Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2025-12-27 @ 1:39 PM
Study NCT ID:
NCT06182033
Status:
COMPLETED
Last Update Posted:
2025-01-16
First Post:
2023-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Penetrating the Classroom Social Network for Children With Language Impairment Via Peer Mediated Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'justice.57@osu.edu', 'phone': '614-247-7488', 'title': 'Dr. Laura Justice', 'organization': 'Crane Center for Early Childhood Research and Policy at The Ohio State University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '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.'}}, 'adverseEventsModule': {'timeFrame': 'No formal monitoring occurred. Researchers interacted with participants over the 9-month period of their study involvement.', 'description': 'All cause mortality and serious adverse events were not formally monitored. No drugs or medical procedures were administered to subjects as part of this study. The research activities reported herein were deemed as minimal risk by the Institutional Review Board responsible for the oversight of this study. No adverse events occurred throughout the duration of the project. Study activities were monitored by checking in with research partners when visiting schools for data collection.', 'eventGroups': [{'id': 'EG000', 'title': 'Peer-mediated Pivotal Response Training', 'description': '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.', 'otherNumAtRisk': 12, 'deathsNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control', 'description': 'Business as usual', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Preschool Language Screener 5 (PLS-5) - Growth Scale Value', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-mediated Pivotal Response Intervention', 'description': '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.\n\nPeer-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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Business as usual'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '437.09', 'spread': '38.55', 'groupId': 'OG000'}, {'value': '455.38', 'spread': '53.40', 'groupId': 'OG001'}]}]}, {'title': '3 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '459.09', 'spread': '40.59', 'groupId': 'OG000'}, {'value': '464.77', 'spread': '52.32', 'groupId': 'OG001'}]}]}, {'title': '9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '459.08', 'spread': '36.59', 'groupId': 'OG000'}, {'value': '478.58', 'spread': '42.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.84', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood'}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, 3 months, and 9 months', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '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.'}, {'type': 'SECONDARY', 'title': 'Developmental Pragmatic Profile (DPP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-mediated Pivotal Response Intervention', 'description': '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.\n\nPeer-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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Business as usual'}], 'classes': [{'categories': [{'measurements': [{'value': '68.75', 'spread': '18.54', 'groupId': 'OG000'}, {'value': '77.42', 'spread': '12.46', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.727', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We conducted a linear regression. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood'}], 'paramType': 'MEAN', 'timeFrame': 'at baseline and 9 months, month 9 reported', 'description': '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Teacher-Child Rating Scale (TCRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-mediated Pivotal Response Intervention', 'description': '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.\n\nPeer-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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Business as usual'}], 'classes': [{'title': 'Assertiveness', 'categories': [{'measurements': [{'value': '25.50', 'spread': '5.89', 'groupId': 'OG000'}, {'value': '28.42', 'spread': '7.04', 'groupId': 'OG001'}]}]}, {'title': 'Behavior Control', 'categories': [{'measurements': [{'value': '25.42', 'spread': '7.85', 'groupId': 'OG000'}, {'value': '26.67', 'spread': '7.45', 'groupId': 'OG001'}]}]}, {'title': 'Peer Social Skills', 'categories': [{'measurements': [{'value': '26', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '27.25', 'spread': '7.84', 'groupId': 'OG001'}]}]}, {'title': 'Task Orientation', 'categories': [{'measurements': [{'value': '25', 'spread': '6.09', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '9.15', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.205', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "These analyses use the assertiveness subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood'}, {'pValue': '.034', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "This analysis focused specifically on the behavior control subscale. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood'}, {'pValue': '.099', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "These analyses use the Task Orientation subscale as the outcome variable. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood'}, {'pValue': '.209', 'groupIds': ['OG000', 'OG001'], 'groupDescription': "This analysis used peer social skills subscale as the outcome in the model. We conducted a linear regression for each of the measure's subscales. We accounted for baseline, which allowed us to examine residualized gains. We controlled for age.", 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'at baseline, and 9 months, month 9 reported', 'description': "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.\n\nAssertiveness 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)\n\nHigher scores indicate higher skills as measured by each subscale.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peer Incoming Talk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-mediated Pivotal Response Intervention', 'description': '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.\n\nPeer-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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Business as usual'}], 'classes': [{'categories': [{'measurements': [{'value': '5.86', 'spread': '5.41', 'groupId': 'OG000'}, {'value': '6.35', 'spread': '4.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.82', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.', 'statisticalMethod': 'Multilevel Model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood'}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 9 months, month 9 reported', 'description': '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.', 'unitOfMeasure': 'utterances per minute--final observation', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peer Outgoing Talk', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-mediated Pivotal Response Intervention', 'description': '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.\n\nPeer-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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Business as usual'}], 'classes': [{'categories': [{'measurements': [{'value': '4.68', 'spread': '11.34', 'groupId': 'OG000'}, {'value': '5.22', 'spread': '3.73', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.67', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.', 'statisticalMethod': 'Multilevel Model', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Rogers and Restricted Maximum Likelihood adjustments in light of small sample size to reduce error likelihood.'}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 9 months, month 9 reported', 'description': '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.', 'unitOfMeasure': 'outgoing utterances per minute-final obs', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Peer Interactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-mediated Pivotal Response Intervention', 'description': '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.