Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 1:08 PM
Study NCT ID:
NCT07483333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-19
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Sequential multiple assignment randomized trial (SMART)'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2029-09-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-16', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-03-16', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pediatric Traumatic Stress Screening Tool (Caregiver Report)', 'timeFrame': 'Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.', 'description': 'A 12-item caregiver-report measure assessing youth posttraumatic stress symptoms related to any endorsed psychological trauma exposure. Designed to assist clinicians in evaluating and diagnosing posttraumatic stress disorder (PTSD). Caregiver respondents rate the frequency of traumatic stress symptoms in their child over the past month (e.g., "When something reminds my child of what happened, he/she has strong feelings in his/her body, like his/her heart beats fast, headaches or stomach aches") using a 5-point Likert scale. Items are summed to calculate a sum score, ranging from 0 to 48, with higher scores indicating higher levels of traumatic stress symptoms, and scores of 21 or greater indicate clinically elevated ("probable PTSD") traumatic stress symptoms.'}, {'measure': 'Pediatric Traumatic Stress Screening Tool (Youth Self-Report)', 'timeFrame': 'Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.', 'description': 'A 12-item self-report measure assessing posttraumatic stress symptoms related to any endorsed psychological trauma exposure. Designed to assist clinicians in evaluating and diagnosing posttraumatic stress disorder (PTSD). Youth respondents rate the frequency of traumatic stress symptoms they have experienced over the past month (e.g., "When something reminds me of what happened, I have strong feelings in my body, like my heart beats fast, headaches or stomach aches") using a 5-point Likert scale. Items are summed to calculate a sum score, ranging from 0 to 48, with higher scores indicating higher levels of traumatic stress symptoms, and scores of 21 or greater indicate clinically elevated ("probable PTSD") traumatic stress symptoms.'}, {'measure': "Revised Children's Anxiety and Depression Scale - 25", 'timeFrame': 'Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.', 'description': 'The Revised Children\'s Anxiety and Depression Scale -25 is a 25-item youth self-report measure assessing anxiety and depressive symptoms. Respondents rate the frequency with which they experience symptoms (e.g., "I feel sad or empty) using a 4-point Likert scale. Scores on individual items are summed to calculate depression (10 items; scores range from 0 to 30), anxiety (15 items; scores range from 0 to 45), and overall depression and anxiety (25 items; scores range from 0 to 75) sum scores. Higher scores indicate greater levels of depression and anxiety symptoms. Raw scores can be converted to t-scores using normed data based on child biological sex and age.'}, {'measure': "The Revised Children's Anxiety and Depression Scale - 25, Parent", 'timeFrame': 'Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.', 'description': 'The Revised Children\'s Anxiety and Depression Scale - 25, Parent is a 25-item measure assessing caregiver report of youth anxiety and depressive symptoms. Respondents rate the frequency with which their child experiences symptoms (e.g., "My child feels sad or empty) using a 4-point Likert scale. Scores on individual items are summed to calculate depression (10 items; scores range from 0 to 30), anxiety (15 items; scores range from 0 to 45), and overall depression and anxiety (25 items; scores range from 0 to 75) sum scores. Higher scores indicate greater levels of depression and anxiety symptoms. Raw scores can be converted to t-scores using normed data based on child biological sex and age.'}, {'measure': 'Ohio Scales for Youth Functioning Scale (Caregiver Report)', 'timeFrame': 'Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.', 'description': 'The Ohio Scales for Youth Functioning Scale (Caregiver Report) is a 20-item measure assessing caregiver report of youth functional impairment across settings and daily living. Respondents rate the degree of functional impairment children experience across everyday activities (e.g., "Controlling emotions and staying out of trouble"; "Getting along with friends") using a 5-point Likert scale. Scores on individual items are summed to calculate an overall functional impairment score, ranging from 0 to 100, in which lower scores indicate greater functional impairment in everyday activities. Scores at or below 50 are considered clinically elevated functional impairment.'