Adapting Written Exposure Therapy for Adolescents With Posttraumatic Stress Disorder
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS; Adolescents Only)
研究概览
简要总结
Written Exposure Therapy (WET) is a five-session mental health therapy for posttraumatic stress disorder (PTSD). Research shows that it works as well as longer treatments for PTSD among people over 18, even though it requires fewer sessions than other PTSD therapies. However, WET has not been adapted and formally tested in individual therapy with people aged 12 to 18. The present study aims to see how WET can be adapted to meet the needs of people aged 12 to 18 who have experienced trauma and currently have PTSD symptoms. To adapt WET for this age group, interviews will be conducted with PTSD experts and people aged 12 to 18 to learn what changes would help to make WET more suitable for young people. Next, WET will be delivered to five people aged 12 to 18 (using the WET manual as it is written for people over the age of 18) to obtain feedback about what changes should be made to better meet the needs of this age group.
In the next part of the study, 48 adolescents aged 12 to 18 who have symptoms of PTSD will be recruited from an integrated pediatric primary clinic (PPC). Youth and caregivers who agree to participate will be randomized (like the flip of a coin) to either receive the adapted version of WET or to receive our current, gold-standard PTSD treatment: Trauma-Focused Cognitive Behavior Therapy (TF-CBT). Participants assigned to receive adapted WET will take part in five to seven weekly therapy sessions. Participants assigned to receive TF-CBT will take part in 12 to 16 weekly therapy sessions. Participants assigned to both groups will complete five study visits: one before therapy and four follow up assessments at 6-weeks, 10-weeks, 20-weeks, and 30-weeks after starting therapy. The purpose of the study visits occurring over a 30-week time period is to better understand how mental health symptoms and diagnoses may change over time following therapy engagement. All therapy and study visits can be completed remotely or in person, per the participant's preference. Individuals who are 18 can participate without caregiver permission; individuals aged 12 to 17 can only participate with caregiver permission. Ultimately, it is hoped that the results of the study will help inform efforts to increase access to treatment for posttraumatic stress disorder among young people.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aim 1 (Obj. 1.1) Inclusion Criteria for Adolescents with PTSD:
- •Between the ages of 12 through 18 years old. 18-year-old participants who turn 18 after the date in which they consent to participate may participate, but may not enroll in the study if already at the age of
- •Accompanying, consenting caregiver (exception, 18-year-olds can provide consent without accompanying caregiver)
- •Exposure to one or more potentially traumatic event(s) on the NCVTRC clinic phone screen.
- •Ability to comprehend English.
- •A score of greater than or equal to 6 on the Child Trauma Screen (CTS)
- •Residence in the state of South Carolina.
- •Aim 1 (Obj. 1.1)
排除标准
- •for Adolescents with PTSD:
- •Active psychosis, bipolar disorder, or a comorbid condition that requires a higher level of immediate care (e.g., anorexia nervosa, alcohol withdrawal).
- •Active suicide risk with ideation, plan and intent.
- •Active, ongoing violence, abuse, or other ongoing traumatic events that indicate immediate safety concerns.
- •Children in foster care, kinship care, or with active Department of Social Services (DSS) investigations.
- •History of pervasive developmental or intellectual disability.
- •Any other medical or psychiatric condition that compromise the participant's ability to safely participate.
- •Inability or unwillingness of the caregiver to consent for adolescent to participate (exception, 18-year-olds can provide consent without accompanying caregiver).
- •Aim 1 (Obj. 1.1) Inclusion Criteria for PTSD Treatment Providers:
- •Masters-level degree or higher in psychology or a related discipline (e.g., social work; counseling).
- •Current provider of trauma-focused treatment to adolescents with PTSD in an outpatient setting for a minimum of one year.
- •Ability to comprehend English.
- •Consent to participate in a one time study visit.
- •Aim 1 (Obj 1.1) Inclusion Criteria for Pediatric Primary Care Mental Health Providers:
- •Masters-level degree or higher in psychology or a related discipline (e.g., social work; counseling).
- •Current status as a mental health clinician housed in an integrated pediatric primary care setting.
- •Ability to comprehend English.
- •Consent to participate in a one-time study visit.
- •There are no exclusion criteria for Aim 1 Providers.
