[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07396935":3,"trial-entities:NCT07396935":122,"trial-summary:NCT07396935":127},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":14,"conditions":16,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":33,"secondary_outcomes":43,"sex":72,"minimum_age":73,"maximum_age":74,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":96,"locations":98,"central_contacts":114,"overall_officials":117,"references":120,"see_also_links":121},"NCT07396935","HSC-MS-25-0929 (Pilot)","Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (Pilot)","NOT_YET_RECRUITING","2026-08-31","2026-01","2026-02-09","2026-04-01","The University of Texas Health Science Center, Houston","OTHER",null,"One of the most common and widely disseminated trauma treatments is Trauma Focused Cognitive Behavioral Therapy (TF-CBT). TF-CBT is a therapist-led, structured and sequential intervention, with treatment organized around P.R.A.C.T.I.C.E. (Psychoeducation, Parent training, Relaxation, Affective Regulation, Cognitive Coping, Trauma Narrative, In-Vivo Exposure, Cognitive Reprocessing, and Enhancing Safety) components. Stepped Care Cognitive Behavioral Therapy for Children after Trauma (SC-CBT-CT) is an alternative delivery system that incorporates the best available evidence on the treatment of childhood Post-traumatic Stress Disorder (PTSD) within a stepped care model and utilizes task-shifting with caregiver involvement, which engages caregivers in actively helping their children. Stepped care approaches are characterized by a personalized approach to care in which a lower intensity (i.e., fewer number of sessions) intervention is initially provided before the child is reevaluated or ''stepped up'' for additional care should symptoms persist. The goal of this study is to assess a personalized modification of SC-CBT-CT for Latino families (pSC-CBT-CT). The hypothesis is that personalizing SC-CBT-CT will improve outcomes for Latino children.",[17,18],"Trauma","Posttraumatic Stress Disorder",[],"INTERVENTIONAL","TREATMENT",[23],"NA",{"count":25,"type":26},7,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"BEHAVIORAL","Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT)","The SC-CBT-CT intervention in this study is a data driven, stakeholder-informed revision of SC-CBT-CT that incorporates Latino specific values and beliefs, that is, personalized SC-CBT-CT (pSC-CBT-CT). The intervention consists of two steps utilizing Cognitive Behavioral Therapy (CBT). Step one (Stepping Together for Children after Trauma, SC-CT) involves a caregiver-led, therapist-assisted first step with narrative, imaginal, and exposure therapy, and step two consists of Trauma-Focused Cognitive Behavioral Therapy (TF-CBT), which utilizes gradual exposure. SC-CT includes three therapist-led caregiver-child meetings over 6-9 weeks, with brief weekly phone support (10-15 minutes) from the therapist to caregiver. During 11 home-based, caregiver-led meetings, the child and caregiver work together on therapeutic tasks (i.e., exposure tasks, a trauma narrative, and in-vivo exposure reminders) guided by an empirically supported activity book.",[30],[34,38,40],{"measure":35,"description":36,"timeFrame":37},"Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index (RI) for the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) (UCLA-RI-5) - Child Reported","Total score ranges from 0 to 73, with a higher score indicating worse symptoms.","baseline, week 7, week 15",{"measure":39,"description":36,"timeFrame":37},"Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index for DSM-5 (UCLA-RI-5) - Parent Reported",{"measure":41,"description":42,"timeFrame":37},"Functional Impairment as Assessed by the Columbia Impairment Scale-Parent and Child (CIS-P\u002FC)","Total score ranges from 0 to 65, with a higher score indicating a worse outcome.",[44,47,51,54,57,60,63,66,69],{"measure":45,"description":46,"timeFrame":37},"Number of participants with a PTSD Diagnosis as Assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive disorder (OCD) and Related Neuropsychiatric Disorders Child and Adolescent Version (DIAMOND-KID) Clinical Interview","A PTSD diagnosis using the DIAMOND-KID Clinical Interview is indicated by answering \"yes\" to the presence of 4 types of PTSD symptoms.",{"measure":48,"description":49,"timeFrame":50},"Anxiety as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C\u002FP) - Anxiety Subscore","Total score ranges from 0 to 111, with a higher score indicating greater symptom severity.","baseline, week 15",{"measure":52,"description":53,"timeFrame":50},"Depression as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C\u002FP) - Depression Subscore","Total score ranges from 0 to 30, with a higher score indicating greater symptom severity.",{"measure":55,"description":56,"timeFrame":37},"Clinical Severity of Trauma Symptoms as Assessed by the Clinical Global Impression-Severity\u002FImprovement (CGI-S\u002FI) Scale","Total score ranges from 0 (no illness) to 6 (extremely severe), with a higher score indicating a greater severity of trauma symptoms.",{"measure":58,"description":59,"timeFrame":37},"Clinical Improvement in Trauma Symptoms as Assessed by the Clinical Global Impression Severity\u002FImprovement (CGI-S\u002FI) Scale","Total score ranges from 0 to 7, with a higher score indicating a worse outcome. A score 1, 2 or 3 will be used to indicate treatment response.",{"measure":61,"description":62,"timeFrame":50},"Parent Post-Traumatic Stress Syndrome (PTSS) as Assessed by the PTSD Checklist for DSM-5 (PCL-5)","Total score ranges from 0 