NCT05799599 Peer Interventions for Preschoolers With Autism
| NCT ID | NCT05799599 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Kansas |
| Condition | Autism Spectrum Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 132 participants |
| Start Date | 2023-02-13 |
| Primary Completion | 2028-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 132 participants in total. It began in 2023-02-13 with a primary completion date of 2028-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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, 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.
Eligibility Criteria
Inclusion Criteria: * ASD diagnosis * limited or no spoken language defined by less than 20 functional, spontaneous words * currently using or a candidate for a speech-generating device * access to peers without disabilities * English as the primary language spoken at home Exclusion Criteria: * co-morbid or major medical conditions other than ASD, based on caregiver and teacher report * significant physical, sensory, or motor impairments that would prevent playing with another child * uncorrected visual or hearing impairments that would cause difficulty following peer instructions * a lack of symbol discrimination skills
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05799599 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, up to 6 Years, studying Autism Spectrum Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05799599 currently recruiting?
Yes, NCT05799599 is actively recruiting participants. Contact the research team at thiemann@ku.edu for enrollment information.
Where is the NCT05799599 trial being conducted?
This trial is being conducted at Kansas City, United States, Chapel Hill, United States.
Who is sponsoring the NCT05799599 clinical trial?
NCT05799599 is sponsored by University of Kansas. The trial plans to enroll 132 participants.