[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630104":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":48,"centralContacts":54,"locations":60,"responsibleParty":76,"collaborators":80,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":48,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":48,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":115,"overallStatus":126,"whyStopped":48,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":136},{"fullName":5,"class":6},"Ann & Robert H Lurie Children's Hospital of Chicago","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"SPARCS Group Therapy [Stage 1 Randomization]","EXPERIMENTAL","Participants are initially randomized to receive Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) in a group format. Participants who do not show sufficient improvement after Stage 1 will be re-randomized to Stage 2 individual therapy (SPARCS or Unified Protocol).",[13],"Behavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group",{"label":15,"type":10,"description":16,"interventionNames":17},"Unified Protocol Group Therapy [Stage 1 Randomization]","Participants are initially randomized to receive Unified Protocol (UP) in a group format. Participants who do not show sufficient improvement after Stage 1 will be re-randomized to Stage 2 individual therapy (SPARCS or UP).",[18],"Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group",{"label":20,"type":10,"description":21,"interventionNames":22},"SPARCS Individual Therapy for Non-Responders [Stage 2 Randomization]","Participants who do not show sufficient improvement after Stage 1 group therapy and are re-randomized to individual therapy receive Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) individual therapy. Sessions are tailored to participant needs and may include family involvement. Treatment duration is guided by participant response, with booster sessions as needed.",[23],"Behavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual",{"label":25,"type":10,"description":26,"interventionNames":27},"UP Individual Therapy for Non-Responders [Stage 2 Randomization]","Participants who do not show sufficient improvement after Stage 1 group therapy and are re-randomized to individual therapy receive Unified Protocol individual therapy. Sessions are tailored to participant needs. Treatment duration is guided by participant response, with booster sessions as needed.",[28],"Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual",[30,37,44,49],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BEHAVIORAL","Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group","SPARCS is a manualized, cognitive-behavioral group program for youth (12-21 years) exposed to chronic interpersonal trauma or multiple trauma types, including community and domestic violence. The program is strength-based and present-focused, with adolescent-tailored content targeting affect regulation, impulsivity, self-perception, relationships, somatic symptoms, dissociation, avoidance, and challenges with personal purpose or worldview. SPARCS supports emotional, social, academic, and behavioral functioning and is appropriate for youth with or without PTSD experiencing ongoing trauma-related stress. Group sessions are delivered over 12-16 weekly, in-person sessions by licensed mental health providers.",[9],[36],"SPARCS",{"type":31,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group","The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP) is a manualized, transdiagnostic cognitive-behavioral intervention for youth with emotional disorders, including trauma-related distress. UP targets underlying emotion regulation processes across anxiety, depression, and related symptoms. Group sessions teach participants to identify, understand, and modify maladaptive emotional responses while promoting adaptive coping. Core components include mindful emotional awareness, cognitive flexibility, exposure to avoided emotions, and behavioral activation. UP has been shown effective for youth with trauma-related distress and youth with chronic medical conditions. Group sessions are delivered over 12-16 weekly, in-person sessions by licensed mental health providers.",[15],[42,43],"UP","Unified Protocol",{"type":31,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual","The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP) is a manualized, transdiagnostic cognitive-behavioral intervention for youth with emotional disorders, including trauma-related distress. UP can be delivered in group or individual formats and targets underlying emotion regulation processes across anxiety, depression, and related symptoms. Sessions teach participants to identify, understand, and modify maladaptive emotional responses while promoting adaptive coping. Core components include mindful emotional awareness, cognitive flexibility, exposure to avoided emotions, and behavioral activation. UP has been shown to be effective for youth with trauma-related distress and youth with chronic medical conditions. Sessions are typically held weekly, with duration guided by participant response and maintenance or booster sessions provided as needed.",[25],null,{"type":31,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual","SPARCS Individual is a manualized, skills-based cognitive-behavioral intervention for youth (12-21 years) exposed to chronic interpersonal trauma or multiple trauma types. Individual sessions are tailored to each participant's clinical needs, targeting affect regulation, impulsivity, self-perception, relationships, somatic symptoms, dissociation, avoidance, and challenges with personal purpose or worldview. Individual therapy may involve family participation and supports emotional, social, academic, and behavioral functioning. Sessions are typically held weekly, with duration guided by participant response and maintenance