[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654235":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":11,"studyPopulation":11,"armGroups":68,"interventions":74,"overallOfficials":79,"centralContacts":83,"locations":92,"responsibleParty":110,"collaborators":114,"id":118,"slug":119,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":11,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":11,"studyType":131,"phases":132,"briefSummary":133,"conditions":134,"keywords":136,"overallStatus":140,"whyStopped":11,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":150},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":40,"otherOutcomes":11},[9,13,16,19,21,24,28,31,34,36],{"measure":10,"description":11,"timeFrame":12},"Feasibility as assessed by the number of participants recruited",null,"From baseline to end of study (30 weeks form baseline)",{"measure":14,"description":11,"timeFrame":15},"Feasibility as assessed by the number of participants enrolled in the study","end of study (30 weeks form baseline)",{"measure":17,"description":18,"timeFrame":15},"Feasibility as assessed by the number of participants retained in the study","Retained is described as participants who enroll in the study and remain enrolled through the study endpoint\u002Ffinal.",{"measure":20,"description":11,"timeFrame":12},"Feasibility as assessed by the proportion of scheduled intervention sessions attended by each participant",{"measure":22,"description":11,"timeFrame":23},"Feasibility as assessed by number of participants that completed the intervention","end of study (30 weeks from baseline)",{"measure":25,"description":26,"timeFrame":27},"Change in acceptability by youth as assessed by participant satisfaction questionnaires","Satisfaction will be assessed using a 10-item questionnaire. Participants will respond to each item with either \"Agree\" or \"Disagree.\" The total number of \"Agree\" responses will be calculated, resulting in a total score ranging from 0 to 10. A higher number of \"Agree\" responses indicates greater satisfaction.","6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)",{"measure":29,"description":30,"timeFrame":27},"Change in acceptability by caregiver as assessed by participant satisfaction questionnaires","This is a 13 item questionnaire and each is scored from 1(very dissatisfied) to 7 (Very satisfied) for a score range of 13-91, higher scores indicating better outcome",{"measure":32,"description":33,"timeFrame":27},"Change in acceptability of the intervention by the youth as assessed by qualitative exit interviews","This is a 11 item questionnaire and each is scored from 1 (Strongly disagree) to 5 (Strongly agree) for a maximum score range of 11-55, higher scores indicating better outcome",{"measure":35,"description":33,"timeFrame":27},"Change in acceptability of the intervention by the caregiver as assessed by qualitative exit interviews",{"measure":37,"description":38,"timeFrame":39},"Child traumatic stress symptoms as assessed by the Child Trauma Screen (CTS)","This is a 10 item questionnaire divided into 2 components:\n\nFour items assess exposure to potentially traumatic events using a yes\u002Fno response format, and six items assess PTSD-related reactions using a 4-point response scale scored from 0 to 3. The six reaction items are summed to produce a Reactions Total score ranging from 0 to 18, with higher scores indicating greater traumatic stress symptom severity. A Reactions Total score of ≥6 indicates a high likelihood of clinically significant PTSD symptoms","Baseline, 6 weeks after baseline (Step 2), 6-12 weeks after Step 2 (Step 3), 6-12 weeks after Step 3 (Step 4)",[41,44,46,48,50,53,56,59],{"measure":42,"description":43,"timeFrame":39},"Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS)(child's self-report)","This is a 47 item questionnaire and each is scored from 0 (Never) to 3 (Always) for a maximum score range of 0-141, with higher scores indicating greater severity of anxiety and depressive symptoms",{"measure":45,"description":43,"timeFrame":39},"Change in youth anxiety symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS), (parent report )",{"measure":47,"description":43,"timeFrame":39},"Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (child's self-report)",{"measure":49,"description":43,"timeFrame":39},"Change in youth depressive symptoms as assessed by the Revised Children's Anxiety and Depression Scale (RCADS) (parent report)",{"measure":51,"description":52,"timeFrame":39},"Change in emotional and behavioral problems as assessed by the Pediatric Symptom Checklist-17 (PSC-17)","The Pediatric Symptom Checklist-17 (PSC-17) is a 17-item screening measure of psychosocial, emotional, and behavioral problems in children and adolescents. Each item is rated on a 3-point scale from 0 (Never) to 2 (Often). Item scores are summed to generate a Total Problems Score, ranging from 0 to 34, with higher scores