- •Aim 1 (Obj 1.2 theater testing) and Aim 2 (RCT) Inclusion Criteria for Adolescents with PTSD:
- •Adolescent between the ages of 12 through 18 years old. 18-year-old participants who turn 18 after the date in which they consent to participate may participate, but may not enroll in the study if already at the age of
- •Accompanying consenting caregiver (exception, 18-year-olds can provide consent without accompanying caregiver)
- •Endorsement of one or more exposure to past potentially traumatic event(s). Trauma event(s) must have occurred over one-month ago, per DSM-5 criteria.
- •Ability to comprehend English.
- •A score of greater than or equal to 21 on the Child and Adolescent Trauma Screen (CATS).
- •Residence in the state of South Carolina.
- •Aim 1 (Obj 1.2 theater testing) and Aim 2 (RCT) Exclusion Criteria for Adolescents with PTSD:
- •Active psychosis, bipolar disorder, or a comorbid condition that requires a higher level of immediate care (e.g., anorexia nervosa, alcohol withdrawal).
- •Active suicide risk with ideation, plan and intent.
- •Active, ongoing violence, abuse, or other ongoing traumatic events that indicate immediate safety concerns.
- •Children in foster care, kinship care, or with active DSS investigations.
- •History of pervasive developmental or intellectual disability.
- •Any other medical or psychiatric condition that compromise the participant's ability to safely participate.
- •Inability or unwillingness of caregiver to consent for adolescent to participate (exception, 18-year-olds can participate without an accompanying caregiver).
- •Lack of any memory of the traumatic event(s).
- •Individuals psychotropic medications must be stabilized on the medication for at least two weeks prior to study start date.
- •Recruitment will not include special classes of subjects such as prisoners, pregnant women, or institutional individuals.
研究组 & 干预措施
Experimental Group (Written Exposure Therapy)
干预措施: Written Exposure Therapy (Behavioral)
Comparison Condition (Trauma-focused Cognitive Behavior Therapy)
干预措施: Trauma-focused Cognitive Behavior Therapy (Behavioral)
结局指标
主要结局
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS; Adolescents Only)
时间窗: Baseline through study completion, an average of 6 months.
The Kiddie Schedule for Affective Disorders and Schizophrenia, which is a psychometrically strong tool to assess diagnoses for a wide variety of mental health conditions among adolescents, will be used to assess Posttraumatic Stress Disorder (PTSD) symptoms present and diagnostic criteria over the course of the longitudinal period. Higher scores indicate greater likelihood of meeting diagnostic criteria for PTSD.
Child and Adolescent Trauma Screen 2.0 - Caregiver and Child Report
时间窗: Baseline through study completion, an average of 6 months.
The Child and Adolescent Trauma Screen (CATS) youth and caregiver reports (ages 7-17) assess exposure to 15 different types of potentially traumatic events followed by 20-items assessing PTSD symptoms. It is a widely used psychometrically validated tool and will be used to assess the adolescent's trauma exposure history and PTSD symptoms per self and caregiver report. Total scores on this measure range from 0 to 60; scores of 21 or higher indicate elevated symptoms of posttraumatic stress disorder (PTSD). Higher scores indicate greater PTSD symptom severity.
Cognitive Emotion Regulation Questionnaire-Adolescent Version
时间窗: Baseline through study completion, an average of 6 months.
The Cognitive Emotion Regulation Questionnaire - Adolescent Version is a 36 item psychometrically strong measure of cognitive and emotion regulation strategies and has been used widely with trauma-exposed adolescents. The rumination subscale of the CERQ will be used to examine changes in ruminative thinking, a proposed mechanism of WET's action to be tested in the study, over the course of treatment. Total scores on this measure range from 36 to 180. Several subscales are included on this measure: Self-blame, Other-blame, Rumination, Catastrophizing, Putting into perspective, Positive refocusing, Positive reappraisal, Acceptance, and Planning. Higher scores indicate higher levels of experiencing each symptom area measured (e.g., higher scores on the self blame subscale indicate greater self-blame; higher scales on the positive re-focusing indicate greater ability to positively refocus).
Acceptability of Intervention Measure (Youth and Caregivers)
时间窗: 6 weeks post-baseline and through study completion, an average of 6 months.