to 80, with a higher score indicating a worse outcome.",{"measure":64,"description":65,"timeFrame":50},"Parent Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)","Total score ranges from 0 to 27, with a higher score indicating a worse outcome.",{"measure":67,"description":68,"timeFrame":50},"Parent Anxiety as Assessed by the General Anxiety Disorder-7 (GAD-7) Scale","Total score ranges from 0 to 21, with a higher score indicating a worse outcome.",{"measure":70,"description":71,"timeFrame":50},"Parent Stress as Assessed by the Perceived Stress Scale (PSS)","Scores range from 18 to 90, with a higher score indicating higher parenting stress.","ALL","7 Years","14 Years",true,{"inclusion":77,"exclusion":85,"raw_text":95},[78,79,80,81,82,83,84],"parent and child agree that the target event\u002Findex trauma occurred;","report of at least five symptoms of PTSD (1 from re-experiencing category or 1 from avoidance);","suicidal ideation does not exclude as long as there is no active plan\u002Fintent. Safety planning implemented and continued assessment for plan\u002Fintent;","children ages 7-12 and a legal guardian willing to participate;","can be fluent in English or Spanish;","at least 4 weeks since child's exposure to one or more potentially traumatic events;","trauma exposure occurred after child was 36 months old.",[86,87,88,89,90,91,92,93,94],"Children with pervasive developmental disorders or Autism;","legal guardian or child with active psychosis;","any condition that may limit the legal guardian ability to understand CBT and the child's ability to follow instructions;","children who have unsupervised visitation with their perpetrator;","perpetrator (person that harmed child) is living in the home;","active substance use disorder;","child is currently receiving trauma-focused therapy;","legal guardian is actively suicidal will be excluded from participation;","children who have not been stable on psychotropic medication for 4 or more weeks, and\u002For for benzodiazepines\u002Fstimulants not stable for 2 or more weeks will not be eligible for the trial.","Inclusion Criteria:\n\n* parent and child agree that the target event\u002Findex trauma occurred;\n* report of at least five symptoms of PTSD (1 from re-experiencing category or 1 from avoidance);\n* suicidal ideation does not exclude as long as there is no active plan\u002Fintent. Safety planning implemented and continued assessment for plan\u002Fintent;\n* children ages 7-12 and a legal guardian willing to participate;\n* can be fluent in English or Spanish;\n* at least 4 weeks since child's exposure to one or more potentially traumatic events;\n* trauma exposure occurred after child was 36 months old.\n\nExclusion Criteria:\n\n* Children with pervasive developmental disorders or Autism;\n* legal guardian or child with active psychosis;\n* any condition that may limit the legal guardian ability to understand CBT and the child's ability to follow instructions;\n* children who have unsupervised visitation with their perpetrator;\n* perpetrator (person that harmed child) is living in the home;\n* active substance use disorder;\n* child is currently receiving trauma-focused therapy;\n* legal guardian is actively suicidal will be excluded from participation;\n* children who have not been stable on psychotropic medication for 4 or more weeks, and\u002For for benzodiazepines\u002Fstimulants not stable for 2 or more weeks will not be eligible for the trial.",[97],"CHILD",[99],{"facility":100,"city":101,"state":102,"zip":103,"country":104,"contacts":105,"geoPoint":111},"The University of Texas Health Science Center at Houston","Houston","Texas","77054","United States",[106],{"name":107,"role":108,"phone":109,"email":110},"Leslie K Taylor, PhD","CONTACT","(713) 486-2728","psyc.steppedcarecbt@uth.tmc.edu",{"lat":112,"lon":113},29.76328,-95.36327,[115],{"name":107,"role":108,"phone":116,"email":110},"713-486-2728",[118],{"name":107,"affiliation":12,"role":119},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":123,"biomarkers":126},[124,125],"Injury","Post-Traumatic Stress Disorder",[],{"nct_id":4,"found":75,"summary":128,"prompt_version":136},{"design":129,"status":130,"heading":6,"summary":131,"follow_up":129,"word_count":132,"commitments":133,"compensation":134,"drugs_mentioned":135},"Not specified.","completed","{\n   \"Personalized Stepped Care Cognitive Behavioral Therapy for Trauma in Children\",\n   \"This study is exploring a personalized version of Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) for children aged 7 to 14 who have experienced trauma and are showing symptoms of Post-traumatic Stress Disorder (PTSD). pSC-CBT-CT is a type of talk therapy that helps children and their caregivers learn coping skills. The study aims to see how well this personalized approach helps reduce PTSD symptoms and improve daily functioning. Researchers will measure changes in PTSD severity and how well children are functioning at the start of the study, at 7 weeks, and at 15 weeks, using reports from both children and their parents. This pilot study plans to enroll 7 participants.\",\n  \"design\": \"This is an interventional study, meaning participants will receive a specific treatment. It is a pilot study, planning to enroll 7 participants.\",\n  \"commitments\": \"Participants will have their PTSD symptoms and functional impairment measured at the beginning of the study, at 7 weeks, and at 15 weeks.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"Participants will be followed for 15 weeks after starting the intervention.\",\n}",191,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]