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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06182033
Other study ID # R21DC018395
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2021
Est. completion date July 20, 2023

Study information

Verified date December 2023
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This exploratory experiment is designed to determine the extent to which the socialization experiences and social, behavioral, and linguistic skills of preschoolers with language impairment (LI) can be improved. The investigators implement a peer-mediated intervention in inclusive preschool classrooms, randomly assigned to treatment (n=12) or control (n=13) conditions. A focal child is identified in each classroom, representing a child with LI (3 to 5 years of age) who exhibits the poorest pragmatic-language skills and highest level of social exclusion in the classroom. Over a 12-week period, the focal children will receive peer-mediated intervention from identified peers, who use strategies to engage the focal child socially during center time, as supported by a classroom facilitator (teacher, aide). Outcomes of interest include the overarching classroom social network and its embedded socialization processes (e.g., frequency of child-to-child interaction), the focal child's interactions with peers and exposure to peer talk, and the focal child's social, behavioral, and linguistic skills. The study employs state-of-the-art social network analyses to represent the classroom network at the child, dyad, and network level and is dynamically modeled over the academic year using advanced location-tracking technologies and voice-activated recorders to capture incoming and outgoing peer talk for the focal child. The investigators anticipate the results of this study to yield significant theoretical and scientific impact. Theoretically, the investigators propose that improved socialization experiences in the preschool classroom can disrupt the social exclusion and peer maltreatment experienced by children with LI, leading to accelerated growth in linguistic, social, and behavioral outcomes for children with LI.


Description:

This study involves 25 inclusive preschool classrooms. The study uses an randomized controlled trial to estimate treatment impacts of a peer-mediated intervention, with 12 classrooms assigned to the treatment condition and 13 to the control condition. Within each classroom, the focal participants are children isolated from their classroom social network with low pragmatic language skills. One target child is selected per classroom using a priori exclusionary and inclusionary criteria. In the fall of each year, simple random assignment is used to allocate classrooms to the treatment group and to the control group. First, investigators identify all children's positions within the classroom social network using a teacher matrix conducted in fall of the academic year; from this network a child-level social network index is calculated (i.e., individual degree centrality; lower scores are characteristic of social exclusion). Second, teachers simultaneously complete the Developmental Pragmatic Profile (DPP) for each child in the classroom. Finally, among the participating focal children, investigators select the target child based on the lowest centrality scored weighted by DPP score, so that focal children represent the most socially isolated children with the poorest social-pragmatic communication skills. Children and teachers participate for a 9-month period, and the primary approach to treatment for focal children is described here. Specifically, focal children in classrooms randomized to the treatment condition receive peer-mediated pivotal response training (PRT) per procedures detailed by Brock et al.. PRT procedures are facilitated by a classroom facilitator-a classroom teacher or teaching assistant-who receives ongoing training and support from research staff. First, investigators provide a one-on-one 1-h training session for each facilitator that focuses on how to identify, initially train, and then support peers on a day-to-day basis during center time. Second, investigators partner with the facilitator to identify two peers who (a) demonstrate good social skills; (b) respond well to adult directions; (c) have consistent attendance; and (d) do not have a history of negative interactions with the target student. The facilitator explicitly identifies the focal child ("buddy") and asks the children to use three strategies to play with the buddy during center time: (a) offer buddy some play options; (b) show and talk about how to play with buddy; (c) compliment buddy. At each training session the facilitator describes one strategy, provides examples, and has peers practice the strategy through role play. During the role play the facilitator encourages and coaches peers to use the strategy as intended. The facilitator then provides ongoing support to peers during center time to implement the strategies by helping peers to set goals immediately before center time for use of the strategies, regularly encouraging peers and supporting peers to use the strategies, praising peers for use of the strategies, and reviewing peers' goals and interactions with the focal child at the end of center time. Facilitators provide this support during center time at least three times weekly for a 12-week period. The investigators propose that improved socialization experiences in the preschool classroom for focal children can disrupt the social exclusion, leading to accelerated growth in linguistic, social, and behavioral outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 197
Est. completion date July 20, 2023
Est. primary completion date May 30, 2023
Accepts healthy volunteers No
Gender All
Age group 36 Months to 66 Months
Eligibility General Inclusion Criteria - teacher informed consent - caregiver informed consent - 36 months of age or older. Exclusion Criteria: - no caregiver informed consent - younger than 36 months of age

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Peer-mediated pivotal response training
Teachers support children in the implementation of three strategies directed toward a target child identified as having language impairment and as isolated from the classroom social network.

Locations

Country Name City State
United States Crane Center for Early Childhood Research and Policy Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Foster TJ, Xiao N, Pelfrey GL, Gonzalez Villasanti H, Brock M, Justice LM. Peer-Mediated intervention for socially isolated preschoolers: An early-stage feasibility study. Language, Speech, and Hearing Services in Schools. 2023 (in press).

Outcome

Type Measure Description Time frame Safety issue
Primary Preschool Language Screener 5 (PLS-5) The PLS-5 is used to assess the auditory comprehension and expressive language skills of children from birth to age 7 years 11 months. For the present study, only the expressive language scale was administered, which is used to determine how well a child communicates with others. Specific skills assessed include naming, expressing quantity, describing, using specific prepositions, grammatical markers, sentence structures, and emergent literacy skills. An assessor indicates whether a child passes (1) or does not pass (0) each item.
Raw Score Range: Minimum = 0/Max = 67. The Standard Score is found using a conversion table provided in the PLS-5 Handbook. Higher scores on the PLS-5 indicate greater language skills.
at baseline, 3 months, and 9 months
Secondary Developmental Pragmatic Profile (DPP) A 26-item psychometrically sound checklist assessing children's pragmatic skills (e.g., conversational abilities, giving information), and DPP scores have strong classification accuracy in differentiating children with LI from non-affected classmates. This profile identifies non-verbal and verbal pragmatic deficits that may negatively influence social and academic communication in context. The questionnaire uses a 1 (never) to 4 (always) rating scale to assess the child's ability to appropriately communicate in social situations (i.e., "communicates [verbally and nonverbally] when playing with other children" or "introduces new conversation topics"). There is also a Not Appropriate option which indicates that the items is "Not appropriate for the child (culturally or other reason)." Raw Score Range: Minimum = 0/Max = 84. Higher scores on the DPP indicate greater language skills. at baseline, 3 months, and 9 months
Secondary Teacher-Child Rating Scale (TCRS) A 32-item teacher-report instrument that captures children's social, behavioral, and emotional competence. For the proposed study, investigators use the behavior control items to assess children's problem behaviors and the social competence items to capture three areas of interest: task orientation, assertiveness, and peer social skills. Teachers respond to statements on a 5-point scale (1 = strongly disagree, 5 = strongly agree) to describe each child in relation to these descriptions. This tool is easy and inexpensive to administer and yields psychometrically valid outputs on children's social and behavior issues that are applicable to children with disabilities in inclusive classrooms at baseline, 3 months, and 9 months
Secondary Peer Incoming Talk Researchers record the amount of incoming talk focal children experience using a hands-free voice-activated recorder worn by the child, with audio capture transcending the entire classroom day. With multiple hours of audio recorded per focal child, investigators process these recordings to capture duration of incoming talk with proximate peers using the following process: (i) augment the voice-recorder ability/voice detection/processing algorithms from the Matlab Audio Systems Toolbox to determine if people are speaking, and how long they are speaking; and (i) use 2D-proximity data from continuous location tracking to parse the audio tracks across time into the cases where there is simultaneous peer proximity and recorded voice. Incoming peer talk will be used to calculated in-degree centrality for each child on each of 8 randomly selected recording days to examine change in in-degree centrality over the course of an academic year. through study completion, an average of 9 months
Secondary Peer Outgoing Talk Researchers record the amount of outgoing talk vocalized by focal children using a hands-free voice-activated recorder worn by the child, with audio capture transcending the entire classroom day. With multiple hours of audio recorded per focal child, investigators process these recordings to capture duration of outgoing talk with proximate peers using the following process: (i) augment the voice-recorder ability/voice detection/processing algorithms from the Matlab Audio Systems Toolbox to determine if people are speaking, and how long they are speaking; and (i) use 2D-proximity data from continuous location tracking to parse the audio tracks across time into the cases where there is simultaneous peer proximity and recorded voice. Outgoing talk from the focal child to peers will be used to calculated out-degree centrality for each child on each of 8 randomly selected recording days to examine change in in-degree centrality over the course of an academic year. through study completion, an average of 9 months
Secondary Peer interactions Peer interactions of focal children were observed 4 times over the academic year using Brock's established protocol. Researchers observe the focal child for 30 minutes during center time and apply a partial interval recording system involving 15 s of observation and 45 s of documentation. For peer interactions, each interval is coded for whether the target child is interacting with peers. These observation data will be used to calculate frequency of peer interactions. Reliability will be assessed for 20% of observations via double-coding with observers blind to classroom and child condition. through study completion, an average of 9 months
Secondary Play interactions Play interactions of focal children will be observed 4 times over the academic year using Brock's established protocol. Observers will observe the focal child for 30 minutes during center time and apply a partial interval recording system involving 15 s of observation and 45 s of documentation. For play interactions, each interval is coded for whether the target child is engaged in play with peers. These observation data will be used to calculate frequency of play interactions. Reliability will be assessed for 20% of observations via double-coding with observers blind to classroom and child condition. through study completion, an average of 9 months
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