Increasing Treatment Access in Trauma Exposed Children: Developing an Adapted Step One Intervention (RCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •parent and child agree that the target event/index 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/intent. Safety planning implemented and continued assessment for plan/intent;
- •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.
排除标准
- •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/or for benzodiazepines/stimulants not stable for 2 or more weeks will not be eligible for the trial.
研究组 & 干预措施
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.
干预措施: Personalized Stepped Care Cognitive Behavioral Therapy for Children after Trauma (pSC-CBT-CT) (Behavioral)
Treatment as Usual (TAU)
Participants in the TAU condition will be given a list of community resources offering child mental health services for trauma survivors. TAU will likely be Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) or another trauma-informed psychotherapy, which may include similar components.
干预措施: Treatment as Usual (TAU) (Behavioral)
结局指标
主要结局
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
时间窗: baseline, week 7, week 15
Total score ranges from 0 to 73, with a higher score indicating worse symptoms.
Post-Traumatic Stress Severity and Impairment as Assessed by the UCLA PTSD Reaction Index for DSM-5 (UCLA-RI-5) - Parent Reported
时间窗: baseline, week 7, week 15
Total score ranges from 0 to 73, with a higher score indicating worse symptoms.
Functional Impairment as Assessed by the Columbia Impairment Scale-Parent and Child (CIS-P/C)
时间窗: baseline, week 7, week 15
Total score ranges from 0 to 65, with a higher score indicating a worse outcome.
次要结局
- 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(baseline, week 7, week 15)
- Anxiety as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Anxiety Subscore(baseline, week 15)
- Depression as Assessed by the Revised Child Anxiety and Depression Scale (RCADS-C/P) - Depression Subscore(baseline, week 15)
- Clinical Severity of Trauma Symptoms as Assessed by the Clinical Global Impression-Severity/Improvement (CGI-S/I) Scale(baseline, week 7, week 15)
- Clinical Improvement in Trauma Symptoms as Assessed by the Clinical Global Impression Severity/Improvement (CGI-S/I) Scale(baseline, week 7, week 15)
- Parent Post-Traumatic Stress Syndrome (PTSS) as Assessed by the PTSD Checklist for DSM-5 (PCL-5)(baseline, week 15)
- Parent Depression as Assessed by the Patient Health Questionnaire-9 (PHQ-9)(baseline, week 15)
- Parent Anxiety as Assessed by the General Anxiety Disorder-7 (GAD-7) Scale(baseline, week 15)
- Parent Stress as Assessed by the Perceived Stress Scale (PSS)(baseline, week 15)
研究者
Leslie Taylor
Associate Professor
The University of Texas Health Science Center, Houston