Pivotal Response Treatment for Autism

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Claustrophobia, Head injury, Neurological illness, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 9 weeks

76 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to identify improvement in behavioral and social function and changes in the brain following Pivotal Response Treatment (PRT) for Adolescents in highly verbal adolescents with autism spectrum disorder (ASD).

Will I have to stop taking my current medications?

The trial requires that any current treatments, including medications, must be stable for at least 1 month before starting and should not change during the study.

What data supports the effectiveness of the treatment Pivotal Response Treatment for Adolescents with Autism?

Research shows that Pivotal Response Treatment (PRT) can significantly improve social communication skills in children and adolescents with autism. In a study, children who received PRT showed greater improvements in social skills and attention compared to those who received usual treatment. ^{1 2 3 4 5}

Is Pivotal Response Treatment (PRT) safe for humans?

The research articles reviewed focus on the effectiveness of Pivotal Response Treatment (PRT) for autism spectrum disorder (ASD) and do not specifically address safety concerns, but PRT is generally considered a well-established and accepted behavioral intervention for ASD. ^{1 3 4 6 7}

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

Pivotal Response Treatment (PRT) is unique because it is a naturalistic and evidence-based intervention that focuses on improving social communication by targeting pivotal areas of a child's development, such as motivation and response to multiple cues. Unlike some other treatments, PRT can be delivered by parents and is adaptable to telehealth, making it more accessible and flexible for families. ^{1 3 4 5 8}

Research Team

Dani A Abrams, Ph.D.

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for right-handed, English-speaking adolescents with high-functioning autism in the San Francisco Bay Area. They must have an IQ over 80 and be stable on current treatments with no metal in their body. Participants should want to improve social skills and have scored low on specific social target areas.

Inclusion Criteria

First language is English

Diagnosis of ASD using ADOS-2 and ADI-R

No evidence of significant difficulty during pregnancy, labor, delivery, or immediate neonatal period

Exclusion Criteria

I have never had a serious head injury, neurological illness, was not born under 4 lb or before 34 weeks, and I'm not claustrophobic.

Left-handed

Braces or any metal in their body

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Pre-intervention Assessment

Participants undergo pre-intervention MRI brain scan and behavioral assessments

1 week

1 visit (in-person)

Treatment

Participants receive Pivotal Response Treatment (PRT) for 9 weeks to improve social skills

9 weeks

Weekly visits (in-person)

Post-intervention Assessment

Participants complete a second MRI brain imaging session and post-measure appointments

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2-4 weeks

1-2 visits (in-person)

Treatment Details

Interventions

• PRT for Adolescents

Trial Overview The study tests Pivotal Response Treatment (PRT) for Adolescents, focusing on enhancing behavioral and social functions. It also examines changes in brain activity related to this treatment using MRI scans over a period of 9 weeks.

Participant Groups

Group I: PRT Treatment Group Experimental Treatment 1 Intervention

After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. Participants in the PRT Treatment Group will complete an 9-week intervention, PRT for Adolescents, to improve the adolescent's social skills. Following the completion of the 9-week intervention, participants will be asked to complete a second MRI brain imaging session, followed by post-measure appointments in order to assess immediate effects of the intervention.

Group II: Delayed Treatment Group Experimental Treatment 1 Intervention

After study participants have completed screenings to meet our inclusion criteria, participants will take part in the pre-intervention MRI brain scan and behavioral assessments and will then be assigned randomly to one of two arms of intervention for 9 weeks. After 9-weeks without any intervention, participants in the Delayed Treatment Group will be asked to complete a second MRI brain imaging session, followed by post-measure appointments, and will then receive the PRT intervention at the end of the study.

PRT for Adolescents is already approved in United States for the following indications:

Approved in United States as Pivotal Response Treatment for:

• Autism Spectrum Disorder (ASD)
• Improvement in behavioral and social function

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

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]

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]

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]

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]

The six-week parent training program for Pivotal Response Treatment (PRT) effectively taught four parents to implement the intervention with high fidelity, enhancing their interactions with their children with autism spectrum disorder (ASD).

Parents reported high satisfaction with the program, indicating that PRT parent training is a promising, efficient, and cost-effective treatment model for improving parent-child interactions in ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Parent-Implemented Pivotal Response Treatment for Children with Autism Spectrum Disorder. Bozkus-Genc, G., Yucesoy-Ozkan, S.[2023]

Pivotal Response Treatment (PRT) significantly improved primary language functions (requesting, labeling, repeating, responding) in 30 autistic children over an 8-week period compared to a control group that only received standard treatment.

The benefits of PRT extended beyond language, enhancing social communication, cognition, motor skills, imitation, and adaptive behaviors, indicating its broad effectiveness in supporting autistic children's development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Pivotal Response Treatment to Improve Language Functions of Autistic Children in Special Schools: A Randomized Controlled Trial. Wang, L., Li, S., Wang, C.[2023]

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. United States 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. [2019]

3. England pubmed.ncbi.nlm.nih.gov

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

4. 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]

5. 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]

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

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

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

Efficacy of a Parent-Implemented Pivotal Response Treatment for Children with Autism Spectrum Disorder. [2023]

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

Using Pivotal Response Treatment to Improve Language Functions of Autistic Children in Special Schools: A Randomized Controlled Trial. [2023]