NCT05799599Recruiting
Peer Interventions for Preschoolers With Autism
Examining Adaptive Peer-mediated Interventions for Preschoolers With Autism Spectrum Disorder and Limited or no Spoken Language: A Sequential Multiple Assignment Randomized Trial
Source: ClinicalTrials.gov · Last updated 28 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 132 (estimated)
- First submitted
- 23 Feb 2023
- Start date
- Feb 2023
- Primary completion date
- May 2028
- Lead sponsor
- University of Kansas
- Diseases
- Autism
- NCT number
- NCT05799599
What you commit to
- Study type: Interventional
- Planned participants: 132
- From Feb 2023 to the primary completion date, May 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- co-morbid or major medical conditions other than ASD, based on caregiver and teacher report
Other
- 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
Who the study is looking for
- 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
Age in the registry: 3 years to 6 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Not yet recruiting |
| Juniper Gardens Children's Project Coordinator of this site? Confirm its status | Kansas City | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.