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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 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.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2023-02-13 |
| Est. Completion | 2028-05-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05799599
The ClinicalTrials.gov registry entry for NCT05799599 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target. The listed sponsor is University of Kansas, which has 66 total studies on file at ClinicalTrials.gov.
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 2 study locations spanning 2 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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