The Acceptability of Intervention Measure is a 4-item measure used to assess patient perceptions of new interventions, including whether they believe the new treatment is agreeable, palatable, or satisfactory on a five-point Likert scale. This measure will be administered to adolescents and their caregivers to gauge acceptability of the experimental intervention for meeting the needs of the adolescent population. Scores are averaged; total scores on this measure range from 1 to 5. Higher scores indicate greater acceptability of the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).
Feasibility of Intervention Measure (Youth and Caregivers)
时间窗: 6 weeks post-baseline and through study completion, an average of 6 months.
The Feasibility of Intervention Measure is a 4-item measure to assess perceptions of whether an intervention will be able to be successfully implemented within a given agency or setting to a certain population of interest. This measure will be administered to adolescents and caregivers to gauge perceptions of feasibility of WET for delivery with adolescents. Scores are averaged; total scores on this measure range from 1 to 5. Higher scores indicate greater perceived feasibility of the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).
Intervention Appropriateness Measure (Youth and Caregivers)
时间窗: 6 weeks post-baseline and through study completion, an average of 6 months.
The Intervention Appropriateness Measure is a 4-item measure to assess perceptions of whether an intervention is perceived as appropriate for addressing the needs/symptoms of a population. This measure will be administered to adolescents and caregivers to gauge perceptions of the appropriateness of WET delivered to 12 to 18 year olds. Scores are averaged; total scores on this measure range from 1 to 5. Higher scores indicate greater perceived feasibility of the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).
Semi-Structured Interview (Adolescents Only)
时间窗: 6 week follow up (WET condition only)
Questions will include probes about how to enhance the intervention to elicit impressions of the un-adapted content (e.g., written prompt wording, relevance of psychoeducational content, helpfulness), areas in need of adaptation, gaps missing in the manual, and recommendations for adaptations (e.g., wording alterations, content adaptations). Interviews will also inquire about barriers and facilitators to traditional trauma-focused treatment and whether WET meets or does not meet priorities and needs of adolescents with PTSD and their caregivers.
University of California- Los Angeles Posttraumatic Stress Disorder Reaction Index
时间窗: Baseline, 6-, 10-, 20-, and 30-week follow up.
The University of California- Los Angeles Posttraumatic Stress Disorder Reaction Index (adolescent and caregiver versions), which are psychometrically strong tools to assess PTSD diagnosis among adolescents, will be administered. Total scores on this measure range from 0 to 108; scores of 35 or higher indicate high likelihood that individuals meet posttraumatic stress disorder (PTSD) diagnostic criteria. Higher scores indicate greater likelihood of meeting diagnostic criteria for PTSD.
Child and Adolescent Trauma Screen 2.0
时间窗: Baseline, 6-, 10-, 20-, and 30-week follow up
The Child and Adolescent Trauma Screen (CATS) youth and caregiver reports (ages 7-17) assess exposure to 15 different types of potentially traumatic events followed by 20-items assessing PTSD symptoms. It is a widely used psychometrically validated tool and will be used to assess the adolescent's trauma exposure history and PTSD symptoms per self and caregiver report. Total scores on this measure range from 0 to 60; scores of 21 or higher indicate elevated symptoms of posttraumatic stress disorder (PTSD). Higher scores indicate greater PTSD symptoms.
Cognitive Emotion Regulation Questionnaire- Short (CERQ - Short)
时间窗: Baseline, 6-, 10-, 20-, and 30-week follow up
The Cognitive Emotion Regulation Questionnaire - Short is an 18-item psychometrically validated measure of emotion regulation strategies and has been used widely with trauma exposed adolescents. The rumination subscale of the CERQ will be used to examine changes in ruminative thinking, a proposed mechanism of WET's action to be tested in the study, over the course of treatment. Total scores on this measure range from 18 to 90. Several subscales are included on this measure: Self-blame, Other-blame, Rumination, Catastrophizing, Putting into perspective, Positive refocusing, Positive reappraisal, Acceptance, and Planning Higher scores indicate higher levels of experiencing each symptom area measured (e.g., higher scores on the self blame subscale indicate greater self-blame; higher scales on the positive re-focusing indicate greater ability to positively refocus).
