Nctid:
NCT06227403
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-02"}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"], "maskingDescription"=>"Outcomes assessors will be masked to study condition."}, "primaryPurpose"=>"PREVENTION", "interventionModel"=>"PARALLEL", "interventionModelDescription"=>"Randomized Control Trial"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>40}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-12-15", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2024-05-01", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-17", "studyFirstSubmitDate"=>"2024-01-05", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-05-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Mental Health Continuum - Short Form", "timeFrame"=>"Baseline, 2-3 months", "description"=>"14-item, 6-point scale that measures emotional, social, and psychological wellbeing through frequency of experiencing each symptom of positive mental health. The scale range is 0-70, higher scores indicate better mental health."}, {"measure"=>"Engagement, Perseverance, Optimism, Connectedness, and Happiness (EPOCH) measure of adolescent wellbeing", "timeFrame"=>"Baseline, 2-3 months", "description"=>"20-item, 5-point scale measuring five positive characteristics that support higher levels of wellbeing: Engagement, Perseverance, Optimism, Connectedness, and Happiness. The scale range is 1-5, higher scores indicate better wellbeing."}, {"measure"=>"Social Emotional Health Survey: Belief in Self-Domain", "timeFrame"=>"Baseline, 2-3 months", "description"=>"9 item, 4-point measure of core psychological assets, measuring self-efficacy, self-awareness, and persistence. The scale range is 9-36, higher scores indicate better social emotional health."}, {"measure"=>"Strengths and Difficulties Questionnaire", "timeFrame"=>"Baseline, 2-3 months", "description"=>"25 item multiple choice questionnaire that measures internalizing and externalizing problems and prosocial behavior (emotional, conduct, hyperactivity-inattention, peer, prosocial). The scale range is 0-40, higher scores indicate worse difficulties."}, {"measure"=>"Self-Rated Health", "timeFrame"=>"Baseline, 2-3 months", "description"=>"12 item 5-point survey measuring general health, asking about overall health self-rating, ability to do daily activities, energy levels, and physical and emotional limitations. The scale range is 0-100, higher scores indicate better health."}, {"measure"=>"Student Career Construction Inventory", "timeFrame"=>"Baseline, 2-3 months", "description"=>"An 18 item, 4-point scale measuring ability to crystallize vocational self-concepts, explore information gathering about occupations, and preparing to implement that choice. The scale range is 1-5, higher scores indicate better career outcomes."}, {"measure"=>"Vocational Skills Self-Efficacy", "timeFrame"=>"Baseline, 2-3 months", "description"=>"A 37 item, 5-point scale that measures vocational competency. The scale range is 1-5, higher scores indicate better vocational skills self-efficacy."}, {"measure"=>"Information and Communications Technology (ICT) Literacy Pretest-Posttest", "timeFrame"=>"Baseline, 2-3 months", "description"=>"A 35 item multiple choice questionnaire that measures understanding of tools/mechanics of the internet, research processes, and application to career research. The scale range is 0-29, higher scores indicate better ICT literacy."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["mindfulness", "civic engagement", "youth leadership", "youth wellbeing"], "conditions"=>["Adolescent Behavior", "Mental Health Wellness 1"]}, "descriptionModule"=>{"briefSummary"=>"The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities and to address barriers to equity, through the acquisition of civic leadership and development skills as well as mindfulness practice, LEAP-M: Leadership, Engagement, and youth Activism Program with Mindfulness.\n\nThe goal of our proposal is to determine whether the Leadership, Engagement, and youth Activism Program with Mindfulness.(LEAP-M) curriculum, which was developed with youth of color, is a feasible and effective intervention for fostering civic leadership, civic development, and wellbeing. We seek to understand whether LEAP-M can support wellbeing for youth of color as a strategy to combat structural racism at the school- and neighborhood-levels, increase youth mental, emotional, and behavioral (MEB) health and decrease health disparities in youth of color.", "detailedDescription"=>"The LEAP-M study will determine whether a 14-session program designed to provide leadership and mindfulness skills to youth of color is an effective and feasible intervention. The curriculum consists of 14 two-hour sessions delivered after school. The comparison group will take part in EnvisionIT, a college and career readiness program designed for students in grades 6 through 12. EnvisionIT aims to prepare students with essential transition skills, digital literacy, and college and career readiness. The comparison group will also have 14 two-hour group sessions. Both LEAP-M and EnvisionIT will be delivered by trained facilitators. All participants in LEAP-M and EnvisionIT will be assessed at two time points assessing program outcomes; facilitators will also complete interviews post-intervention and provide feedback on data fidelity and acceptability following each session. This record reports on the UG3 pilot phase and will be amended for a UH3 phase."