About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Sequential
Treatments tested in this trial
Stay-Play-Talk Basic
BehavioralStay-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
BehavioralSPT Plus with augmented SGD peer input (i.e., peers taught to use verbal language models concurrently while selecting SGD icons).
Stay-Play-Talk Advanced
BehavioralSPT Advanced adds direct instruction strategies for the children with ASD (i.e., adult prompts, reinforcers, and embedded teaching trials) to increase peer-directed communication.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Change in rate of peer-directed communication acts
Change in the rate per minute of peer-directed communication acts are defined as intentional communication acts that are clearly directed to a peer using eye contact/body orientation for a functional purpose (e.g., to request objects/actions, comment, or protest) and may include any communicative modality (i.e., vocalizations gestures, speech, and SGD). Trained coders will code communication acts for child-peer baseline and intervention videos using Noldus Observer XT measurement software.
Secondary outcomes
Rate of change in reciprocal child-peer exchanges
Rate of change in reciprocal social exchanges per 30-min of child-peer social interaction are defined as a one turn exchange between the child and peer and must include a minimum of one initiation and one response, independent of who starts the interaction.
Change in expressive vocabulary
Change in total number of different words (SGD and/or speech) coded using Noldus Observational Software
Change in expressive language
Change in total number of child's unique words (SGD and/or speech) coded using Noldus Observer Software
Change in expressive language multi-words
Change in total number of child's unique word combinations at each measurement point coded using Noldus Observational Software
Sponsors and contacts
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University of Kansas
Lead sponsor
University of North Carolina
Collaborator