Online Pivotal Response Treatment for Autism

(PRT-O Trial)

Overseen By Estefania Millan, MA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-English, Severe psychiatric, Unstable medical, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

44 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a research study that will assess the effects of a Pivotal Response Treatment Online Training Course (PRT-O) for training parents of children with Autism Spectrum Disorder (ASD). The study will specifically investigate whether participants can learn to deliver PRT effectively following participation in the Online training.

Do I need to stop my current medications for the trial?

No, you don't need to stop your current medications, but they must be stable for at least 1 month before starting the trial and should not change during the study.

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

Research shows that Pivotal Response Treatment (PRT) is effective in improving communication and social skills in children with autism. Studies have found that PRT can be successfully delivered by parents and through online platforms, making it a flexible and accessible option for families. ^{1 2 3 4 5}

Is Pivotal Response Treatment Online (PRT-O) safe for humans?

The available research on Pivotal Response Treatment (PRT) for autism, including its online delivery, does not report any safety concerns, and participants generally express high satisfaction with the treatment. ^{1 2 3 5 6}

How is the Pivotal Response Treatment Online (PRT-O) course different from other autism treatments?

The Pivotal Response Treatment Online (PRT-O) course is unique because it is an online adaptation of Pivotal Response Treatment (PRT), which is a naturalistic behavioral intervention focusing on improving social communication in autistic individuals. Unlike some other treatments, PRT involves significant parent participation and can be delivered via telehealth, making it more accessible and flexible for families. ^{1 2 3 5 7}

Research Team

Grace Gengoux, PhD

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for parents of children with Autism Spectrum Disorder (ASD). It aims to teach them how to deliver Pivotal Response Treatment (PRT) through an online course. Specific eligibility criteria are not provided, but typically participants would need reliable internet access and a commitment to complete the training.

Inclusion Criteria

My mental health medication has been stable for at least 1 month.

I am between 2 and 5 years old.

Stable treatment and school placement for at least 1 month prior to baseline measurements with no expected changes

Exclusion Criteria

I have completed a pivotal response treatment program successfully.

I am getting over 15 hours of one-on-one ABA therapy at home weekly.

Children who have a primary language other than English

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants complete 10 online lessons over a 12-week period, practicing PRT at home

12 weeks

Follow-up

Participants are monitored for changes in Parent Fidelity of PRT Implementation and Child Functional Verbal Utterances

4 weeks

Treatment Details

Interventions

• Pivotal Response Treatment Online (PRT-O) Course

Trial Overview The study is testing the effectiveness of an Online Pivotal Response Treatment Training Course (PRT-O) designed for parents. The goal is to see if parents can learn and apply PRT methods effectively with their ASD-diagnosed children after taking this online course.

Participant Groups

Group I: Pivotal Response Treatment Online (PRT-O) Course Experimental Treatment 1 Intervention

The PRT-O Online Course (PRT-O) will consist of 10 online lessons completed asynchronously through the Stanford LearnMed Online CANVAS Platform. Parents are expected to view the 10 lessons over the course of a 12-week study period, complete worksheets, and to practice PRT at home.

Group II: Delayed Treatment Group (DTG) Active Control 1 Intervention

No intervention.

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]

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 pilot study involving seven teachers and students with autism spectrum disorder (ASD) found that training in classroom pivotal response teaching (CPRT) did not significantly improve teachers' implementation fidelity or students' communication skills and maladaptive behaviors.

Despite the lack of measurable improvements in student outcomes, teachers expressed high satisfaction with the CPRT training, suggesting that while the training may not have led to immediate changes, it could still be valuable for educators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Teachers to Implement Classroom Pivotal Response Teaching during Small-group Instruction: A Pilot Study. Verschuur, R., Huskens, B., Didden, R.[2021]

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]

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]

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]

A pilot study tested a developmental adaptation of Pivotal Response Treatment (PRT) with three infants at-risk for autism, showing promising results in enhancing their functional communication skills.

The introduction of PRT also improved parents' ability to implement the treatment effectively, suggesting that this approach could be a feasible intervention for very young children at-risk for autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pivotal response treatment for infants at-risk for autism spectrum disorders: a pilot study. Steiner, AM., Gengoux, GW., Klin, A., et al.[2021]

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. England pubmed.ncbi.nlm.nih.gov

Training Teachers to Implement Classroom Pivotal Response Teaching during Small-group Instruction: A Pilot Study. [2021]

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

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

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

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

6. England pubmed.ncbi.nlm.nih.gov

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

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

Pivotal response treatment for infants at-risk for autism spectrum disorders: a pilot study. [2021]