Recruiting

Peer Interventions

Sponsor:

University of Kansas

Code:

NCT05799599

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

Interventions

Stay-Play-Talk Basic

Stay-Play-Talk Plus

Stay-Play-Talk Advanced

Study Details

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.

Conditions

Autism Spectrum Disorder

Study ID

NCT05799599

Start date

Feb 13, 2023

Status verified date

Mar, 2024

Completion date

May 30, 2028

Anticipated

Primary completion date

May 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 6

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

132 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Stay-Play Talk Basic Followed by Stay Play Talk Basic - (SPT Basic Responders)

After being randomly assigned to the SPT Basic condition, these participants responded and therefore remained in this condition

active comparator: Stay Play Talk Basic Followed by Randomization to Stay Play Talk Basic (SPT Basic - SPT BASIC)

After being randomly assigned to the SPT Basic condition, these participants did not respond but were randomized to stay in this condition to examine longer duration in this treatment.

experimental: Stay Play Talk Basic Followed by Randomization to Stay Play Talk Plus (SPT Basic - SPT Plus)

After being randomly assigned to the SPT Basic condition, these participants did not respond and were randomized to Stay_Play_Talk Plus in the second stage.

experimental: Stay Play Talk Plus Followed by Stay Play Talk Plus (SPT Plus Responders)

After being randomly assigned to the SPT Plus condition, these participants responded and therefore remained in this condition

experimental: Stay Play Talk Plus Followed by Randomization to Stay Play Talk Plus (SPT Plus - SPT Plus)

After being randomly assigned to the SPT Plus condition, these participants did not respond and were randomized to Stay_Play_Talk Plus in the second stage.

experimental: Stay Play Talk Plus Followed by Randomization to Stay Play Talk Advanced (SPT Plus - SPT Advanced)

After being randomly assigned to the SPT Plus condition, these participants did not respond and were randomized to Stay_Play_Talk Advanced condition in the second stage which incorporates direct instruction.

Interventions

Stay-Play-Talk Basic

Stay-Play-Talk (SPT) Basic and SGD with augmented peer input in which peers are taught to model verbal responses while simultaneously selecting screen icons with spoken peer input only (i.e., peers taught to model language)

Stay-Play-Talk Plus

SPT Plus with augmented SGD peer input (i.e., peers taught to use verbal language models concurrently while selecting SGD icons).

Stay-Play-Talk Advanced

SPT Advanced adds direct instruction strategies for the children with ASD (i.e., adult prompts, reinforcers, and embedded teaching trials) to increase peer-directed communication.

Primary outcome measure

  • Change in rate of peer-directed communication acts [ Time Frame: Change in rate from baseline to 5 weeks, 12 weeks, and 16 weeks after start of treatment ]

Central Contacts and Locations

Central contacts

Katherine S Bourque, PhD

9138978445thiemann@ku.edu

Christine Muehe, Masters

913-897-8484cmuehe@ku.edu

Locations

Juniper Gardens Children's Project

Recruiting

Kansas City, Kansas, United States, 66101

Contacts

Katherine Bourque, PhD

913-897-8445thiemann@ku.edu

More Information

Sponsor

University of Kansas

Last update posted

Mar 28, 2024

Last verified

Mar, 2024

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Kansas on 2024-03-28.