Ignite Creation Date:
2025-12-24 @ 4:47 PM
Ignite Modification Date:
2026-01-18 @ 1:17 AM
Study NCT ID:
NCT06017050
Status:
COMPLETED
Last Update Posted:
2025-12-05
First Post:
2023-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058445', 'term': 'Bullying'}], 'ancestors': [{'id': 'D000374', 'term': 'Aggression'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000071277', 'term': 'Harassment, Non-Sexual'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michele@innovativepublichealth.org', 'phone': '8773026858', 'title': 'Michele Ybarra', 'phoneExt': '801', 'organization': 'Center for Innovative Public Health Research'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Each participant was followed for 21 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'BullyDown intervention', 'description': 'BullyDown: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.', 'otherNumAtRisk': 71, 'deathsNumAtRisk': 71, 'otherNumAffected': 0, 'seriousNumAtRisk': 71, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Healthy lifestyle control', 'description': "Attention-matched control: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use.", 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 0, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility: Recruitment Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '474', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall Number of Participants Recruited', 'description': 'Overall Number of Participants Recruited represent all participants who were determined to be eligible to be included in the study'}], 'classes': [{'categories': [{'measurements': [{'value': '202', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Recruitment period', 'description': 'If at least 75% of eligible participants assent to participate, this will be supportive of a hypothesis of feasibility. Note that a youth could assent and not be randomized if they did not complete the baseline survey.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '474 youth were identified as eligible.'}, {'type': 'PRIMARY', 'title': 'Acceptability of the Intervention', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BullyDown intervention', 'description': 'BullyDown: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.'}, {'id': 'OG001', 'title': 'Healthy lifestyle control', 'description': "Attention-matched control: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use."}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Intervention end, 9 weeks after program enrollment', 'description': 'Youth were asked: "How likely are you to recommend BullyDown to other people your age?" Answers were collected on a 5-point Likert scale. The response option ranged from 1-5, with higher values reflecting greater acceptability. An average score of 4 or higher was deemed supportive of program acceptability.', 'unitOfMeasure': 'Average score on a 5-point likert scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Youth who provided data at the program end survey were included in the analyses.'}, {'type': 'PRIMARY', 'title': 'Feasibility: Retention at 3-month Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BullyDown intervention', 'description': 'BullyDown: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.'}, {'id': 'OG001', 'title': 'Healthy lifestyle control', 'description': "Attention-matched control: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use."}], 'classes': [{'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '21 weeks post-randomization, 3 months after the 9-week program ended', 'description': 'A retention rate of 80% or higher was deemed to be supportive of a hypothesis of feasibility', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feasibility: Retention Rate at Program End', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BullyDown intervention', 'description': 'BullyDown: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.'}, {'id': 'OG001', 'title': 'Healthy lifestyle control', 'description': "Attention-matched control: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use."}], 'classes': [{'categories': [{'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '9 weeks post-randomization', 'description': 'A retention rate of 80% or higher was deemed supportive of a hypothesis of feasibility.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rates of Bullying Perpetration in the Intervention Versus Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BullyDown intervention', 'description': 'BullyDown: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.'}, {'id': 'OG001', 'title': 'Healthy lifestyle control', 'description': "Attention-matched control: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use."}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Reported bullying perpetration behavior in the past 30 days at the end of the 9 week program', 'description': 'Bullying behaviors towards other youth the same age 3 or more times in the past 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Youth who provided data at the program end survey were included in the analyses.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Rates of Aggressive Behavior in the Intervention Versus Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BullyDown intervention', 'description': 'BullyDown: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.'