Telehealth Parent Training for PRT for Autism

Overseen By Jane Shkel

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Stanford University

Disqualifiers: Non-English, Severe psychiatric, Severe seizures, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 12

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve access to autism treatment by training parents via telehealth to use Pivotal Response Treatment (PRT), a well-known method for helping children with autism. Researchers seek to determine if parents can effectively learn PRT at home through online sessions and if their children’s communication skills improve as a result. The trial seeks children aged 2 to 5 with autism and noticeable language delays, whose parents can participate in online training. Participants will either receive the telehealth training or remain on a waitlist while continuing their usual care. This study could make autism treatment more accessible to families facing long wait times or lacking local resources. As an unphased trial, it offers families a chance to contribute to making autism treatment more accessible and effective.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether participants must stop taking their current medications. However, it requires that any treatment be stable for at least 2 weeks before starting the trial, with no anticipated changes during participation.

What prior data suggests that this telehealth parent training for PRT is safe for children with autism?

Research has shown that Pivotal Response Treatment (PRT) is a well-known method for helping children with autism. PRT aims to improve social communication skills and is based on principles from applied behavior analysis, a common approach in autism therapy.

Although specific studies on the telehealth version of PRT are lacking, many studies have examined the traditional form. These studies found that PRT can significantly help children with autism improve their language and communication skills.

No direct evidence indicates safety concerns or negative effects from PRT itself, suggesting that the treatment is generally well-tolerated. Since this trial uses a telehealth model, which simply delivers the same proven treatment differently, similar safety results are expected.

Overall, PRT has a strong track record as a safe and effective way to improve communication in children with autism. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using telehealth to deliver Pivotal Response Treatment (PRT) for autism because it makes parent training more accessible and flexible. Unlike traditional in-person therapy sessions, this method allows parents to learn and implement PRT strategies in their own homes through secure video calls, making it easier for families who might struggle with transportation or scheduling conflicts. This approach empowers parents to be active participants in their child's therapy, potentially leading to more consistent intervention and better outcomes for children with autism.

What evidence suggests that telehealth parent training for PRT is effective for autism?

Studies have shown that Pivotal Response Treatment (PRT) improves social communication skills in children with autism. Research has found that children in various studies have made significant progress in language and communication. In this trial, some participants will receive PRT Telehealth, where participating parents will undergo 12 weekly 60-minute parent training sessions via secure videoconference to learn PRT. A small study on delivering PRT through telehealth suggested that it is both practical and helpful for parents to learn and use the treatment at home. This online version of PRT has shown promising results, making it a good option for families who cannot access traditional in-person services. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children aged 2 to 5 with Autism Spectrum Disorder (ASD) and significant language delays. They must have been diagnosed or suspected of ASD, speak English as a primary language, and have stable treatments with no major changes expected during the study. Children who receive extensive ABA therapy, live close to Stanford University, or have severe behavioral issues are not eligible.

Inclusion Criteria

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

I am an English-speaking parent who can participate in all study procedures.

I've been on a stable treatment plan for over 2 weeks with limited speech therapy.

Exclusion Criteria

My child's first language is not English.

You or a family member have a serious mental illness or an unstable medical condition.

You have already tried a treatment that is considered to be effective for your condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participating parents receive 12 weekly 60-minute parent training sessions via secure videoconference to learn Pivotal Response Treatment

12 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Pivotal Response Treatment

Trial Overview The trial tests if parents can learn Pivotal Response Treatment (PRT) through video calls to help their kids improve communication skills. It compares kids getting PRT via telehealth against those on a waitlist. The study involves weekly sessions over three months and measures how well parents apply PRT and any progress in the child's verbal abilities.

How Is the Trial Designed?

Group I: PRT Telehealth Experimental Treatment 1 Intervention

Participating parents will receive 12 weekly 60-minute parent training sessions via secure videoconference to learn Pivotal Response Treatment

Group II: Waitlist Active Control 1 Intervention

Participants will continue stable community-based treatments

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)

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+

Published Research Related to This Trial

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]

Brief training in Pivotal Response Treatment (PRT) for parents of preschoolers with autism led to significant improvements in children's communication skills, as evidenced by increased functional utterances after the training.

The study, involving eight preschoolers and their parents, demonstrated that parents' ability to effectively implement PRT techniques improved, and this was linked to the children's enhanced communication, suggesting that this training could serve as a timely and cost-effective intervention while waiting for more comprehensive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief parent training in pivotal response treatment for preschoolers with autism. Coolican, J., Smith, IM., Bryson, SE.[2019]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5488784/

Pivotal response treatment for autism spectrum disorder Pivotal response treatment (PRT) is a behavioral intervention aimed to improve social communication skills in individuals with ASD,,,, which has accumulated a ...

2. pediatrics.jmir.org pediatrics.jmir.org/2022/3/e32520/

Feasibility and Acceptability of Delivering Pivotal Response ... The aim of this study was to assess the feasibility, acceptability, and clinical effects of an online model of PRT delivered via MindNest Health.

3. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.766150/full

Examining Effectiveness and Predictors of Treatment ... Statistically significant effects of PRT were identified across a majority of identified RCTs for a range of language and communication skills.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02721381

Comparative Efficacy of Self-directed & Therapist-assisted ... Aim 1: To examine the comparative efficacy of self-directed and therapist-assisted ImPACT Online on parent outcomes at post-treatment and the 3-month follow-up.

5. tandfonline.com tandfonline.com/doi/full/10.1080/15021149.2024.2416270?src=exp-la

Telehealth pivotal response treatment parent training The purpose of this pilot study was to assess the feasibility, benefits, and acceptability of a telehealth Pivotal Response Treatment (PRT) parent training ...

6. ies.ed.gov ies.ed.gov/ncee/wwc/EvidenceSnapshot/668

WWC | Pivotal Response Training PRT was found to have no discernible effects on communication/language competencies for children and students with an autism spectrum disorder. Pivotal response ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT01908686

Pivotal Response Treatment for Children With Autism ... The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with Autism Spectrum Disorder (ASD) (Pivotal ...

8. medicine.yale.edu medicine.yale.edu/trial/pivotal-response-treatment-for-children-with-autism-spectrum-disorders/

Pivotal Response Treatment for Children With Autism ... The purpose of this study is to evaluate the application of an evidence-based, manualized treatment for children with ASD (Pivotal Response ...