Behavioral Therapy for Autism

(M-PRT-IS Trial)

Overseen By Robin Libove, BS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-english speaking, Reside outside US, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

44 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants have stable medication for at least two weeks with no expected changes, so you can continue taking your current medications as long as they are stable.

What data supports the effectiveness of the treatment Modified Pivotal Response Treatment, Pivotal Response Treatment, PRT, Natural Language Paradigm (NLP) for autism?

Research shows that Pivotal Response Treatment (PRT) helps improve communication and social skills in children with autism. Studies also indicate that the Natural Language Paradigm (NLP) can increase speech in autistic children when used by trained parents at home. ^{1 2 3 4 5}

Is Pivotal Response Treatment (PRT) safe for humans?

The research on Pivotal Response Treatment (PRT) for autism spectrum disorder does not report any safety concerns, suggesting it is generally safe for use in humans. ^{3 4 5 6 7}

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

Modified Pivotal Response Treatment (PRT) is unique because it uses a naturalistic approach, focusing on motivation and child-led interactions in everyday settings, unlike more structured methods like traditional applied behavior analysis (ABA). This approach has been shown to improve communication and social skills more effectively by incorporating natural reinforcers and allowing children to initiate interactions. ^{4 5 8 9 10}

What is the purpose of this trial?

The purpose of this open label trial is to examine the preliminary feasibility, acceptability, and effectiveness of a 12-week behavioral intervention program (1 hour/week) to treat insistence on sameness (e.g., difficulty tolerating changes in routine) in youth with autism spectrum disorder (ASD). Treatment will be delivered via secure telemedicine platform and consist of a combination of parent-training and parent-mediated intervention with the child.

Research Team

Antonio Hardan, MD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for young people with autism who have a hard time dealing with changes in their routine. They should score high on a specific test for this behavior, be stable on current treatments for two weeks, live in the U.S., and both they and their parents must speak English.

Inclusion Criteria

I am over 18 and my child is between 4 and 17 years old.

English-speaking parent and youth able to consistently participate in study procedures

I have been diagnosed with ASD or suspected to have ASD, confirmed by ADI-R.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week behavioral intervention program delivered via telemedicine, consisting of parent-training and parent-mediated intervention

12 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Treatment Details

Interventions

• Modified Pivotal Response Treatment

Trial Overview The study tests a 12-week program to help autistic youth cope better with change. It involves parent training and child-focused activities delivered online for one hour each week.

Participant Groups

Group I: Remote (Telehealth) Intervention Program Experimental Treatment 1 Intervention

Modified Pivotal Response Treatment 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)
• Insistence on Sameness

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)

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

Findings from Research

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]

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]

The case series highlights the effectiveness of Pivotal Response Treatment (PRT) in two preschool-aged children with autism spectrum disorder (ASD), suggesting a positive trajectory towards an 'optimal outcome' after intensive treatment.

Understanding how children respond to PRT can help tailor individualized treatment programs, enhancing the chances of success for each child based on their unique needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward optimal outcome following pivotal response treatment: a case series. Ventola, PE., Oosting, DR., Keifer, CM., et al.[2020]

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]

Training parents to use the Natural Language Paradigm (NLP) effectively increased the frequency of verbalizations in their nonverbal and echolalic autistic children, demonstrating the method's efficacy.

After initial training in a clinic, parents successfully implemented NLP at home, leading to improvements in their children's speech across various settings, not just during training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training parents to use the natural language paradigm to increase their autistic children's speech. Laski, KE., Charlop, MH., Schreibman, L.[2019]

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]

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 clinical trial comparing pivotal response treatment (PRT) and structured applied behavior analysis (ABA) showed that PRT was significantly more effective in improving communication skills in children with autism spectrum disorder (ASD) after 3 months.

The study highlights the importance of motivational variables in naturalistic teaching methods, suggesting that PRT can lead to faster improvements in both targeted and untargeted communication areas for children with ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized clinical trial comparison between pivotal response treatment (PRT) and structured applied behavior analysis (ABA) intervention for children with autism. Mohammadzaheri, F., Koegel, LK., Rezaee, M., et al.[2021]

A review of 10 controlled studies found that normalized interventions for teaching language to young children with autism were more effective than traditional operant behavioral procedures, particularly in achieving language criterion responses.

Normalized interventions also resulted in more positive parental affect compared to discrete-trial training, suggesting benefits not only for the children but also for their families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparisons of discrete-trial and normalized behavioral language intervention for young children with autism. Delprato, DJ.[2019]

The study focused on three children with autism spectrum disorder (ASD) aged 4 to 6 years and used a natural language paradigm (NLP) combined with time delay to enhance their vocal and augmented requesting skills.

Results showed that the intervention was effective, as all participants increased their spontaneous vocal requests when both vocal and augmented communication methods were available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Naturalistic teaching approach to develop spontaneous vocalizations and augmented communication in children with autism spectrum disorder. Alzrayer, NM., Aldabas, R., Alhossein, A., et al.[2021]

References

1. 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]

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

Toward optimal outcome following pivotal response treatment: a case series. [2020]

4. England pubmed.ncbi.nlm.nih.gov

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

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

Training parents to use the natural language paradigm to increase their autistic children's speech. [2019]

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

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

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

A randomized clinical trial comparison between pivotal response treatment (PRT) and structured applied behavior analysis (ABA) intervention for children with autism. [2021]

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

Comparisons of discrete-trial and normalized behavioral language intervention for young children with autism. [2019]

10. England pubmed.ncbi.nlm.nih.gov

Naturalistic teaching approach to develop spontaneous vocalizations and augmented communication in children with autism spectrum disorder. [2021]