Peer Interventions for Preschoolers With Autism

Conditions

• Autism Spectrum Disorder

Eligibility Criteria

Sex

ALL

Age

3 Years - 6 Years

Healthy Volunteers

Not accepted

Interventions

• Stay-Play-Talk Basic — BEHAVIORAL
  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 — BEHAVIORAL
  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 — BEHAVIORAL
  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.

Study Details

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.

Key Dates

Start date

Feb 13, 2023

Status verified

Mar 2024

Primary completion

May 30, 2028

Completion

May 30, 2028

Study Design

Enrollment

132 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

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.

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

• Katherine S Bourque, PhD
  9138978445
  [email protected]
• Christine Muehe, Masters
  913-897-8484
  [email protected]

Locations (2)

Find similar trials in Kansas City, KS

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