022]
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.
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]

References

Pivotal response treatment for children with autism spectrum disorder: a systematic review of research quality. [2018]
A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. [2022]
Pivotal Response Treatment for School-Aged Children and Adolescents with Autism Spectrum Disorder: A Randomized Controlled Trial. [2021]
Feasibility and Acceptability of Delivering Pivotal Response Treatment for Autism Spectrum Disorder via Telehealth: Pilot Pre-Post Study. [2023]
The Effect of Pivotal Response Treatment in Children with Autism Spectrum Disorders: A Non-randomized Study with a Blinded Outcome Measure. [2019]
Examining Effectiveness and Predictors of Treatment Response of Pivotal Response Treatment in Autism: An Umbrella Review and a Meta-Analysis. [2022]
Training Teachers to Implement Classroom Pivotal Response Teaching during Small-group Instruction: A Pilot Study. [2021]