}, {'id': 'OG001', 'title': 'Healthy lifestyle control', 'description': "Attention-matched control: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use."}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Reported aggressive behavior in the past 30 days at the end of the 9 week program', 'description': 'Youth who report aggressive acts towards others 1-2 times in the past 30 days', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Youth who provided data at the program end survey were included in the analyses.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Scores of Bystanding Behavior in the Intervention Versus Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BullyDown intervention', 'description': 'BullyDown: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.'}, {'id': 'OG001', 'title': 'Healthy lifestyle control', 'description': "Attention-matched control: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use."}], 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '2.9', 'groupId': 'OG000'}, {'value': '15.0', 'spread': '3.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Responses provided at the program end survey, 9 weeks after they were randomized', 'description': 'Bystander intentions are measured using the 5-item University of Illinois Willingness to Intervene scale. Each of the items is measured on a 4-point Likert scale, resulting in a sum that ranges from 5 - 20. A higher score reflects a greater willingness to intervene.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Youth who provided data at the program end survey were included in the analyses.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BullyDown intervention', 'description': 'BullyDown: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.'}, {'id': 'FG001', 'title': 'Healthy lifestyle control', 'description': "Attention-matched control: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'BullyDown Intervention', 'description': 'BullyDown: BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.'}, {'id': 'BG001', 'title': 'Healthy Lifestyle Control', 'description': "Attention-matched control: The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '71', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Boys', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}, {'title': 'Girls', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}, {'title': 'Nonbinary youth', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Declined to answer', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '104', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '82', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Bullying perpetration', 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Bullying is defined as engaging in at least one of 6 behaviors 3 or more times in the past 30 days. The behaviors include: 1) Hitting, kicking, pushing or shoving someone; 2) Making threatening or aggressive comments to someone; 3) Calling someone mean names; 4) Making fun of someone or teasing someone in a nasty way; 5) Leaving someone out or not letting someone into a group because you were mad at someone or were trying to make someone upset; and 6) Spreading rumors about someone, whether they were true or not.', 'unitOfMeasure': 'Participants'}, {'title': 'Aggression perpetration', 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Aggressive behavior is defined as engaging in at least one of 6 behaviors 1-2 times in the past 30 days. The behaviors include: 1) Hitting, kicking, pushing or shoving someone; 2) Making threatening or aggressive comments to someone; 3) Calling someone mean names; 4) Making fun of someone or teasing someone in a nasty way; 5) Leaving someone out or not letting someone into a group because you were mad at someone or were trying to make someone upset; and 6) Spreading rumors about someone, whether they were true or not.', 'unitOfMeasure': 'Participants'}, {'title': 'Bystander behavior', 'classes': [{'categories': [{'measurements': [{'value': '14.7', 'spread': '2.4', 'groupId': 'BG000'}, {'value': '15.3', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '15.0', 'spread': '2.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Bystander intentions are measured using the 5-item University of Illinois Willingness to Intervene scale. Each of the items is measured on a 4-point Likert scale, resulting in a sum that ranges from 5 - 20. A higher score reflects a greater willingness to intervene.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-10-06', 'size': 231006, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-01T17:20', 'hasProtocol': True}, {'date': '2023-04-05', 'size': 137635, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-08-16T14:43', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Youth assigned to the control group will receive message written to seem as if it is intervention content (i.e., address bullying behaviors).'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Youth will be randomized to either the intervention or control group.