\n\nPeer-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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Business as usual'}], 'classes': [{'title': 'Incoming Peer Interactions', 'categories': [{'measurements': [{'value': '43', 'spread': '15.9', 'groupId': 'OG000'}, {'value': '21.7', 'spread': '19.6', 'groupId': 'OG001'}]}]}, {'title': 'Outgoing Peer Interactions', 'categories': [{'measurements': [{'value': '42.3', 'spread': '18.4', 'groupId': 'OG000'}, {'value': '22', 'spread': '17.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.024', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Rogers and Restricted Maximum Likelihood to account for the small sample size.'}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 9 months, final observation (up to 9 months) reported', 'description': "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.", 'unitOfMeasure': 'percentage of intervals', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Play Interactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Peer-mediated Pivotal Response Intervention', 'description': '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.\n\nPeer-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.'}, {'id': 'OG001', 'title': 'Control', 'description': 'Business as usual'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '24.7', 'spread': '23.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.013', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'We examined the trajectory across timepoints using a multilevel model that controlled for age. The p value is in reference to the difference between the treatment and control children at the final observation.', 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward Rogers and Restricted Maximum Likelihood adjustment made to reduce error likelihood'}], 'paramType': 'MEAN', 'timeFrame': 'through study completion, an average of 9 months; final observation (up to 9 months) reported', 'description': "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.", 'unitOfMeasure': 'percentage of intervals', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Peer-mediated Pivotal Response Intervention', 'description': '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.\n\nPeer-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.'}, {'id': 'FG001', 'title': 'Control', 'description': 'Business as usual'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numUnits': '15', 'numSubjects': '15'}, {'groupId': 'FG001', 'numUnits': '15', 'numSubjects': '15'}]}, {'type': 'Baseline Assessments', 'achievements': [{'groupId': 'FG000', 'numUnits': '14', 'numSubjects': '14'}, {'groupId': 'FG001', 'numUnits': '14', 'numSubjects': '14'}]}, {'type': 'Timepoint 2 Assessment', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '12'}, {'groupId': 'FG001', 'numUnits': '13', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '12', 'numSubjects': '12'}, {'groupId': 'FG001', 'numUnits': '13', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numUnits': '3', 'numSubjects': '3'}, {'groupId': 'FG001', 'numUnits': '2', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'No baseline survey provided. Needed for target child selection.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Target child relocation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'typeUnitsAnalyzed': 'classrooms', 'recruitmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Peer Mediated Pivotal Response Intervention', 'description': '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.\n\nPeer-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'}, {'id': 'BG001', 'title': 'Control', 'description': 'Business as usual'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.42', 'spread': '8.37', 'groupId': 'BG000'}, {'value': '51.77', 'spread': '11.04', 'groupId': 'BG001'}, {'value': '51.12', 'spread': '9.67', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'months', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race and Ethnicity', 'categories': [{'title': 'Black non-hispanic', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'White non-Hispanic', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}, {'title': 'Hispanic', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Multiracial-non-Hispanic', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Preschool Language Screener 5 GROWTH SCALE VALUE', 'classes': [{'categories': [{'measurements': [{'value': '437.09', 'spread': '38.55', 'groupId': 'BG000'}, {'value': '455.38', 'spread': '53.40', 'groupId': 'BG001'}, {'value': '447', 'spread': '47.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'This excludes children who attrited from the project as summarized in the participant flow section of this report.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-04-01', 'size': 209485, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-05-22T10:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2023-12-04', 'resultsFirstSubmitDate': '2024-05-28', 'studyFirstSubmitQcDate': '2023-12-13', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-01-15', 'studyFirstPostDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Preschool Language Screener 5 (PLS-5) - Growth Scale Value', 'timeFrame': 'at baseline, 3 months, and 9 months', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Developmental Pragmatic Profile (DPP)', 'timeFrame': 'at baseline and 9 months, month 9 reported', 'description': '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.'}, {'measure': 'Teacher-Child Rating Scale (TCRS)', 'timeFrame': 'at baseline, and 9 months, month 9 reported', 'description': "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.\n\nAssertiveness 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)\n\nHigher scores indicate higher skills as measured by each subscale."}, {'measure': 'Peer Incoming Talk', 'timeFrame': 'through study completion, an average of 9 months, month 9 reported', 'description': '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.'}, {'measure': 'Peer Outgoing Talk', 'timeFrame': 'through study completion, an average of 9 months, month 9 reported', 'description': '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.'}, {'measure': 'Peer Interactions', 'timeFrame': 'through study completion, an average of 9 months, final observation (up to 9 months) reported', 'description': "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."}, {'measure': 'Play Interactions', 'timeFrame': 'through study completion, an average of 9 months; final observation (up to 9 months) reported', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Peer Influence']}, 'referencesModule': {'references': [{'pmid': '38048318', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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.\n\nFirst, 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '66 Months', 'minimumAge': '36 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'General Inclusion Criteria\n\n* teacher informed consent\n* caregiver informed consent\n* 36 months of age or older.\n\nExclusion Criteria:\n\n* no caregiver informed consent\n* younger than 36 months of age'}, 'identificationModule': {'nctId': 'NCT06182033', 'acronym': 'PEERS', 'briefTitle': 'Penetrating the Classroom Social Network for Children With Language Impairment Via Peer Mediated Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Penetrating the Classroom Social Network for Children With Language Impairment Via Peer Mediated Intervention', 'orgStudyIdInfo': {'id': 'R21DC018395', 'link': 'https://reporter.nih.gov/quickSearch/R21DC018395', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Peer-mediated pivotal response intervention', 'description': '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.', 'interventionNames': ['Behavioral: Peer-mediated pivotal response training']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Business as usual'}], 'interventions': [{'name': 'Peer-mediated pivotal response training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Peer-mediated pivotal response intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43201', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Crane Center for Early Childhood Research and Policy', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Laura M Justice, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}