Peer InfluencePEERSNCT06182033
Penetrating the Classroom Social Network for Children With Language Impairment Via Peer Mediated Intervention
A study testing Peer-mediated pivotal response training in people with Peer Influence, run by Ohio State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 36 to 66 months
- Conditions the study is for
- Peer Influence
- What is being tested?
- Peer-mediated pivotal response training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2021to 20 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 66 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
None listed.
Who cannot join
- no caregiver informed consent
- younger than 36 months of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Crane Center for Early Childhood Research and Policy
Columbus, Ohio, 43201
About this study
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.
Read the 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.
- Conditions
- Peer Influence
- Being tested
- Peer-mediated pivotal response training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peer-mediated pivotal response trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Peer-mediated pivotal response training |
| Control | No intervention | Business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at baseline, 3 months, and 9 months
Secondary outcomes (6)
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 = 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.
Measured: at baseline and 9 months, month 9 reported
Teacher-Child Rating Scale (TCRS)
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.
Measured: at baseline, and 9 months, month 9 reported
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. 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.
Measured: through study completion, an average of 9 months, month 9 reported
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. 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.
Measured: through study completion, an average of 9 months, month 9 reported
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 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.
Measured: through study completion, an average of 9 months, final observation (up to 9 months) reported
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 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.
Measured: through study completion, an average of 9 months; final observation (up to 9 months) reported
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start11 Nov 2021
- Primary completion30 May 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peer InfluenceStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura M Justice, PhD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182033
- Sponsor's protocol ID
- R21DC018395
- Acronym
- PEERS
- Status last verified
- Jan 2025
- First submitted
- 4 Dec 2023
- Last updated
- 16 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38048318
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penetrating the Classroom Social Network for Children With Language Impairment Via Peer Mediated Intervention
- ClinicalTrials.gov ID
- NCT06182033
- Acronym / sponsor ID
- PEERS / R21DC018395
- Conditions
- Peer Influence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 30 May 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 26 Dec 2023 (actual)
- Results
- Posted 16 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peer-mediated pivotal response intervention | Experimental | Behavioral: Peer-mediated pivotal response trainingFacilitators 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. |
| Control | No intervention | –Business as usual |
Who may qualify
- Ages
- 36 to 66 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- no caregiver informed consent
- younger than 36 months of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peer-mediated pivotal response trainingTeachers 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. | Behavioural | Peer-mediated pivotal response intervention |
Primary outcome
Preschool Language Screener 5 (PLS-5) - Growth Scale Value
Time frame: at baseline, 3 months, and 9 months
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.
6 secondary outcomes
Developmental Pragmatic Profile (DPP)
Time frame: at baseline and 9 months, month 9 reported
Teacher-Child Rating Scale (TCRS)
Time frame: at baseline, and 9 months, month 9 reported
Peer Incoming Talk
Time frame: through study completion, an average of 9 months, month 9 reported
Peer Outgoing Talk
Time frame: through study completion, an average of 9 months, month 9 reported
Peer Interactions
Time frame: through study completion, an average of 9 months, final observation (up to 9 months) reported
Play Interactions
Time frame: through study completion, an average of 9 months; final observation (up to 9 months) reported
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 38048318Foster 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura M Justice, PhD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peer-mediated pivotal response training in people with Peer Influence, run by Ohio State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preschool Language Screener 5 (PLS-5) - Growth Scale Value (time frame: at baseline, 3 months, and 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06182033, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.