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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
Written Exposure Therapy (WET) is an evidence-based treatment (EBT) for PTSD among adults that involves five 45-60 minute sessions. WET is non-inferior to gold-standard EBTs for PTSD among adults, including Cognitive Processing Therapy and Prolonged Exposure. Each session involves 30-minutes writing following focused prompts that include recalling details of the traumatic event as well as related cognitions and emotions. Session one also includes providing psychoeducation about posttraumatic stress disorder and the rationale for exposure. Between sessions, the therapist reads the writing and prepares feedback. The intervention will be delivered during five, consecutive weekly 45-60-minute sessions to participants assigned to the experimental WET condition.
Trauma-focused cognitive behavior therapy (TF-CBT) is the gold-standard EBT for adolescents with PTSD and is comprised of three phases: safety and stabilization, gradual exposure, and consolidation/integration. The safety and stabilization phase includes psychoeducation, parenting skills training, and building coping skills. The gradual exposure phase involves helping the youth describe a detailed narrative of the traumatic event(s) and craft an in vivo hierarchy of trauma-related feared, but objectively safe, stimuli to face in a gradual fashion. During the final consolidation/integration phase, a conjoint caregiver-child session in which the child shares their trauma narrative with a caregiver occurs and youth are taught skills and education to enhance future safety. Youth randomized to TF-CBT will receive 12-16 consecutive 60-minute weekly sessions following the manual.
Medical University of South Carolina National Crime Victims Research and Treatment Center
Charleston, South Carolina, United States
Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS; Adolescents Only)
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.
Time frame: Baseline through study completion, an average of 6 months.
Child and Adolescent Trauma Screen 2.0 - Caregiver and Child Report
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.
Time frame: Baseline through study completion, an average of 6 months.
Cognitive Emotion Regulation Questionnaire-Adolescent Version
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).
Time frame: Baseline through study completion, an average of 6 months.
Acceptability of Intervention Measure (Youth and Caregivers)
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).
Time frame: 6 weeks post-baseline and through study completion, an average of 6 months.
Feasibility of Intervention Measure (Youth and Caregivers)
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).
Time frame: 6 weeks post-baseline and through study completion, an average of 6 months.
Intervention Appropriateness Measure (Youth and Caregivers)
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).
Time frame: 6 weeks post-baseline and through study completion, an average of 6 months.
Semi-Structured Interview (Adolescents 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.
Time frame: 6 week follow up (WET condition only)
Revised Children's Anxiety and Depression Scale - Caregiver and Child Report
Revised Children's Anxiety and Depression Scale caregiver and child surveys are 25-item scales assessing for depression and anxiety symptoms among youth. The full subscales from the RCADS-47 for social phobia and obsessive compulsive disorder symptoms will also be administered to youth. The RCADS-25 is psychometrically strong scales for use with adolescents and caregivers and therefore will be used to assess participant self-reported symptoms of depression and anxiety. Scores range from 0 to 75 and raw scores are converted to T scores in relation to normed data based on same aged peers. Higher scores on this measure indicate greater levels of depression and anxiety.
Time frame: 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)
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. Screeners and, full modules when indicated following screens, will be used to facilitate accurate screening and diagnosis of comorbidities to identify whether participants meet inclusion or exclusion criteria at baseline (i.e., active psychosis, active suicidal plan and intent, anorexia nervosa, severe substance use withdrawal symptoms, active psychosis). This interview has several subscales that allow for a diagnostic interview to assess common psychiatric conditions among youth and does not have a standardized range of scores. The Mania, schizophrenia, eating disorder, and suicide screeners and full modules when screeners are positive will be used.
Time frame: Baseline through study completion, an average of 6 months.
