Peer Interventions for Preschoolers With Autism (NCT05799599)
Examining Adaptive Peer-mediated Interventions for Preschoolers With Autism Spectrum Disorder and Limited or no Spoken Language: A Sequential Multiple Assignment Randomized Trial
๐ฉบ Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: Juniper Gardens Children's Project โ Kansas City, Kansas
Age range: 3 Years to 6 Years
๐งช Interventions in This Study
- Stay-Play-Talk Basic (BEHAVIORAL)
- Stay-Play-Talk Plus (BEHAVIORAL)
- Stay-Play-Talk Advanced (BEHAVIORAL)
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ All Participating Trial Locations (2 Sites)
- Juniper Gardens Children's Project โ Kansas City, Kansas
- University of North Carolina โ Chapel Hill, North Carolina
๐ Contact the Study Coordinator
Phone: (913) 897-8445
Email: thiemann@ku.edu
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
๐ฐ Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Autism Spectrum Disorder
- Improving the Part C Early Intervention Service Delivery System for Children With ASD โ Chicago, Illinois
- Treatment to Improve Sleep in Caregivers With Insomnia and a Child With Autism โ Philadelphia, Pennsylvania
- Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder โ New Haven, Connecticut
- PRISM Intervention Study โ Los Angeles, California
- ML-004 Open-Label Extension Study in Adults and Adolescents With Autism Spectrum Disorders (ASD) โ Dothan, Alabama
- MTT for Children With ASD Who Have Gastrointestinal Disorders โ Tempe, Arizona
Explore by condition: All Autism Spectrum Disorder clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.