Trial Outcomes & Findings for Penetrating the Classroom Social Network for Children With Language Impairment Via Peer Mediated Intervention (NCT NCT06182033)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

30 participants

Primary outcome timeframe

at baseline, 3 months, and 9 months

Results posted on

2025-01-16

Participant Flow

Classrooms were randomly assigned to condition. One target child was selected within each classroom prior to random assignment. As such, the number of classrooms in the study and the number of target children analyzed and reported are equivalent. Target children in classrooms assigned to the treatment condition experienced peer-mediated pivotal response training. Target children in control classrooms experiences business as usual.

Unit of analysis: classrooms

Participant milestones

Participant milestones
Measure	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. 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.	Control Business as usual
Overall Study STARTED	15 15	15 15
Overall Study Baseline Assessments	14 14	14 14
Overall Study Timepoint 2 Assessment	12 12	13 13
Overall Study COMPLETED	12 12	13 13
Overall Study NOT COMPLETED	3 3	2 2

Reasons for withdrawal

Reasons for withdrawal
Measure	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. 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.	Control Business as usual
Overall Study No baseline survey provided. Needed for target child selection.	1	1
Overall Study Target child relocation	1	1
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Penetrating the Classroom Social Network for Children With Language Impairment Via Peer Mediated Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peer Mediated Pivotal Response Intervention n=12 Participants 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. 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	Control n=13 Participants Business as usual	Total n=25 Participants Total of all reporting groups
Age, Continuous	50.42 months STANDARD_DEVIATION 8.37 • n=5 Participants	51.77 months STANDARD_DEVIATION 11.04 • n=7 Participants	51.12 months STANDARD_DEVIATION 9.67 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Black non-hispanic	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · White non-Hispanic	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Hispanic	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Multiracial-non-Hispanic	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race and Ethnicity · Not Reported	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Region of Enrollment United States	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Preschool Language Screener 5 GROWTH SCALE VALUE	437.09 Score on a scale STANDARD_DEVIATION 38.55 • n=5 Participants	455.38 Score on a scale STANDARD_DEVIATION 53.40 • n=7 Participants	447 Score on a scale STANDARD_DEVIATION 47.12 • n=5 Participants

PRIMARY outcome

Timeframe: at baseline, 3 months, and 9 months

Population: At baseline and 3 months, 11 participants were assessed with the PLS-5 in the peer-mediated pivotal response intervention group instead of the total number in the sample (n = 12) because one participant was consistently absent from school during the assessment window. At 9 months, 12 participants were assessed with the PLS-5 in the control group instead of the total number in the sample (n = 13) because one participant was consistently absent from school during the assessment window.

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.

Outcome measures

Outcome measures
Measure	Peer-mediated Pivotal Response Intervention n=12 Participants 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. 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.	Control n=13 Participants Business as usual
Preschool Language Screener 5 (PLS-5) - Growth Scale Value 9 months	459.08 score on a scale Standard Deviation 36.59	478.58 score on a scale Standard Deviation 42.37
Preschool Language Screener 5 (PLS-5) - Growth Scale Value Baseline	437.09 score on a scale Standard Deviation 38.55	455.38 score on a scale Standard Deviation 53.40
Preschool Language Screener 5 (PLS-5) - Growth Scale Value 3 months	459.09 score on a scale Standard Deviation 40.59	464.77 score on a scale Standard Deviation 52.32

SECONDARY outcome

Timeframe: at baseline and 9 months, month 9 reported

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.

Outcome measures

Outcome measures
Measure	Peer-mediated Pivotal Response Intervention n=12 Participants 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. 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.	Control n=13 Participants Business as usual
Developmental Pragmatic Profile (DPP)	68.75 score on a scale Standard Deviation 18.54	77.42 score on a scale Standard Deviation 12.46

SECONDARY outcome

Timeframe: at baseline, and 9 months, month 9 reported

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.

Outcome measures

Outcome measures
Measure	Peer-mediated Pivotal Response Intervention n=12 Participants 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. 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.	Control n=13 Participants Business as usual
Teacher-Child Rating Scale (TCRS) Task Orientation	25 score on a scale Standard Deviation 6.09	26.5 score on a scale Standard Deviation 9.15
Teacher-Child Rating Scale (TCRS) Assertiveness	25.50 score on a scale Standard Deviation 5.89	28.42 score on a scale Standard Deviation 7.04
Teacher-Child Rating Scale (TCRS) Behavior Control	25.42 score on a scale Standard Deviation 7.85	26.67 score on a scale Standard Deviation 7.45
Teacher-Child Rating Scale (TCRS) Peer Social Skills	26 score on a scale Standard Deviation 10.22	27.25 score on a scale Standard Deviation 7.84

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Peer-mediated Pivotal Response Intervention n=12 Participants 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. 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.	Control n=13 Participants Business as usual
Peer Incoming Talk	5.86 utterances per minute--final observation Standard Deviation 5.41	6.35 utterances per minute--final observation Standard Deviation 4.35

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Peer-mediated Pivotal Response Intervention n=12 Participants 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. 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.	Control n=13 Participants Business as usual
Peer Outgoing Talk	4.68 outgoing utterances per minute-final obs Standard Deviation 11.34	5.22 outgoing utterances per minute-final obs Standard Deviation 3.73

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Peer-mediated Pivotal Response Intervention n=12 Participants 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. 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.	Control n=13 Participants Business as usual
Peer Interactions Incoming Peer Interactions	43 percentage of intervals Standard Deviation 15.9	21.7 percentage of intervals Standard Deviation 19.6
Peer Interactions Outgoing Peer Interactions	42.3 percentage of intervals Standard Deviation 18.4	22 percentage of intervals Standard Deviation 17.4

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Peer-mediated Pivotal Response Intervention n=12 Participants 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. 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.	Control n=13 Participants Business as usual
Play Interactions	43 percentage of intervals Standard Deviation 25.9	24.7 percentage of intervals Standard Deviation 23.1

Adverse Events

Peer-mediated Pivotal Response Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Laura Justice

Crane Center for Early Childhood Research and Policy at The Ohio State University

Phone: 614-247-7488

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place