}, {'measure': 'Ohio Scales for Youth Functioning Scale (Youth Self-Report)', 'timeFrame': 'Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.', 'description': 'The Ohio Scales for Youth Functioning Scale (Youth Self-Report) is a 20-item measure assessing self-report of youth functional impairment across settings and daily living. Respondents rate the degree of functional impairment they experience across everyday activities (e.g., "Controlling emotions and staying out of trouble"; "Getting along with friends") using a 5-point Likert scale. Scores on individual items are summed to calculate an overall functional impairment score, ranging from 0 to 100, in which lower scores indicate greater functional impairment in everyday activities. Scores at or below 60 are considered clinically elevated functional impairment.'}], 'secondaryOutcomes': [{'measure': 'Multidimensional Scale of Perceived Social Support (Youth Self-Report)', 'timeFrame': 'Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.', 'description': 'The Multidimensional Scale of Perceived Social Support is a 12-item self-report measure assessing perceived social support from friends, family, and significant others. Respondents rate the degree to which they agree with each statement (e.g., "My family really tries to help me") using a 7-point Likert scale. Mean scores are calculated across three subscales: friend support (4 items; scores range from 1 to 7), family support (4 items; scores range from 1 to 7), and significant other support (4 items; scores range from 1 to 7). An overall social support score is calculated by averaging responses across all 12 items (scores range from 1 to 7). Across all subscale and total scores, higher values indicate higher levels of perceived social support.'}, {'measure': 'Distress Tolerance Scale Youth Self-Report', 'timeFrame': 'Baseline; 12 weeks post-baseline; 24 weeks post-baseline; 36 weeks post-baseline; 48 weeks post-baseline.', 'description': 'The Distress Tolerance Scale is a 15-item self-report measure assessing individuals\' ability to tolerate uncomfortable emotional states, physical sensations, and emotion-related behavioral urges. Respondents rate the extent to which they agree with each statement (e.g., "Feeling upset or distressed is unbearable to me") using a 5-point Likert scale. When used with youth, 12 items are summed to create a total distress tolerance score; 11 of these items are reverse scored, and one item is not. Lower scores indicate greater distress tolerance.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['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', 'Unified Protocol', 'Structured Psychotherapy for Adolescents Responding to Chronic Stress'], 'conditions': ['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']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Simons, J. S., & Gaher, R. M. (2005). The Distress Tolerance Scale: Development and validation of a self-report measure. Motivation and emotion, 29(2), 83-102.'}, {'pmid': '31637572', 'type': 'BACKGROUND', 'citation': 'Tonarely NA, Ehrenreich-May J. Confirming the Factor Structure and Validity of the Distress Tolerance Scale (DTS) in Youth. Child Psychiatry Hum Dev. 2020 Aug;51(4):514-526. doi: 10.1007/s10578-019-00935-z.'}, {'pmid': '2280326', 'type': 'BACKGROUND', 'citation': 'Zimet GD, Powell SS, Farley GK, Werkman S, Berkoff KA. Psychometric characteristics of the Multidimensional Scale of Perceived Social Support. J Pers Assess. 1990 Winter;55(3-4):610-7. doi: 10.1080/00223891.1990.9674095.'}, {'type': 'BACKGROUND', 'citation': 'Ogles, B. M., Melendez, G., Davis, D. C., & Lunnen, K. M. (2001). The Ohio scales: Practical outcome assessment. Journal of Child and Family Studies, 10(2), 199-212.'}, {'pmid': '22329531', 'type': 'BACKGROUND', 'citation': 'Ebesutani C, Reise SP, Chorpita BF, Ale C, Regan J, Young J, Higa-McMillan C, Weisz JR. The Revised Child Anxiety and Depression Scale-Short Version: scale reduction via exploratory bifactor modeling of the broad anxiety factor. Psychol Assess. 2012 Dec;24(4):833-45. doi: 10.1037/a0027283. Epub 2012 Feb 13.'}, {'pmid': '40770654', 'type': 'BACKGROUND', 'citation': 'Botchway-Commey E, DPsych CB, Pace C, Ehrenreich-May J, Kennedy SM, Williams J, DPsychClin ZP, DPsychClin AM, Anderson V, Crowe L. A waitlist randomised control trial of the unified protocol for the treatment of emotional disorders in children and adolescents with chronic medical conditions (The UP-CAM Study): protocol paper. BMC Psychol. 