or booster sessions provided as needed.",[20],[36],[55],{"name":56,"role":57,"phone":58,"phoneExt":48,"email":59},"Anthony T. Vesco, PhD","CONTACT","312-227-5075","avesco@luriechildrens.org",[61],{"facility":62,"status":48,"city":63,"state":64,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"Ann & Robert H. Lurie Children's Hospital of Chicago","Chicago","Illinois","60611","United States","US",{"type":69,"coordinates":70},"Point",[71,72],-87.65005,41.85003,{"lat":72,"lon":71},[75],{"name":56,"role":57,"phone":58,"phoneExt":48,"email":59},{"type":77,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"SPONSOR_INVESTIGATOR","Anthony Vesco","Associate Professor of Psychiatry and Behavioral Sciences (Child and Adolescent Psychiatry)",[81,84],{"name":82,"class":83},"Substance Abuse and Mental Health Services Administration (SAMHSA)","FED",{"name":85,"class":6},"Northwestern University","100630104","comparative-effectiveness-of-sparcs-and-unified-protocol-for-youth-with-chronic-medical-conditions-and-trauma-related-distress-100630104",false,"NCT07483333","Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress","Supporting Purposeful Interventions & Resilience In Trauma (SPIRIT) Program: Implementing Trauma-Specific Screening and Stratified Interventions for Youth With a Chronic Medical Condition","Inclusion Criteria:\n\n* Youth (aged 8-18 years) who received a SPIRIT program psychological trauma screening and were deemed clinically appropriate for SPIRIT group therapy. Clinically appropriate means the youth can historically engage in a group setting (e.g., school, camp, therapy group) without significant disruption to the group process or other participants.\n* Youth and parent\u002Flegal guardian are willing and able to provide informed consent\u002Fassent for randomization.\n* Youth and parent\u002Flegal guardian are fluent in English or Spanish.\n* Youth is not currently engaged in individual therapy at the time of enrollment (per patient\u002Fparent report).\n\nExclusion Criteria:\n\n* Wards of the state or DCFS youth in care.\n* Youth with reported or observed symptoms that would significantly impair group therapy engagement, including but not limited to: intellectual disability, moderate-to-severe autism spectrum disorder, active suicidal ideation, uncontrolled psychosis, or other acute psychiatric symptoms that could disrupt the group process.\n* Regular use of alcohol or other substances that interfere with participation or disrupt the group process.\n* Youth requiring immediate higher-level psychiatric care (e.g., intensive outpatient programming, partial hospitalization, inpatient psychiatric admission, or residential treatment) at the time of first randomization.","ALL","8 Years","18 Years",{"count":97,"type":98},400,"ESTIMATED","INTERVENTIONAL",[101],"NA","The goal of this clinical trial is to compare the effectiveness of trauma-focused therapies for improving mental health symptoms and daily functioning in youth with chronic medical conditions who have experienced psychological trauma and trauma-related distress. The study evaluates two evidence-based cognitive-behavioral therapies - Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) and the Unified Protocol (UP) - delivered in group and individual formats to determine which approach, or combination of approaches, best reduces trauma symptoms and supports coping and adjustment. The study will also help researchers understand how to best support youth who continue to experience distress after an initial round of therapy.\n\nThe main questions it aims to answer are:\n\n* Does SPARCS group therapy or UP group therapy lead to greater improvements in trauma symptoms and functional impairment?\n* For youth who do not show enough improvement after group therapy, does adding SPARCS or UP individual therapy lead to better outcomes?\n* Which sequence of group and individual therapies leads to the greatest improvements in trauma symptoms and functioning?\n\nResearchers will compare two evidence-based therapies currently offered at Ann \\& Robert H. Lurie Children's Hospital of Chicago. Youth will first be randomly assigned to receive either SPARCS or UP in a group format. After completing group therapy, youth who still need additional support will be randomly assigned again to receive individual or family therapy using SPARCS or UP. This stepwise approach will help identify which sequence of therapies leads to the best overall outcomes for youth.\n\nParticipants will:\n\n* Take part in group therapy sessions using either SPARCS or UP\n* For those needing additional support after group therapy, participate in individual SPARCS or UP therapy\n* Complete brief assessments of mental health and daily functioning at enrollment, and every 12 weeks thereafter for 48 weeks, as part of their regular care through Ann \\& Robert H. Lurie Children's Supporting Purposeful Interventions \\& Resilience in Trauma (SPIRIT) program",[104,105,106,107,108,109,110,111,112,113,114],"Trauma Exposure","Trauma","Trauma and Stressor Related Disorder","Mental Health Functioning","Chronic Medical Conditions","Chronic Medical Condition","Chronic Medical Illness","Posttraumatic Stress Disorder PTSD","Posttraumatic Stress Disorders","Posttraumatic Stress Symptoms","Posttraumatic Stress",[116,117,118,119,120,121,122,123,124,43,125],"pediatric trauma","posttraumatic stress disorder","chronic medical conditions","pediatrics","trauma symptoms","trauma and stressor related disorder","trauma informed care","Sequential, Multiple Assignment Randomized Trial","Supporting Purposeful Interventions and Resilience in Trauma","Structured Psychotherapy for Adolescents Responding to Chronic Stress","NOT_YET_RECRUITING","2026-03-16",{"date":129,"type":130},"2026-03-19","ACTUAL",{"date":132,"type":98},"2026-07",{"date":134,"type":98},"2029-09-29",{"name":78,"class":6},1]