Peer Interventions for Autism

(PIPA Trial)

Recruiting at 2 trial locations

Overseen By Christine Muehe, Masters

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Kansas

Disqualifiers: Major medical conditions, Physical impairments, Sensory impairments, others

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

Compensation: Varies

Number of Visits: 40

Duration: 5 weeks

132 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores peer-mediated interventions for young children with autism who have limited or no spoken language. It uses various combinations of peer interaction strategies and speech-generating devices to enhance communication and social skills. The researchers will adjust treatments based on each child's progress to identify the most effective approach. Children with autism who speak fewer than 20 words and are either using or could benefit from a speech-generating device are well-suited for this trial. As an unphased trial, it offers a unique opportunity for children to potentially improve their communication and social skills through innovative interventions.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that these peer-mediated interventions are safe for preschool children with ASD?

Research has shown that Stay-Play-Talk (SPT) activities are generally safe and well-received by children. These activities, where children assist each other, can enhance social interactions and improve communication skills in children with autism spectrum disorder (ASD).

For Stay-Play-Talk Plus, studies have found positive effects on social communication skills. Children typically respond well to these activities, with no major negative effects reported.

Similarly, Stay-Play-Talk Advanced, which includes direct teaching methods, has effectively improved interactions with peers. Research has not identified any significant safety issues.

Overall, these activities are designed to fit each child’s needs and are considered safe for helping children with ASD improve their communication skills. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stay-Play-Talk (SPT) interventions for autism because they focus on peer interactions to enhance social communication, which is a fresh approach compared to traditional therapies. Traditional treatments often rely on direct therapist-child interactions, while SPT encourages children with autism to practice social skills with their peers, potentially leading to more natural and lasting improvements. The SPT Plus and SPT Advanced variants introduce additional layers, like direct instruction and enhanced peer engagement strategies, making them particularly promising for children who might not respond to the basic approach. This peer-focused and adaptable method offers a new avenue for fostering social development in children with autism, which could significantly improve their ability to interact and communicate effectively in real-world settings.

What evidence suggests that this trial's treatments could be effective for improving social communication in children with ASD?

Research has shown that programs where children help each other, like Stay-Play-Talk (SPT), can greatly improve social communication skills in children with autism. In this trial, participants may be assigned to different versions of the SPT program. Studies have found that the basic version of SPT helps children with low social skills become more social. The SPT Plus version, which includes more peer interaction, has successfully increased interactions among children with autism. Stay-Play-Talk Advanced, which includes direct teaching, further improves communication by encouraging children to speak more. These programs hold promise for helping preschool children with autism become more communicative and socially active. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for preschoolers aged 3 to 6 with Autism Spectrum Disorder who have limited or no spoken language. They should be using or ready to use a speech-generating device and primarily speak English at home. Children must not have major medical conditions besides ASD, lack symbol discrimination skills, or have impairments that prevent play with peers.

Inclusion Criteria

I primarily speak English at home.

ASD diagnosis

Limited or no spoken language defined by less than 20 functional, spontaneous words

Exclusion Criteria

Co-morbid or major medical conditions other than ASD, based on caregiver and teacher report

A lack of symbol discrimination skills

I have physical or sensory issues that stop me from playing with others.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline observations and assessments are conducted, including peer recruitment and training, and initial setup of interventions

2-3 weeks

3 visits (in-person)

Treatment

Participants receive the Stay-Play-Talk (SPT) intervention with or without Speech-Generating Device (SGD) for 5 weeks, followed by re-randomization based on response

5 weeks

10 sessions (in-person)

Adaptive Treatment

Participants continue with their assigned intervention or receive additional treatment components based on response status for 12 weeks

12 weeks

24 sessions (in-person)

Follow-up

Participants are monitored for communication and behavioral outcomes post-treatment

4 weeks

3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Stay-Play-Talk Advanced
• Stay-Play-Talk Basic
• Stay-Play-Talk Plus

Trial Overview The study tests peer-mediated interventions (PMIs) like Stay-Play-Talk in various forms to improve social communication in children with autism. It uses a SMART design where kids start with basic PMI and may advance based on their response, potentially adding devices for communication or more direct teaching strategies.

How Is the Trial Designed?

Group I: Stay_Play_Talk Plus Followed by Stay_Play_Talk Plus (SPT Plus Responders) Experimental Treatment 1 Intervention

After being randomly assigned to the SPT Plus condition, these participants responded and therefore remained in this condition

Group II: Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Plus (SPT Plus - SPT Plus) Experimental Treatment 1 Intervention

After being randomly assigned to the SPT Plus condition, these participants did not respond and were randomized to Stay\_Play\_Talk Plus in the second stage.

Group III: Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Advanced (SPT Plus - SPT Advanced) Experimental Treatment 2 Interventions

After being randomly assigned to the SPT Plus condition, these participants did not respond and were randomized to Stay\_Play\_Talk Advanced condition in the second stage which incorporates direct instruction.

Group IV: Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Plus (SPT Basic - SPT Plus) Experimental Treatment 2 Interventions

After being randomly assigned to the SPT Basic condition, these participants did not respond and were randomized to Stay\_Play\_Talk Plus in the second stage.

Group V: Stay-Play_Talk Basic Followed by Stay_Play_Talk Basic - (SPT Basic Responders) Active Control 1 Intervention

After being randomly assigned to the SPT Basic condition, these participants responded and therefore remained in this condition

Group VI: Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Basic (SPT Basic - SPT BASIC) Active Control 1 Intervention

After being randomly assigned to the SPT Basic condition, these participants did not respond but were randomized to stay in this condition to examine longer duration in this treatment.