2025 Aug 6;13(1):873. doi: 10.1186/s40359-025-03052-w.'}, {'type': 'BACKGROUND', 'citation': 'Lindenbach, D., Anderson, A., Wang, E., Heintz, M., Rowbotham, M., Ehrenreich-May, J., Arnold, P., & Dimitropoulos, G. (2025). Feasibility and acceptability of implementing a transdiagnostic cognitive behavioral therapy for children impacted by trauma within a residential treatment facility. Child & Youth Services, 46(2), 299-324.'}, {'pmid': '27771133', 'type': 'BACKGROUND', 'citation': 'Ehrenreich-May J, Rosenfield D, Queen AH, Kennedy SM, Remmes CS, Barlow DH. An initial waitlist-controlled trial of the unified protocol for the treatment of emotional disorders in adolescents. J Anxiety Disord. 2017 Mar;46:46-55. doi: 10.1016/j.janxdis.2016.10.006. Epub 2016 Oct 17.'}, {'type': 'BACKGROUND', 'citation': 'Habib, M., Labruna, V., & Newman, J. (2013). Complex histories and complex presentations: Implementation of a manually-guided group treatment for traumatized adolescents. Journal of family violence, 28(7), 717-728.'}, {'type': 'BACKGROUND', 'citation': 'National Child Traumatic Stress Network. (2025). Structured psychotherapy for adolescents responding to chronic stress (SPARCS). https://www.nctsn.org/sites/default/files/interventions/structured-psychotherapy-for-adolescent-responding-to-chronic-stress-2025.pdf'}]}, 'descriptionModule': {'briefSummary': "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", 'detailedDescription': "The Supporting Purposeful Interventions \\& Resilience in Trauma (SPIRIT) program at Ann \\& Robert H. Lurie Children's Hospital of Chicago provides trauma-informed, evidence-based care for youth ages 8-18 with chronic medical conditions and psychological trauma exposure who are experiencing trauma-related distress. Youth with chronic medical conditions are at increased risk for psychological stress due to frequent medical procedures, hospitalizations, and disease-related challenges, alongside prior family or community adversity. The SPIRIT program integrates behavioral health services into routine clinical care, using structured interventions to address trauma, improve coping, and support daily functioning.\n\nThis clinical trial uses a Sequential, Multiple Assignment, Randomized Trial (SMART) design to evaluate two cognitive-behavioral therapies: Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS) and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP). The SMART design allows researchers to compare the effectiveness of each therapy delivered in isolation and in sequence, providing data on which approach or combination of approaches is most effective for youth who respond differently to initial group treatment.\n\nParticipants first complete screening and baseline assessments within the SPIRIT program, which includes standardized measures of trauma-related symptoms, emotional distress, and daily functioning. Youth are then randomly assigned to receive group therapy using either SPARCS or UP. Group therapy sessions are delivered in alignment with routine clinical procedures and follow manualized protocols specific to each intervention. Youth who do not demonstrate sufficient improvement after group therapy are re-randomized to receive additional individual therapy using either SPARCS or UP. This stepwise approach allows the study to evaluate the effectiveness of both therapies in isolation, as well as the optimal sequence of group followed by individual therapy.\n\nData collection is embedded within clinical care and occurs at multiple time points: enrollment/baseline, and every 12 weeks through 48 weeks. All participants are followed for up to 48 weeks to evaluate longitudinal changes in trauma symptoms, emotional well-being, and daily functioning. Data collection includes structured surveys, clinician ratings, and retrospective chart review conducted as part of program evaluation.\n\nThe SPIRIT SMART trial also allows for exploratory analyses of factors that may moderate treatment response, such as individual characteristics, medical complexity, and baseline symptom profiles. Findings from this study will provide valuable guidance for optimizing trauma-focused interventions within pediatric medical settings and support broader dissemination of effective practices for youth facing both medical and psychological challenges."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '8 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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/legal guardian are willing and able to provide informed consent/assent for randomization.