- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06182033
Penetrating the Classroom Social Network for Children With Language Impairment Via Peer Mediated Intervention (PEERS)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ohio
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Columbus, Ohio, United States, 43201
- Crane Center for Early Childhood Research and Policy
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
Business as usual
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Experimental: Peer-mediated pivotal response intervention
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Preschool Language Screener 5 (PLS-5) - Growth Scale Value
Time Frame: at baseline, 3 months, and 9 months
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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.
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at baseline, 3 months, and 9 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Developmental Pragmatic Profile (DPP)
Time Frame: at baseline and 9 months, month 9 reported
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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 = 26/Max = 104.
Higher scores on the DPP indicate greater language skills.
Raw score is calculated by summing scores across the 26 items comprising the DPP.
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at baseline and 9 months, month 9 reported
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Teacher-Child Rating Scale (TCRS)
Time Frame: at baseline, and 9 months, month 9 reported
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The Teacher-Child Rating Scale is a 32-item teacher-report instrument that measures children's social competence. Teachers respond to statements on a 5-point scale (1 = strongly disagree, 5 = strongly agree). To calculate each subscale score, one must sum positive items; sum negative items; subtract the sum of negative times from the number 24; sum this value with the sum of the positive items. Assertiveness Subscale: Range: (Min: 8/Max: 40 ) Behavior Control Subscale: (Min: 8/Max: 40) Peer Social Skills Subscale: (Min: 8/Max: 40) Talk Orientation Subscale: (Min: 8/Max: 40) Higher scores indicate higher skills as measured by each subscale. |
at baseline, and 9 months, month 9 reported
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Peer Incoming Talk
Time Frame: through study completion, an average of 9 months, month 9 reported
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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.
Investigators process these recordings to capture 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 (i) use 2D-proximity data from continuous location tracking to parse the audio 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.
Talk is operationalized as utterances per minute.
An utterance is a continuous piece of speech by an individual before or after which there is silence.
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through study completion, an average of 9 months, month 9 reported
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Peer Outgoing Talk
Time Frame: through study completion, an average of 9 months, month 9 reported
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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.
Investigators process these recordings to capture 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 (i) use 2D-proximity data from continuous location tracking to parse the audio into the cases where there is simultaneous peer proximity and recorded voice.
Incoming peer talk will be used to calculated out-degree centrality for each child on each of 8 randomly selected recording days to examine change in out-degree centrality over the course of an academic year.
Talk is operationalized as utterances per minute.
An utterance is a continuous piece of speech by an individual before or after which there is silence.
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through study completion, an average of 9 months, month 9 reported
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Peer Interactions
Time Frame: through study completion, an average of 9 months, final observation (up to 9 months) reported
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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 experienced by target children during the 30-minute observation.
Reliability will be assessed for 20% of observations via double-coding with observers blind to classroom and child condition.
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through study completion, an average of 9 months, final observation (up to 9 months) reported
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Play Interactions
Time Frame: through study completion, an average of 9 months; final observation (up to 9 months) reported
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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 experienced by target children during the 30-minute observation.
Reliability will be assessed for 20% of observations via double-coding with observers blind to classroom and child condition.
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through study completion, an average of 9 months; final observation (up to 9 months) reported
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laura M Justice, PhD, Ohio State University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R21DC018395 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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