NCT06182033

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 11, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 4, 2023

Completed
22 days until next milestone

First Posted

Study publicly available on registry

December 26, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

January 16, 2025

Completed
Last Updated

January 16, 2025

Status Verified

January 1, 2025

Enrollment Period

1.5 years

First QC Date

December 4, 2023

Results QC Date

May 28, 2024

Last Update Submit

January 15, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Preschool Language Screener 5 (PLS-5) - Growth Scale Value

    The PLS-5 is used to assess expressive language skills. 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. Growth Scale Value: Range: Minimum = 100/Max = 900. Higher scores indicate better expressive language skills. Assessed at baseline, 3 months, and 9 months. Baseline reported.

    at baseline, 3 months, and 9 months

Secondary Outcomes (6)

  • Developmental Pragmatic Profile (DPP)

    at baseline and 9 months, month 9 reported

  • Teacher-Child Rating Scale (TCRS)

    at baseline, and 9 months, month 9 reported

  • Peer Incoming Talk

    through study completion, an average of 9 months, month 9 reported

  • Peer Outgoing Talk

    through study completion, an average of 9 months, month 9 reported

  • Peer Interactions

    through study completion, an average of 9 months, final observation (up to 9 months) reported

  • +1 more secondary outcomes

Study Arms (2)

Peer-mediated pivotal response intervention

EXPERIMENTAL

Facilitators hold four 15-minute training sessions with the peer group to engage the target child. The facilitator explicitly identifies the "buddy" and asks the children to use four strategies to play with the child during center time: (a) offer your buddy some play options; (b) show and talk about how to play with your buddy; (c) compliment your buddy; and (d) show your buddy how to take turns. At each training session the facilitator will describe one strategy, provide examples, and practice the strategy through role play. After trainings, the facilitator provides ongoing support during center time to implement the strategies over 12 weeks during months 3-6 of the 9 months of study participation.

Behavioral: Peer-mediated pivotal response training

Control

NO INTERVENTION

Business as usual

Interventions

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.

Peer-mediated pivotal response intervention

Eligibility Criteria

Age36 Months - 66 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • teacher informed consent
  • caregiver informed consent
  • months of age or older.

You may not qualify if:

  • no caregiver informed consent
  • younger than 36 months of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Crane Center for Early Childhood Research and Policy

Columbus, Ohio, 43201, United States

Location

Related Publications (1)

  • Foster TJ, Xiao N, Pelfrey GL, Villasanti HG, Brock M, Justice L. Peer-Mediated Intervention for Socially Isolated Preschoolers: An Early-Stage Feasibility Study. Lang Speech Hear Serv Sch. 2024 Jan 11;55(1):166-180. doi: 10.1044/2023_LSHSS-23-00090. Epub 2023 Dec 4.

    PMID: 38048318BACKGROUND

Limitations and Caveats

The study protocol initially included the use of a waitlist control design. Given the study pause due to the impacts of the global pandemic and the landscape of early childhood education centers in the subsequent years during which study activities were implemented, our team instead opted to randomly assign participating classrooms to a study condition in lieu of the waitlist control design.

Results Point of Contact

Title
Dr. Laura Justice
Organization
Crane Center for Early Childhood Research and Policy at The Ohio State University

Study Officials

  • Laura M Justice, PhD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 26, 2023

Study Start

November 11, 2021

Primary Completion

May 30, 2023

Study Completion

July 20, 2023

Last Updated

January 16, 2025

Results First Posted

January 16, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations