Pivotal Response Training for Autism
(PRT-C Trial)
Recruiting in Palo Alto (17 mi)
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Stanford University
Disqualifiers: Severe psychiatric disorder, Unstable seizure, others
No Placebo Group
Approved in 4 Jurisdictions
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.
12345How 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.
12367Eligibility 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.
+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.
+2 more
Trial 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
Participant Groups
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.
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, Australia 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)
🇦🇺 Approved in Australia as Pivotal Response Treatment for:
- Autism Spectrum Disorder (ASD)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Stanford University School of MedicineStanford, CA
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Who Is Running the Clinical Trial?
Stanford UniversityLead Sponsor
John & Marcia Goldman FoundationCollaborator
References
Pivotal response treatment for children with autism spectrum disorder: a systematic review of research quality. [2018]Research has indicated support for pivotal response treatment (PRT) as an effective, efficacious and naturalistic intervention for communication and social functioning of children with autism spectrum disorder (ASD). Previously not undertaken, this article describes a systematic evaluation of the adherence of PRT research studies to standards of ASD research quality.
A randomized controlled trial of Pivotal Response Treatment Group for parents of children with autism. [2022]With rates of autism diagnosis continuing to rise, there is an urgent need for effective and efficient service delivery models. Pivotal Response Treatment (PRT) is considered an established treatment for autism spectrum disorder (ASD); however, there have been few well-controlled studies with adequate sample size. The aim of this study was to conduct a randomized controlled trial to evaluate PRT parent training group (PRTG) for targeting language deficits in young children with ASD.
Pivotal Response Treatment for School-Aged Children and Adolescents with Autism Spectrum Disorder: A Randomized Controlled Trial. [2021]Pivotal Response Treatment (PRT) is promising for children with Autism Spectrum Disorder (ASD), but more methodologically robust designed studies are needed. In this randomized controlled trial, forty-four children with ASD, aged 9-15 years, were randomly allocated to PRT (n = 22) or treatment-as-usual (TAU; n = 22). Measurements were obtained after 12- and 20-weeks treatment, and 2-month follow-up. PRT resulted in significant greater improvements on parent-rated social-communicative skills after 12 weeks treatment (p = .004, partial η2 = 0.22), compared to TAU. Furthermore, larger gains in PRT compared to TAU were observed on blindly rated global functioning, and parent-rated adaptive socialization skills and attention problems. Implications for clinical practice and suggestions for future research are discussed.
Feasibility and Acceptability of Delivering Pivotal Response Treatment for Autism Spectrum Disorder via Telehealth: Pilot Pre-Post Study. [2023]Pivotal response treatment (PRT), an evidence-based and parent-delivered intervention, is designed to improve social communication in autistic individuals.
The Effect of Pivotal Response Treatment in Children with Autism Spectrum Disorders: A Non-randomized Study with a Blinded Outcome Measure. [2019]Purpose of this quasi-experimental trial was to investigate the effect of Pivotal response treatment (PRT) versus treatment as usual (TAU) on autism symptoms. Children with autism spectrum disorder (ASD), aged 3-8 years, received either PRT (n = 11) or TAU (n = 13). Primary outcome measure was the total score on the Autism Diagnostic Observation Schedule at pre- and posttreatment. Additionally, general problem behavior and parental stress levels were measured. Children in the PRT condition improved on the primary outcome measure compared to the TAU group with a small effect size [partial η2 = 0.22 (95 % CI 0.00-0.46)]. Neither group demonstrated significant changes in the secondary outcomes. This study suggests that PRT may improve autism symptoms in children with ASD over TAU.
Examining Effectiveness and Predictors of Treatment Response of Pivotal Response Treatment in Autism: An Umbrella Review and a Meta-Analysis. [2022]The current study aimed to provide a comprehensive appraisal of the current evidence on the effectiveness of Pivotal Response Training (PRT) for individuals with autism spectrum disorder (ASD) and to explore predictors of treatment response. We conducted a systematic review of the following electronic databases and registers: PsycINFO, Medline, Embase, Cochrane Central Register of Controlled Trials, ERIC, Linguistics and Language Behavior Abstracts. Six systematic reviews were identified, two with meta-analytic component. Identified reviews varied widely in terms of their aims, outcomes, and designs which precluded a unified and consistent set of conclusions and recommendations. Ten RCTs were identified. Eight of identified RCTs reported at least one language and communication-related outcome. Statistically significant effects of PRT were identified across a majority of identified RCTs for a range of language and communication skills. However, evidence for positive treatment effects of PRT on outcome measures assessing other domains was less robust and/or specific. Overall, both previous systematic reviews and new meta-analysis of the RCTs suggest that PRT shows promise for improving language and communication. Only four RCTs examined the association between baseline child characteristics and treatment outcomes, however, no consistent pattern emerged. This review has identified several key methodological and design improvements that are needed to enable our field to fully capitalize on the potential of RCT designs and characterize detailed profiles of treatment responders. These findings are essential for informing the development of evidence-based guidelines for clinicians on what works for whom and why.
Training Teachers to Implement Classroom Pivotal Response Teaching during Small-group Instruction: A Pilot Study. [2021]Background: Providing effective education to students with autism spectrum disorder (ASD) poses a significant challenge to educators. Although several evidence-based practices (EBPs) have been developed, few have been systematically implemented in educational settings. Pivotal response treatment (PRT) is a naturalistic behavioral intervention that has been adapted for implementation in the school context. Methods: This pilot study used a concurrent multiple baseline design across seven teachers and students with ASD to examine the effectiveness of teacher training in classroom pivotal response teaching (CPRT) on teacher fidelity of implementation during small-group instruction and students' communication skills and maladaptive behaviors in schools for special education in the Netherlands. Results: Results indicated no replicated effect of CPRT training on teachers' fidelity of implementation or children's communications skills and maladaptive behavior, although teachers reported high satisfaction with the CPRT training. Discussion: Implications for clinical practice and directions for future research are discussed.