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2023-08-16', 'resultsFirstSubmitDate': '2025-06-13', 'studyFirstSubmitQcDate': '2023-08-25', 'lastUpdatePostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-12-02', 'studyFirstPostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-06-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Rates of Bullying Perpetration in the Intervention Versus Control Group', 'timeFrame': 'Reported bullying perpetration behavior in the past 30 days at the end of the 9 week program', 'description': 'Bullying behaviors towards other youth the same age 3 or more times in the past 30 days'}, {'measure': 'Rates of Aggressive Behavior in the Intervention Versus Control Group', 'timeFrame': 'Reported aggressive behavior in the past 30 days at the end of the 9 week program', 'description': 'Youth who report aggressive acts towards others 1-2 times in the past 30 days'}, {'measure': 'Scores of Bystanding Behavior in the Intervention Versus Control Group', 'timeFrame': 'Responses provided at the program end survey, 9 weeks after they were randomized', 'description': 'Bystander intentions are measured using the 5-item University of Illinois Willingness to Intervene scale. Each of the items is measured on a 4-point Likert scale, resulting in a sum that ranges from 5 - 20. A higher score reflects a greater willingness to intervene.'}], 'primaryOutcomes': [{'measure': 'Feasibility: Recruitment Rate', 'timeFrame': 'Recruitment period', 'description': 'If at least 75% of eligible participants assent to participate, this will be supportive of a hypothesis of feasibility. Note that a youth could assent and not be randomized if they did not complete the baseline survey.'}, {'measure': 'Acceptability of the Intervention', 'timeFrame': 'Intervention end, 9 weeks after program enrollment', 'description': 'Youth were asked: "How likely are you to recommend BullyDown to other people your age?" Answers were collected on a 5-point Likert scale. The response option ranged from 1-5, with higher values reflecting greater acceptability. An average score of 4 or higher was deemed supportive of program acceptability.'}, {'measure': 'Feasibility: Retention at 3-month Follow-up', 'timeFrame': '21 weeks post-randomization, 3 months after the 9-week program ended', 'description': 'A retention rate of 80% or higher was deemed to be supportive of a hypothesis of feasibility'}], 'secondaryOutcomes': [{'measure': 'Feasibility: Retention Rate at Program End', 'timeFrame': '9 weeks post-randomization', 'description': 'A retention rate of 80% or higher was deemed supportive of a hypothesis of feasibility.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bullying']}, 'descriptionModule': {'briefSummary': 'Given the limited impact of existing school-based interventions and the time associated with implementing them during school time, more efficient and effective intervention methods are needed. Programs that can be delivered to middle school youth irrespective of whether they are attending school physically or virtually may be especially relevant as school boundaries become more fluid. BullyDown addresses this critical need by providing a scalable program that could be quickly and cost-effectively disseminated nationally.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Participants will: be enrolled in one of our partner schools, be in middle school (i.e., 7th or 8th grade) or between the ages of 12-14 years of age, be English-speaking, own their own cell phone, intend to have the same cell phone number for at least 3 months (this may or may not apply, depending on the number of youth who meet this criterion), and provide informed written assent. Non-English speakers and youth who do not have the reading ability to complete the screener are not eligible. Youth recruited from schools will also be required to have parental permission.'}, 'identificationModule': {'nctId': 'NCT06017050', 'briefTitle': 'BullyDown, a Text Messaging-based Bullying Prevention Program for Middle School-aged Youth', 'organization': {'class': 'OTHER', 'fullName': 'Center for Innovative Public Health Research'}, 'officialTitle': 'Developing a Bullying Prevention Program That Transcends Physical Boundaries', 'orgStudyIdInfo': {'id': 'R21HD104369', 'link': 'https://reporter.nih.gov/quickSearch/R21HD104369', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'R21HD104369', 'link': 'https://reporter.nih.gov/quickSearch/R21HD104369', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BullyDown intervention', 'interventionNames': ['Behavioral: BullyDown']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Healthy lifestyle control', 'interventionNames': ['Behavioral: Attention-matched control']}], 'interventions': [{'name': 'BullyDown', 'type': 'BEHAVIORAL', 'description': 'BullyDown is an 8 week, text messaging-based prevention program aimed to prevent bullying behaviors among middle school-aged youth. Message content is based upon the social-emotional learning model.', 'armGroupLabels': ['BullyDown intervention']}, {'name': 'Attention-matched control', 'type': 'BEHAVIORAL', 'description': "The attention-matched control will receive the messages for the same number of days as the intervention. Content will talk about 'healthy lifestyle' topics, such as fitness and healthy social media use.", 'armGroupLabels': ['Healthy lifestyle control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92672-6745', 'city': 'San Clemente', 'state': 'California', 'country': 'United States', 'facility': 'Center for Innovative Public Health Research', 'geoPoint': {'lat': 33.42697, 'lon': -117.61199}}, {'zip': '27599-2100', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Center for Innovative Public Health Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, {'name': 'Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}