Peer Interventions for Autism

(PIPA Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Kansas

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

No Placebo Group

Trial Summary

What is the purpose of this trial?

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, using an innovative Sequential Multiple Assignment Randomized Trial (SMART) design. Available evidence supports the beneficial effects of PMIs for improving social communication in children with ASD. Peer-related social competence is vital to a wide range of child outcomes, such as improved communication and fewer behavioral problems. Unfortunately, approximately 30% of children with ASD remain minimally-verbal in kindergarten, restricting participation in inclusive activities. Recent studies report improved communication after a speech-generating device (SGD) is included in treatment. Effective interventions that can be modified is necessary to ensure optimal communication outcomes when children do not make anticipated progress. A strength of the study is that these interventions can be adopted by community-based, early service providers. All participants will receive an adapted Stay-Play-Talk (SPT) peer-mediated intervention that varies in active ingredients. With SMART designs, it is possible to test and identify alternative combinations of PMI approaches, such as the addition of a SGD. In this study, 132 preschoolers with ASD (and N=264 peers without disabilities) will be initially randomized to SPT and SGD with spoken peer input only (SPT Basic; peers taught to model language) or SPT and SGD with augmented peer input (SPT Plus; peers taught to use verbal language models concurrently with the SGD). Each child's response to treatment after 5 weeks will determine that child's next phase in the SMART design. Children showing a positive response will continue in their originally assigned group; slow responders will be randomly assigned to receive added treatment components to improve communication (either SPT Plus or SPT Advanced). SPT Advanced adds direct instruction strategies (i.e., adult prompts, reinforcers, and teaching trials) to increase child vocalizations in SGD interventions. The use of a SMART design extends our prior work by testing the systematic addition of selected peer-mediated strategies in combination with an SGD that allows for flexible application of interventions based on child response. The investigators have assembled an outstanding team of highly qualified investigators with complementary skills in preschool assessment, language intervention, clinical trials, and statistics.

Will I have to stop taking my current medications?

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

Is Peer-Mediated Intervention (PMI) safe for humans?

The research articles reviewed do not provide specific safety data for Peer-Mediated Intervention (PMI) in humans, focusing instead on its effectiveness in improving social skills for children with autism spectrum disorder. ^{1 2 3 4 5}

How is the Stay-Play-Talk treatment different from other autism treatments?

The Stay-Play-Talk treatment is unique because it uses typically developing peers to help children with autism improve their social skills and interactions, focusing on real-life settings like schools and communities. This peer-mediated approach is different from other treatments that may not involve peers as active participants in the therapy process. ^{1 2 3 4 5}

Research Team

Eligibility Criteria

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.

Currently using or a candidate for a speech-generating device

ASD diagnosis

Exclusion Criteria

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

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

I have no visual or hearing problems affecting my ability to follow instructions.

Trial Timeline

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)

Treatment Details

Interventions

• Stay-Play-Talk Advanced (Behavioral Intervention)
• Stay-Play-Talk Basic (Behavioral Intervention)
• Stay-Play-Talk Plus (Behavioral Intervention)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Kansas

Lead Sponsor

Trials

157

Recruited

332,000+

Lynne A. Bui

University of Kansas

Chief Medical Officer since 2017

MD from the David Geffen UCLA School of Medicine, BA in Molecular and Cell Biology from University of California, Berkeley

Randy Milby

University of Kansas

Chief Executive Officer since 2017

BS in Pharmacy from The University of Kansas, MBA in Finance/Marketing from Washington University in St. Louis – Olin Business School

Emory University

Collaborator

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

University of North Carolina

Collaborator

Trials

174

Recruited

1,457,000+

Michael O'Rand

University of North Carolina

Chief Executive Officer since 2022

PhD in Biology from Temple University

Dr. Miller

University of North Carolina

Chief Medical Officer since 2024

MD from Albert Einstein College of Medicine

Findings from Research

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]

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]

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]

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]

References

1. United States 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. [2020]

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

Broadening the Scope of Peer-Mediated Intervention for Individuals with Autism Spectrum Disorders. [2019]

3. China pubmed.ncbi.nlm.nih.gov

Effectiveness of peer-mediated intervention on social skills for children with autism spectrum disorder: a randomized controlled trial. [2022]

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

Peer mediation in play settings for minimally verbal students with autism Spectrum disorder. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

A systematic review of peer-mediated interventions for children with autism spectrum disorder. [2022]