RECRUITING

Peer Interventions for Preschoolers With Autism

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Examining Adaptive Peer-mediated Interventions for Preschoolers With Autism Spectrum Disorder and Limited or no Spoken Language: A Sequential Multiple Assignment Randomized Trial

Quick Facts

Study Start:2023-02-13
Study Completion:2028-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05799599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 6 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * ASD diagnosis
  2. * limited or no spoken language defined by less than 20 functional, spontaneous words
  3. * currently using or a candidate for a speech-generating device
  4. * access to peers without disabilities
  5. * English as the primary language spoken at home
  1. * co-morbid or major medical conditions other than ASD, based on caregiver and teacher report
  2. * significant physical, sensory, or motor impairments that would prevent playing with another child
  3. * uncorrected visual or hearing impairments that would cause difficulty following peer instructions
  4. * a lack of symbol discrimination skills

Contacts and Locations

Study Contact

Katherine S Bourque, PhD
CONTACT
9138978445
thiemann@ku.edu
Christine Muehe, Masters
CONTACT
913-897-8484
cmuehe@ku.edu

Study Locations (Sites)

Juniper Gardens Children's Project
Kansas City, Kansas, 66101
United States
University of North Carolina
Chapel Hill, North Carolina, 27599
United States

Collaborators and Investigators

Sponsor: University of Kansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-13
Study Completion Date2028-05-30

Study Record Updates

Study Start Date2023-02-13
Study Completion Date2028-05-30

Terms related to this study

Keywords Provided by Researchers

  • communication
  • intervention
  • speech-generating device
  • peer partners
  • preschool
  • social skills

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder