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

40 Participants Needed

Trial Summary

What is the purpose of this trial?

There is an urgent need for improved access to effective autism treatments. With advances in technology, distance learning models have particular promise for families who cannot access evidence-based parent training locally or may be on long wait-lists for behavioral treatments. Pivotal Response Treatment (PRT) is an established treatment for autism spectrum disorder (ASD); however, a telehealth PRT model has not yet been evaluated in a controlled trial. This study will examine the effects of training parents in PRT via secure video conferencing and investigate 1) whether parents can learn via telehealth to deliver PRT in the home setting (PRT-T) and 2) whether their children will show greater improvement in functional communication skills compared to children in a waitlist control group. Participants will include 40 children age 2 to 5 years with ASD and significant language delay. Eligible children will be randomly assigned to either PRT-T (N=20) or waiting list (N=20). Weekly 60-minute parent training sessions will be delivered for 12 weeks via secure video conferencing software by a PRT-trained study therapist. The effects of PRT-T on parent fidelity of PRT implementation, child communication deficits including frequency of functional verbal utterances, and parent-report of communication skills on standardized questionnaires will be evaluated. This research will provide a foundation for wider dissemination of technology-based solutions to improve access to ASD treatment.

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 data supports the effectiveness of this treatment?

Research shows that Pivotal Response Treatment (PRT) is effective in improving communication and social skills in children with autism. Studies have found that parent training in PRT can enhance parent-child interactions and improve language skills, with parents generally satisfied with the program. ^{1 2 3 4 5}

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

Pivotal Response Treatment (PRT) is unique because it involves training parents to help improve their child's social communication skills, making it a natural and family-centered approach. It can be delivered via telehealth, which increases accessibility for families who might not have immediate access to in-person services. ^{1 2 3 4 5}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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]

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]

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]

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. England pubmed.ncbi.nlm.nih.gov

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

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

Brief parent training in pivotal response treatment for preschoolers with autism. [2019]

4. 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]

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

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