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT"], "maximumAge"=>"18 years", "minimumAge"=>"14 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n• Adolescents ages 14-18 in grades 9-12 enrolled in collaborating sites, either at Metropolitan Council for Educational Opportunity (METCO) in Boston, MA, or University of Illinois/Chicago Public School.\n\nExclusion Criteria:\n\n* Adolescents who are not available to commit to the intervention schedule.\n* Adolescents who are not in grades 9-12.\n* Parents/guardians with preferred language other than English or Spanish."}, "identificationModule"=>{"nctId"=>"NCT06227403", "briefTitle"=>"Leadership, Engagement, and Youth Activism Program With Mindfulness (LEAP)", "organization"=>{"class"=>"OTHER", "fullName"=>"Boston University Charles River Campus"}, "officialTitle"=>"Can A Youth Civic Leadership, Engagement, and Mindfulness Program Reduce Structural Racism and Support Functioning and Wellbeing for Youth of Color?", "orgStudyIdInfo"=>{"id"=>"1UG3AT012530-01", "link"=>"https://reporter.nih.gov/quickSearch/1UG3AT012530-01", "type"=>"NIH"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Leadership, Engagement, and youth Activism Program with Mindfulness", "description"=>"The Leadership, Engagement, and youth Activism Program with Mindfulness intervention (LEAP-M) consists of 14 sessions focused on youth civic engagement, leadership, and mindfulness.", "interventionNames"=>["Behavioral: Leadership, Engagement, and youth Activism Program with Mindfulness"]}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"EnvisionIT", "description"=>"EnvisionIT is a college and career-readiness program designed for students in grades 6-12. The EnvisionIT program will be delivered over 14 sessions, and focus on skills and career/college readiness.", "interventionNames"=>["Behavioral: EnvisionIT"]}], "interventions"=>[{"name"=>"Leadership, Engagement, and youth Activism Program with Mindfulness", "type"=>"BEHAVIORAL", "description"=>"The Leadership, Engagement, and youth Activism Program with Mindfulness intervention (LEAP-M) was designed and co-created with youth to improve youth wellbeing by enhancing civic engagement and leadership opportunities and by developing mindfulness in day-to-day life. LEAP-M seeks to foster these improvements in youth of color as a strategy to combat structural racism encountered at school- and neighborhood-levels and to increase youth mental, emotional, and behavioral health. Youth voice is incorporated into the intervention, with facilitators leading the first 7 sessions, and youth leading the remainder.", "armGroupLabels"=>["Leadership, Engagement, and youth Activism Program with Mindfulness"]}, {"name"=>"EnvisionIT", "type"=>"BEHAVIORAL", "description"=>"Participants in this arm will receive 14 sessions of EnvisionIT training, focused on preparing students with essential transition skills and digital literacy through competency in information technology, financial literacy, English language arts skills, and college and career readiness. All sessions will be delivered by facilitators trained in EnvisionIT.", "armGroupLabels"=>["EnvisionIT"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"60608", "city"=>"Chicago", "state"=>"Illinois", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Dana Rusch, PhD", "role"=>"CONTACT", "email"=>"drusch1@uic.edu", "phone"=>"312-413-1708"}], "facility"=>"University of Illinois Chicago", "geoPoint"=>{"lat"=>41.85003, "lon"=>-87.65005}}, {"zip"=>"02119", "city"=>"Boston", "state"=>"Massachusetts", "status"=>"RECRUITING", "country"=>"United States", "contacts"=>[{"name"=>"Wilmary Tejeda, MPA", "role"=>"CONTACT", "email"=>"wtejeda@metcoinc.org", "phone"=>"617-427-1545", "phoneExt"=>"119"}], "facility"=>"METCO", "geoPoint"=>{"lat"=>42.35843, "lon"=>-71.05977}}], "centralContacts"=>[{"name"=>"Jennifer G Green, PhD", "role"=>"CONTACT", "email"=>"jggreen@bu.edu", "phone"=>"6173533253"}, {"name"=>"Mario Cruz-Gonzalez, PhD", "role"=>"CONTACT", "email"=>"mcruzgonzalez@mgh.harvard.edu", "phone"=>"6175138762"}], "overallOfficials"=>[{"name"=>"Jennifer G Green, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Boston University"}, {"name"=>"Mario Cruz-Gonzalez, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Massachusetts General Hospital"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO", "description"=>"Data for the study UG3 Phase are for pilot and feasibility purposes and will not be shared with other researchers."}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Boston University Charles River Campus", "class"=>"OTHER"}, "collaborators"=>[{"name"=>"Massachusetts General Hospital", "class"=>"OTHER"}, {"name"=>"University of Illinois at Chicago", "class"=>"OTHER"}, {"name"=>"Utah State University", "class"=>"OTHER"}], "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Professor, Wheelock College of Education & Human Development", "investigatorFullName"=>"Jennifer Greif Green", "investigatorAffiliation"=>"Boston University Charles River Campus"}}}}
