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NCT05799599 · ClinicalTrials.gov registry record · NA

Peer Interventions for Preschoolers With Autism

A NA study of Autism Spectrum Disorder, sponsored by University of Kansas.

Recruiting
Registry status
NA
Development phase
132
Enrollment target
2
Study locations

NCT05799599: Recruiting NA study of Autism Spectrum Disorder, sponsored by University of Kansas.

NCT05799599 is a NA study of Autism Spectrum Disorder that is actively recruiting participants, run by University of Kansas. The registered enrollment target is 132 participants, roughly in line with the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target. The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT05799599, a NA study of Autism Spectrum Disorder, is actively recruiting participants, sponsored by University of Kansas.

RECRUITING
Registry status
NA
Development phase
132 participants
Enrollment target
2
Study locations

Study Summary

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

Primary Outcome

Change in the rate per minute of peer-directed communication acts are defined as intentional communication acts that are clearly directed to a peer using eye contact/body orientation for a functional purpose (e.g., to request objects/actions, comment, or protest) and may include any communicative modality (i.e., vocalizations gestures, speech, and SGD). Trained coders will code communication acts for child-peer baseline and intervention videos using Noldus Observer XT measurement software.

Conditions Studied

Interventions

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

Study Locations (2)

Kansas

  • Juniper Gardens Children's Project - Kansas City

North Carolina

  • University of North Carolina - Chapel Hill

Trial Details

FieldValue
Enrollment Target 132 participants
Start Date 2023-02-13
Est. Completion 2028-05-30
Phase NA
University of Kansas

66 total trials

What NCT05799599 shows while recruiting

NCT05799599 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target.

The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 3 interventions - of which Stay-Play-Talk Basic is the first listed.

NCT05799599 reports a single indexed study location in Kansas, North Carolina.

Frequently Asked Questions

What is clinical trial NCT05799599 about?

NCT05799599 is a clinical study titled "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, using an innovative Sequential Multiple Assignment Randomized Trial (SMART) design. Available evidence supports the beneficial effects of PMIs ...

What is the current status of trial NCT05799599?

This trial is currently recruiting. It is a NA study. The enrollment target is 132 participants. The study started on 2023-02-13. Estimated completion is 2028-05-30.

What conditions does trial NCT05799599 study?

This clinical trial studies the following conditions: Autism Spectrum Disorder.

What interventions are being tested in trial NCT05799599?

The interventions under investigation include: Stay-Play-Talk Basic (BEHAVIORAL), Stay-Play-Talk Plus (BEHAVIORAL), Stay-Play-Talk Advanced (BEHAVIORAL).

Who is sponsoring clinical trial NCT05799599?

This trial is sponsored by University of Kansas, which has 66 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05799599 being conducted?

This trial has 2 study locations across Kansas, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Autism Spectrum Disorder

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT05799599's enrollment target sits among peer trials

132 64th of 224 higher than 160 of 224 other Autism Spectrum Disorder trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05799599, the US trial registry maintained by the National Library of Medicine. NCT05799599 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.