Mental Health Statistics Improvement Program (MHSIP) Youth Survey (Caregiver and Youth Report)
The Mental Health Statistics Improvement Program (MHSIP) Youth Survey is a standardized tool to assess youth and caregiver's perceptions of mental health services they received including treatment satisfaction and appropriateness of the intervention to meet one's mental health needs. It has been used among adolescent and caregiver populations and has strong psychometric properties. Total scores on this measure range from 25 to 125. Higher scores indicate greater satisfaction with the intervention (either Written Exposure Therapy or Trauma-focused Cognitive Behavior Therapy).
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Time frame: 6 weeks post-baseline and through study completion, an average of 6 months.
Therapeutic Alliance Scale for Children (TASC) - Revised (Caregiver and Child Report)
The Therapeutic Alliance Scale for Children (TASC) - Revised is a 12 item measure designed to assess therapeutic alliance between therapists and patients as perceived by the patient and by their caregiver. This will be administered during the follow up phase to assess perceptions of the therapeutic alliance. Total scores on this measure range from 12 to 48. Higher scores indicate greater levels of therapeutic alliance.
Time frame: 6 weeks post-baseline and through study completion, an average of 6 months.
Prolonged Grief Scale - 13 (Adolescents Only)
Youth who endorse traumatic loss will complete the thirteen item Prolonged Grief Scale to assess for symptoms of traumatic grief. Total scores on this measure range from 11 to 55; scores of 30 or higher indicate elevated symptoms of prolonged grief. Higher scores indicate higher levels of prolonged grief disorder symptoms.
Time frame: 6 weeks post-baseline and through study completion, an average of 6 months.
Rosenberg Self Esteem Scale
The Rosenberg Self Esteem Scale is comprised of 10 items assessing self esteem among youth. Responses range from 0 to 30 and lower scores indicate lower levels of self esteem.
Time frame: Baseline through study completion, an average of 6 months.
Multidimensional Scale of Perceived Social Support
The Multidimensional Scale of Perceived Social Support will be administered to youth and their caregivers to assess perceptions of their current social support. This twelve item scale has a potential score range of 12 to 84; higher scores indicate higher levels of perceived social support.
Time frame: Baseline through study completion, an average of 6 months.
Posttraumatic Stress Disorder Checklist - 8 (Caregiver Only)
The Posttraumatic Stress Disorder (PTSD) Checklist - 8 will be used to assess caregiver symptoms of PTSD. Total range of potential scores is from 8 to 32 and higher scores indicate greater PTSD symptomatology among caregivers. Scores over 12 indicate likelihood of PTSD symptoms.
Time frame: Baseline, 6-, 10-, 20-, 30-week follow up
Alabama Parenting Questionnaire (Caregivers only)
The Alabama Parenting Questionnaire, nine item short form, will be used to assess parenting approaches and strategies among caregivers who participate in the trial over the course of the study. Three subscales are assessed in the measure: Positive parenting (possible score range: 6-30), inconsistent discipline (possible score range: 6-30), and poor supervision (possible score range: 9-45). Higher scores on each subscale indicate greater levels of each of the subscale categories assessed.
Time frame: Baseline through study completion, an average of 6 months.
Parental Self Efficacy Scale (caregivers only)
The Parental Self Efficacy Scale 5 item measure will be used to assess Parental Self Efficacy among caregivers who participate in the study. Total score responses range from 5 to 25 and higher scores indicate higher levels of perceived self efficacy as a parent.
Time frame: Baseline through study completion, an average of 6 months.
DSM-5-TR Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure (Caregiver Report)
The DSM-5-TR Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure is a 25 item measure will be used to assess caregiver perceptions of their child mental health with regard to several domains (Depression, Anger and Irritability, Mania, Anxiety, Somatic symptoms, Inattention, Suicidal ideation/attempt, Psychosis, Sleep disturbance, Repetitive thoughts and behaviors, and Substance use). The measure will be administered to assess caregiver perceptions of these symptoms among youth as perceived by caregivers over the course of the study as well as will be used at baseline to screen for the presence of potential comorbid symptoms that could indicate a need to further assess for potential exclusion criteria
Time frame: Baseline through study completion, an average of 6 months.