indicating greater emotional and behavioral difficulties.",{"measure":54,"description":55,"timeFrame":27},"Intervention Appropriateness as assessed by the Intervention Appropriateness Measure (IAM)","This is a 4-item implementation outcome measure rated on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). Scores will be calculated by averaging item responses , with higher scores indicating greater perceived appropriateness.",{"measure":57,"description":58,"timeFrame":27},"Change in acceptability as assessed by the Acceptability of Intervention Measure (AIM)","This is a 4 item questionnaire and each is scored on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree). The four item scores are averaged to generate an overall AIM score ranging from 1 to 5, with higher scores indicating greater perceived acceptability of the intervention.",{"measure":60,"description":61,"timeFrame":27},"Feasibility as assessed by the Feasibility of Intervention Measure (FIM).","This is a 4 item questionnaire and each is scored on a 5-point Likert scale ranging from 1 (Completely disagree) to 5 (Completely agree) for a maximum score range of 1-20,with higher scores indicating greater perceived feasibility of the intervention.",{"allocation":63,"interventionModel":64,"interventionModelDescription":11,"primaryPurpose":65,"observationalModel":11,"timePerspective":11,"maskingInfo":66},"NA","SINGLE_GROUP","PREVENTION",{"masking":67,"maskingDescription":11,"whoMasked":11},"NONE",[69],{"label":70,"type":71,"description":11,"interventionNames":72},"PSC-TF-CBT","EXPERIMENTAL",[73],"Behavioral: PSC-TF-CBT",[75],{"type":76,"name":70,"description":77,"armGroupLabels":78,"otherNames":11},"BEHAVIORAL","The intervention is a stepped-care adaptation of Trauma-Focused Cognitive Behavioral Therapy (PSC-TF-CBT) delivered within pediatric primary care. Treatment intensity is matched to each participant's individual clinical needs, with participants receiving lower-intensity intervention components initially and progressing to more intensive trauma-focused treatment as clinically indicated. PSC-TF-CBT incorporates trauma-focused cognitive behavioral therapy strategies for youth and includes caregiver involvement.",[70],[80],{"name":81,"affiliation":5,"role":82},"Funlola G Are","STUDY_DIRECTOR",[84,89],{"name":85,"role":86,"phone":87,"phoneExt":11,"email":88},"Funlola G Are, PhD","CONTACT","(713) 486-2700","Funlola.G.Are@uth.tmc.edu",{"name":90,"role":86,"phone":11,"phoneExt":11,"email":91},"Kofoworola Bombata","Kofoworola.Bombata@uth.tmc.edu",[93],{"facility":94,"status":11,"city":95,"state":96,"zip":97,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":105,"contacts":106},"The University of Texas Health science Center at Houston","Houston","Texas","77030","United States","US",{"type":101,"coordinates":102},"Point",[103,104],-95.36327,29.76328,{"lat":104,"lon":103},[107,109],{"name":85,"role":86,"phone":108,"phoneExt":11,"email":88},"713-486-2700",{"name":90,"role":86,"phone":11,"phoneExt":11,"email":91},{"type":111,"investigatorFullName":112,"investigatorTitle":113,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Funlola Are","Assistant Professor",[115],{"name":116,"class":117},"The Texas Child Mental Health Care Consortium (TCMHCC)","UNKNOWN","100654235","using-a-primary-care--based-stepped-care-model-of-trauma-focused-cognitive-behavioral-therapy-psc-tf-cbtto-reduce-trauma-symptoms-and-negative-mental-health-sequelae-100654235",false,"NCT07797400","Using a Primary Care- Based Stepped-Care Model of Trauma Focused Cognitive Behavioral Therapy (PSC-TF-CBT)to Reduce Trauma Symptoms and Negative Mental Health Sequelae","Using a Primary Care- Based Stepped-Care Model of Trauma Focused Cognitive Behavioral Therapy to Reduce Trauma Symptoms and Negative Mental Health Sequelae","Inclusion Criteria:\n\n* able to read or understand English\n\nExclusion Criteria:\n\n* Currently receiving mental health treatment elsewhere\n* Clinical exclusion criteria:\n\n  1. Evidence of active suicidality\n  2. Presence of psychotic symptoms\n\nSevere psychiatric or posttraumatic symptom impairment requiring immediate mental health treatment or hospitalization, defined as:\n\n1. Score ≥ 40 on the child-report measure, or\n2. Score ≥ 42 on the caregiver-report measure -Cognitive or comprehension difficulties that would prevent the child or caregiver from completing study assessments","ALL","8 Years","14 Years",{"count":129,"type":130},30,"ESTIMATED","INTERVENTIONAL",[63],"The purpose of this study is to evaluating the feasibility of delivering a trauma-focused intervention among children with elevated traumatic stress symptoms in primary care",[135],"Trauma Patients",[137,138,139],"Cognitive Behavioral Therapy","Trauma","pediatric primary care","NOT_YET_RECRUITING","2026-08-27",{"date":143,"type":144},"2026-09-01","ACTUAL",{"date":146,"type":130},"2026-08-31",{"date":148,"type":130},"2027-08-01",{"name":5,"class":6},1]