Peer Interventions for Preschoolers With Autism
PIPA
Examining Adaptive Peer-mediated Interventions for Preschoolers With Autism Spectrum Disorder and Limited or no Spoken Language: A Sequential Multiple Assignment Randomized Trial
1 other identifier
interventional
132
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 13, 2023
CompletedFirst Submitted
Initial submission to the registry
February 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 30, 2028
March 28, 2024
March 1, 2024
5.3 years
February 23, 2023
March 26, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Change in rate from baseline to 5 weeks, 12 weeks, and 16 weeks after start of treatment
Secondary Outcomes (7)
Rate of change in reciprocal child-peer exchanges
Change in rate of reciprocity from baseline to 5 weeks, at 12 weeks, and at 16 weeks
Change in expressive vocabulary
secondary at baseline, 5 weeks, 12 weeks, and 16 weeks
Change in expressive language
secondary at baseline, 5 weeks, 12 weeks, and 16 weeks
Change in expressive language multi-words
secondary at baseline, 5 weeks, 12 weeks, and 16 weeks
Parent Target Problem Narratives for ASD symptoms
Baseline and 12 weeks
- +2 more secondary outcomes
Study Arms (6)
Stay-Play_Talk Basic Followed by Stay_Play_Talk Basic - (SPT Basic Responders)
ACTIVE COMPARATORAfter being randomly assigned to the SPT Basic condition, these participants responded and therefore remained in this condition
Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Basic (SPT Basic - SPT BASIC)
ACTIVE COMPARATORAfter 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.
Stay_Play_Talk Basic Followed by Randomization to Stay_Play_Talk Plus (SPT Basic - SPT Plus)
EXPERIMENTALAfter 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.
Stay_Play_Talk Plus Followed by Stay_Play_Talk Plus (SPT Plus Responders)
EXPERIMENTALAfter being randomly assigned to the SPT Plus condition, these participants responded and therefore remained in this condition
Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Plus (SPT Plus - SPT Plus)
EXPERIMENTALAfter 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.
Stay_Play_Talk Plus Followed by Randomization to Stay_Play_Talk Advanced (SPT Plus - SPT Advanced)
EXPERIMENTALAfter 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 (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)
SPT Plus with augmented SGD peer input (i.e., peers taught to use verbal language models concurrently while selecting SGD icons).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Kansaslead
- University of North Carolinacollaborator
Study Sites (2)
Juniper Gardens Children's Project
Kansas City, Kansas, 66101, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Masking Details
- In addition, we will have a blind coder who will code child-peer communication as an outcome measure.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 23, 2023
First Posted
April 5, 2023
Study Start
February 13, 2023
Primary Completion (Estimated)
May 30, 2028
Study Completion (Estimated)
May 30, 2028
Last Updated
March 28, 2024
Record last verified: 2024-03