[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100499914":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":39,"responsibleParty":111,"collaborators":18,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":18,"eligibilityCriteria":120,"healthyVolunteers":121,"sex":122,"minAge":123,"maxAge":18,"enrollmentInfo":124,"targetDuration":18,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":135,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Penn State University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BaSICS Intervention","EXPERIMENTAL","Intervention = Building a String Identity and Coping Skills (BaSICS). Children randomized to participate in 16 twice weekly BaSICS intervention sessions. Children learn coping skills, identity development, and collective action as ways to buffer against chronic stress.\n\nThese children also complete pre- and post-intervention assessments, as well as 6-month and 12-month follow-up assessments.",[13],"Behavioral: Building a Strong Identity and Coping Skills",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","NO_INTERVENTION","These children complete assessments only--timed to coincide with the intervention groups' assessments: pre- and post-intervention assessments, as well as 6-month and 12-month follow-up assessments. No intervention.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","Building a Strong Identity and Coping Skills","Psychoeducational program to teach children coping skills, healthy identity development, and collective social action",[9],[26],"BaSICS",[28],{"name":29,"affiliation":5,"role":30},"Martha E Wadsworth, PhD","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":18,"email":35},"CONTACT","814-865-2878","mew27@psu.edu",{"name":37,"role":33,"phone":18,"phoneExt":18,"email":38},"Dara Babinksi, PhD","dbabinski@pennstatehealth.psu.edu",[40,58,73,86,101],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Pennsylvania Psychiatric Institute","NOT_YET_RECRUITING","Harrisburg","Pennsylvania","17110","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-76.88442,40.2737,{"lat":52,"lon":51},[55],{"name":56,"role":33,"phone":18,"phoneExt":18,"email":57},"Jasmin Lagman, MD","jlagman@pennstatehealth.psu.edu",{"facility":59,"status":60,"city":61,"state":44,"zip":62,"country":46,"countryCode":47,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Penn State Health Medical Group - Psychiatry and Behavioral Health","RECRUITING","Hershey","17033",{"type":49,"coordinates":64},[65,66],-76.65025,40.28592,{"lat":66,"lon":65},[69,71],{"name":70,"role":33,"phone":18,"phoneExt":18,"email":38},"Dara Babinski, PhD",{"name":72,"role":30,"phone":18,"phoneExt":18,"email":18},"Dara Babinski, Ph.D.",{"facility":74,"status":42,"city":75,"state":44,"zip":76,"country":46,"countryCode":47,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Penns Valley Area School District","Spring Mills","16875",{"type":49,"coordinates":78},[79,80],-77.5675,40.8534,{"lat":80,"lon":79},[83],{"name":84,"role":33,"phone":18,"phoneExt":18,"email":85},"Kurt Nyquist","knyquist@pennsvalley.org",{"facility":87,"status":60,"city":88,"state":44,"zip":89,"country":46,"countryCode":47,"cosmosGeoPoint":90,"geoPoint":94,"contacts":95},"Dr. Edwin L. Herr Clinic","State College","16802",{"type":49,"coordinates":91},[92,93],-77.86,40.79339,{"lat":93,"lon":92},[96,99],{"name":97,"role":33,"phone":18,"phoneExt":18,"email":98},"Kristen Nadermann, PhD","kmc452@psu.edu",{"name":100,"role":30,"phone":18,"phoneExt":18,"email":18},"Martha Wadsworth, Ph.D.",{"facility":102,"status":60,"city":88,"state":44,"zip":89,"country":46,"countryCode":47,"cosmosGeoPoint":103,"geoPoint":105,"contacts":106},"Penn State Psychological Clinic",{"type":49,"coordinates":104},[92,93],{"lat":93,"lon":92},[107,110],{"name":108,"role":33,"phone":18,"phoneExt":18,"email":109},"Estee Hausman, PhD","exh471@psu.edu",{"name":100,"role":30,"phone":18,"phoneExt":18,"email":18},{"type":30,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Martha E. Wadsworth","Professor of Psychology","100499914","confirmatory-efficacy-of-the-building-a-strong-identity-and-coping-skills-program-100499914",false,"NCT05789446","Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program","Confirmatory Efficacy of the Building a Strong Identity and Coping Skills Program for Low-income and Minoritized Young Adolescents","Inclusion Criteria:\n\n* Children ages 11-14 at intake\n* Family income at or below 200% federal poverty level\n* Child speaks English\n* Parent speaks English or Spanish\n\nExclusion Criteria:\n\n* Intellectual disability\n* Autism spectrum disorder\n* High suicidal risk (score of 17 or more on the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-Kid))\n* Severe depression (score of 19 or more on Patient health questionnaire (PHQ).",true,"ALL","11 Years",{"count":125,"type":126},360,"ESTIMATED","INTERVENTIONAL",[129],"NA","The goal of this clinical trial is to the efficacy of the Building a Strong Identity and Coping Skills intervention within a sample of low-income and minoritized youth aged 11-14 who are seeking mental health treatment and have been placed on a waitlist to receive services.\n\nThe aims of this study are to: (1) confirm the efficacy of BaSICS by replicating previous findings, (2) Examine the changes of coping mechanisms and symptom change over the course of the BaSICS intervention, and (3) test models of physiologic stress reactivity and regulation to capture biological \"risk\" and recalibration.\n\nCohorts of 20 participants will randomly be enrolled in either the intervention (10) or control (10) groups. Participants enrolled in the intervention group will complete the BaSICS program and participants enrolled in the no intervention group will not be enrolled in the intervention program. The BaSICS program is designed to help treat anxiety, depression, and post-traumatic stress symptoms and disorders and have direct effects on physiologic stress response systems (hypothalamic-pituitary-adrenal (HPA) axis). Researchers will compare the intervention and no intervention groups to see if there is a difference in the reduction of markers for anxiety, depression, and suicide scores, changes in coping mechanism, and HPA reactivity profiles",[132,133,134],"Chronic Stress","Anxiety","Depression",[136,137,138,139],"Poverty","Discrimination","Stress","Coping","2025-04-11",{"date":142,"type":143},"2025-04-16","ACTUAL",{"date":145,"type":143},"2025-02-01",{"date":147,"type":126},"2029-05-31",{"name":5,"class":6},5]