Acceptability of Intervention Measure
时间窗: 6-, 10-, 20-, and 30-week follow up
The Acceptability of Intervention Measure is a 4-item measure used to assess patient perceptions of new interventions, including whether they believe the new treatment is agreeable, palatable, or satisfactory on a five-point Likert scale. This measure will be administered to adolescents and their caregivers to gauge acceptability of the experimental intervention for meeting the needs of the adolescent population. Scores are averaged; total scores on this measure range from 1 to 5. Higher scores indicate greater acceptability of the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).
Feasibility of Intervention Measure
时间窗: 6-, 10-, 20-, and 30-week follow up
The Feasibility of Intervention Measure is a 4-item measure to assess perceptions of whether an intervention will be able to be successfully implemented within a given agency or setting to a certain population of interest. This measure will be administered to adolescents and caregivers to gauge perceptions of feasibility of WET for delivery with adolescents. Scores are averaged; total scores on this measure range from 1 to 5. Higher scores indicate greater perceived feasibility of the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).
Client Satisfaction Questionnaire - 8 item
时间窗: 6-week follow up (WET condition) and 20-week follow up (TF-CBT condition)
The Client Satisfaction Questionnaire (8 item) measure examines satisfaction with treatment services on an 8-item Likert scale to assess perceptions of satisfaction following treatment services. It has been used among adolescent and caregiver populations and has strong psychometric properties. Total scores on this measure range from 8 to 32. Higher scores indicate greater satisfaction with the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).
Subjective Units of Distress
时间窗: Weekly Sessions
As part of WET, Subjective Units of Distress (SUDS) are verbally reported to examine current emotional arousal in response to exposure. Participants are prompted by the therapist to indicate level of emotional arousal on a scale of 0-100 before and following writing. Higher scores indicate greater levels of distress. Therapists will document reported SUDS weekly.
Semi-Structured Interview
时间窗: 6 week follow up (WET condition only)
Questions will include probes about how to enhance the intervention to elicit impressions of the un-adapted content (e.g., written prompt wording, relevance of psychoeducational content, helpfulness), areas in need of adaptation, gaps missing in the manual, and recommendations for adaptations (e.g., wording alterations, content adaptations). Interviews will also inquire about barriers and facilitators to traditional trauma-focused treatment and whether WET meets or does not meet priorities and needs of adolescents with PTSD and their caregivers.
次要结局
- Revised Children's Anxiety and Depression Scale - Caregiver and Child Report(Baseline through study completion, an average of 6 months.)
- The Kiddie Schedule for Affective Disorders and Schizophrenia (Select Screeners and Full Modules: Schizophrenia, Mania, Eating Disorder, Suicidal Ideation; Adolescents Only)(Baseline through study completion, an average of 6 months.)
- Mental Health Statistics Improvement Program (MHSIP) Youth Survey (Caregiver and Youth Report)(6 weeks post-baseline and through study completion, an average of 6 months.)
- Therapeutic Alliance Scale for Children (TASC) - Revised (Caregiver and Child Report)(6 weeks post-baseline and through study completion, an average of 6 months.)
- Prolonged Grief Scale - 13 (Adolescents Only)(6 weeks post-baseline and through study completion, an average of 6 months.)
- Rosenberg Self Esteem Scale(Baseline through study completion, an average of 6 months.)
- Multidimensional Scale of Perceived Social Support(Baseline through study completion, an average of 6 months.)
- Posttraumatic Stress Disorder Checklist - 8 (Caregiver Only)(Baseline, 6-, 10-, 20-, 30-week follow up)
- Alabama Parenting Questionnaire (Caregivers only)(Baseline through study completion, an average of 6 months.)
- Parental Self Efficacy Scale (caregivers only)(Baseline through study completion, an average of 6 months.)
- DSM-5-TR Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure (Caregiver Report)(Baseline through study completion, an average of 6 months.)
- Mini-International Neuropsychiatric Interview for Children and Adolescents(Baseline, 6-, 10-, 20-, and 30-week follow up)
- Revised Children's Anxiety and Depression Scale(Baseline, 6-, 10-, 20-, and 30-week follow up)
研究者
Emily Tilstra-Ferrell
Research Assistant Professor-Faculty
Medical University of South Carolina