\n* Youth and parent/legal guardian are fluent in English or Spanish.\n* Youth is not currently engaged in individual therapy at the time of enrollment (per patient/parent 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.'}, 'identificationModule': {'nctId': 'NCT07483333', 'briefTitle': 'Comparative Effectiveness of SPARCS and Unified Protocol for Youth With Chronic Medical Conditions and Trauma-Related Distress', 'organization': {'class': 'OTHER', 'fullName': "Ann & Robert H Lurie Children's Hospital of Chicago"}, 'officialTitle': 'Supporting Purposeful Interventions & Resilience In Trauma (SPIRIT) Program: Implementing Trauma-Specific Screening and Stratified Interventions for Youth With a Chronic Medical Condition', 'orgStudyIdInfo': {'id': '2025-7413'}, 'secondaryIdInfos': [{'id': 'H79SM087908', 'type': 'OTHER_GRANT', 'domain': 'Substance Abuse and Mental Health Services Administration (SAMHSA)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SPARCS Group Therapy [Stage 1 Randomization]', 'description': '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).', 'interventionNames': ['Behavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group']}, {'type': 'EXPERIMENTAL', 'label': 'Unified Protocol Group Therapy [Stage 1 Randomization]', 'description': '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).', 'interventionNames': ['Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group']}, {'type': 'EXPERIMENTAL', 'label': 'SPARCS Individual Therapy for Non-Responders [Stage 2 Randomization]', 'description': '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.', 'interventionNames': ['Behavioral: Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual']}, {'type': 'EXPERIMENTAL', 'label': 'UP Individual Therapy for Non-Responders [Stage 2 Randomization]', 'description': '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.', 'interventionNames': ['Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual']}], 'interventions': [{'name': 'Structured Psychotherapy for Adolescents Responding to Chronic Stress - Group', 'type': 'BEHAVIORAL', 'otherNames': ['SPARCS'], 'description': '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.', 'armGroupLabels': ['SPARCS Group Therapy [Stage 1 Randomization]']}, {'name': 'Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Group', 'type': 'BEHAVIORAL', 'otherNames': ['UP', 'Unified Protocol'], 'description': '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.', 'armGroupLabels': ['Unified Protocol Group Therapy [Stage 1 Randomization]']}, {'name': 'Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents - Individual', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['UP Individual Therapy for Non-Responders [Stage 2 Randomization]']}, {'name': 'Structured Psychotherapy for Adolescents Responding to Chronic Stress - Individual', 'type': 'BEHAVIORAL', 'otherNames': ['SPARCS'], 'description': "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.", 'armGroupLabels': ['SPARCS Individual Therapy for Non-Responders [Stage 2 Randomization]']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'contacts': [{'name': 'Anthony T. Vesco, PhD', 'role': 'CONTACT', 'email': 'avesco@luriechildrens.org', 'phone': '312-227-5075'}], 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Anthony T. Vesco, PhD', 'role': 'CONTACT', 'email': 'avesco@luriechildrens.org', 'phone': '312-227-5075'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'ipdSharing': 'YES', 'description': "Deidentified individual participant data that underlie the study results, along with a data dictionary, will be made available upon reasonable request. Requests should be directed to the principal investigator for review. Data will be shared with researchers who provide a methodologically sound proposal for use in achieving the aims of the approved proposal. The study team will review requests with the IRB and other relevant data management collaborators at Lurie Children's to obtain institutional approvals and guarantee legal and ethical research and HIPAA compliance. To gain access, data requestors will need to sign a data access and use agreement."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anthony Vesco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Substance Abuse and Mental Health Services Administration (SAMHSA)', 'class': 'FED'}, {'name': 'Northwestern University Feinberg School of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry and Behavioral Sciences (Child and Adolescent Psychiatry)', 'investigatorFullName': 'Anthony Vesco', 'investigatorAffiliation': "Ann & Robert H Lurie Children's Hospital of Chicago"}}}}