Stay-Play-Talk Advanced is already approved in United States, European Union for the following indications:

Approved in United States as Stay-Play-Talk Advanced for:

• Improving social communication in preschool children with Autism Spectrum Disorder (ASD)

Approved in European Union as Stay-Play-Talk Advanced for:

• Enhancing social interaction skills in children with ASD

Who Is Running the Clinical Trial?

University of Kansas

Lead Sponsor

Trials

157

Recruited

332,000+

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Published Research Related to This Trial

Peer-mediated intervention (PMI) is traditionally used in schools to help children with autism spectrum disorders (ASD) develop social skills through interactions with typically developing peers.

There is a need to expand PMI research to include friendship and social participation for adolescents and adults with ASD, focusing on community settings rather than just school environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Broadening the Scope of Peer-Mediated Intervention for Individuals with Autism Spectrum Disorders. Płatos, M., Wojaczek, K.[2019]

A randomized control trial involving 65 typically developing peers showed that peer-mediated interventions (PMIs) significantly improved the social play skills of these peers, indicating that they can benefit from participating in such interventions.

The outcomes for children with autism spectrum disorder (ASD) were not affected by the characteristics of their peers, suggesting that the intervention's effectiveness is consistent regardless of peer traits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can We Play Together? A Closer Look at the Peers of a Peer-Mediated Intervention to Improve Play in Children with Autism Spectrum Disorder. Kent, C., Cordier, R., Joosten, A., et al.[2020]

A play-based peer-mediated intervention (PMI) was effective in improving socio-communicative skills such as play, social engagement, and motor imitation in minimally verbal students with autism spectrum disorder (ASD) and intellectual disability, with seven children participating in the study.

The intervention showed positive outcomes for most participants, with some children demonstrating significant improvements in play duration and interactive play, highlighting the potential of PMIs for inclusive education, though individual differences suggest the need for further research to understand varying responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer mediation in play settings for minimally verbal students with autism Spectrum disorder. Briet, G., Le Maner-Idrissi, G., Seveno, T., et al.[2023]

Peer mediated interventions (PMIs) effectively improve social skills in children with autism spectrum disorder (ASD), as shown in a systematic review of five studies, including four randomized controlled trials.

The interventions were primarily conducted in school settings and resulted in significant improvements in social initiations, responses, and communication, indicating that PMIs can be successfully implemented in real-world contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of peer-mediated interventions for children with autism spectrum disorder. Chang, YC., Locke, J.[2022]

Peer-mediated intervention (PMI) significantly improved social skills in children with mild to moderate autism spectrum disorder (ASD) compared to traditional behavioral therapy, as shown by a notable decrease in Social Responsiveness Scale (SRS) scores in the experimental group (n=29) after the intervention.

The study, which included 55 children aged 4-12 years, found that PMI not only enhanced social communication but also increased social motivation and reduced undesirable behavior patterns, indicating its effectiveness in fostering social interactions among children with varying levels of ASD symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of peer-mediated intervention on social skills for children with autism spectrum disorder: a randomized controlled trial. Zhang, B., Liang, S., Chen, J., et al.[2022]

Citations

1. journals.sagepub.com journals.sagepub.com/doi/10.1177/1098300720983521

Systematic Review and Meta-Analysis of Stay-Play-Talk ... Although results of the current review suggest SPT may be an effective intervention for improving social behaviors of children with low social ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05799599

Peer Interventions for Preschoolers With Autism This proposal will evaluate a series of peer-mediated interventions (PMIs) for preschool children (3 to 6 years) with ASD and limited or no spoken language, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5087797/

A systematic review of peer-mediated interventions for ... Peer mediated intervention (PMI) is a promising practice used to increase social skills in children with autism spectrum disorder (ASD).

4. researchgate.net researchgate.net/publication/283895248_Peers_as_Clinicians_Examining_the_Impact_of_Stay_Play_Talk_on_Social_Communication_in_Young_Preschoolers_with_Autism

Peers as Clinicians: Examining the Impact of Stay Play Talk ... Across several studies, Stay-Play-Talk has been demonstrated to be effective to increase social interaction of children with Autism Spectrum ...

5. uknowledge.uky.edu uknowledge.uky.edu/cgi/viewcontent.cgi?article=1178&context=edsrc_etds

the effects of a stay-play-talk intervention on social ... The purpose of this study was to examine the effectiveness of the Stay-Play-Talk. (SPT) intervention for increasing the rate of peer ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26606507/

Peers as clinicians: Examining the impact of Stay Play Talk ... This paper will explain the impacts of the Stay Play Talk intervention on the social communication skills of young children with ASD.

7. files.eric.ed.gov files.eric.ed.gov/fulltext/EJ1359204.pdf

Systematic Review and Meta-Analysis of Stay-Play-Talk ... Despite mostly positive outcomes, authors noted that it was difficult to identify for whom and under what conditions PMIs were optimally effective (e.g., ...

8. advancedautism.com advancedautism.com/post/the-role-of-scripting-in-autism-therapy-and-how-to-reduce-its-dependency

The Role of Scripting in Autism Therapy and How to ... Scripting is a common behavior among individuals with autism spectrum disorder (ASD) that involves repeating words, phrases, or dialogues learned from media, ...

9. researchgate.net researchgate.net/publication/353957538_A_Systematic_Review_of_Play-Based_Interventions_Targeting_the_Social_Communication_Skills_of_Children_with_Autism_Spectrum_Disorder_in_Educational_Contexts

(PDF) A Systematic Review of Play-Based Interventions ... Children with autism spectrum disorder (ASD) experience social communication difficulties which can be compounded by increased social ...