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NCT Number: NCT07498257

Examining Written Exposure Therapy Delivered to Adolescents

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.

Active, not recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medical University of South Carolina National Crime Victims Research and Treatment Center

Charleston, South Carolina, 29425, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 19.
  • 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) 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 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 19.
  • 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.

Treatment and study plan

Written Exposure Therapy

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS; Adolescents Only)

    Time frame: 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.

  2. Child and Adolescent Trauma Screen 2.0 - Caregiver and Child Report

    Time frame: 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.

  3. Cognitive Emotion Regulation Questionnaire-Adolescent Version

    Time frame: 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).

  4. Acceptability of Intervention Measure (Youth and Caregivers)

    Time frame: 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).

  5. Feasibility of Intervention Measure (Youth and Caregivers)

    Time frame: 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).

  6. Intervention Appropriateness Measure (Youth and Caregivers)

    Time frame: 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).

  7. Semi-Structured Interview (Adolescents Only)

    Time frame: 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.

Secondary outcomes

  1. Revised Children's Anxiety and Depression Scale - Caregiver and Child Report

    Time frame: Baseline through study completion, an average of 6 months.

    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.

  2. The Kiddie Schedule for Affective Disorders and Schizophrenia (Select Screeners and Full Modules: Schizophrenia, Mania, Eating Disorder, Suicidal Ideation; Adolescents Only)

    Time frame: 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. 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.

  3. Mental Health Statistics Improvement Program (MHSIP) Youth Survey (Caregiver and Youth Report)

    Time frame: 6 weeks post-baseline and through study completion, an average of 6 months.

    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).

  4. Therapeutic Alliance Scale for Children (TASC) - Revised (Caregiver and Child Report)

    Time frame: 6 weeks post-baseline and through study completion, an average of 6 months.

    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.

  5. Prolonged Grief Scale - 13 (Adolescents Only)

    Time frame: 6 weeks post-baseline and through study completion, an average of 6 months.

    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.

  6. Rosenberg Self Esteem Scale

    Time frame: Baseline through study completion, an average of 6 months.

    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.

  7. Multidimensional Scale of Perceived Social Support

    Time frame: Baseline through study completion, an average of 6 months.

    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.

  8. Posttraumatic Stress Disorder Checklist - 8 (Caregiver Only)

    Time frame: Baseline, 6-, 10-, 20-, 30-week follow up

    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.

  9. Alabama Parenting Questionnaire (Caregivers only)

    Time frame: Baseline through study completion, an average of 6 months.

    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.

  10. Parental Self Efficacy Scale (caregivers only)

    Time frame: Baseline through study completion, an average of 6 months.

    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.

  11. DSM-5-TR Parent/Guardian-Rated Level 1 Cross-Cutting Symptom Measure (Caregiver Report)

    Time frame: Baseline through study completion, an average of 6 months.

    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

Other outcomes

  1. Accountable Health Communities Health Related Social Needs Screening Tool - Caregiver and Child Report

    Time frame: Baseline

    Select items from the Accountable Health Communities Health Related Social Needs Screening Tool will be used to assess for factors related to social determinants of health, such as food insecurity, housing insecurity, and other basic needs. Questions are administered to caregivers and youth to characterize the sample and to connect families to resources, as needed.

  2. Adverse Childhood Events Scale - Youth Version

    Time frame: Baseline

    Adolescent participants will complete the Adverse Childhood Events Scale - Youth Version at baseline to assess for a wide range of adverse childhood events that are not captured on the CATS 2.0 including emotional abuse, divorce, familial incarceration, parental substance use, and neglect. Findings will be used to inform comprehensive trauma assessment.

  3. Measure of Adolescent Relationship Harassment and Abuse - Short Form

    Time frame: Baseline

    Adolescent participants will complete the Measure of Adolescent Relationship Harassment and Abuse - Short Form at baseline to assess for exposure to Teen Dating Violence, some of which may not otherwise be captured on the CATS 2.0. Findings will be used to inform comprehensive trauma assessment.

  4. HARK Intimate Partner Violence Screener (Caregiver Only)

    Time frame: Baseline

    The HARK will be used to screen for lifetime and past year Intimate Partner Violence among caregivers in the study at baseline.

  5. Trauma History Questionnaire (Caregivers Only)

    Time frame: Baseline

    Caregivers will complete the 24 item trauma history questionnaire to assess for trauma history among caregivers who participate in the study.

Sponsors and collaborators

Lead sponsor

Medical University of South Carolina

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Adapting Written Exposure Therapy for Adolescents With Posttraumatic Stress Disorder

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Mar 27, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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