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Posttraumatic Stress Disorder (PTSD)NCT07498257

Examining Written Exposure Therapy Delivered to Adolescents

A study testing Written Exposure Therapy and Trauma-focused Cognitive Behavior Therapy in people with Posttraumatic Stress Disorder (PTSD), run by Medical University of South Carolina at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 12 to 18 years
Conditions the study is for
Posttraumatic Stress Disorder (PTSD)
What is being tested?
Written Exposure Therapy and Trauma-focused Cognitive Behavior Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
1 siteUnited States
Study dates
6 May 2026to 28 Feb 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Aim 1 (Obj. 1.1) Inclusion Criteria for Adolescents with PTSD:

  1. 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.
  2. Accompanying, consenting caregiver (exception, 18-year-olds can provide consent without accompanying caregiver)
  3. Exposure to one or more potentially traumatic event(s) on the NCVTRC clinic phone screen.
  4. Ability to comprehend English.
  5. A score of greater than or equal to 6 on the Child Trauma Screen (CTS)
  6. Residence in the state of South Carolina.

Aim 1 (Obj. 1.1) Exclusion Criteria for Adolescents with PTSD:

  1. Active psychosis, bipolar disorder, or a comorbid condition that requires a higher level of immediate care (e.g., anorexia nervosa, alcohol withdrawal).
  2. Active suicide risk with ideation, plan and intent.
  3. Active, ongoing violence, abuse, or other ongoing traumatic events that indicate immediate safety concerns.
  4. Children in foster care, kinship care, or with active Department of Social Services (DSS) investigations.
  5. History of pervasive developmental or intellectual disability.
  6. Any other medical or psychiatric condition that compromise the participant's ability to safely participate.
  7. 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:

  1. Masters-level degree or higher in psychology or a related discipline (e.g., social work; counseling).
  2. Current provider of trauma-focused treatment to adolescents with PTSD in an outpatient setting for a minimum of one year.
  3. Ability to comprehend English.
  4. Consent to participate in a one time study visit.

Aim 1 (Obj 1.1) Inclusion Criteria for Pediatric Primary Care Mental Health Providers:

  1. Masters-level degree or higher in psychology or a related discipline (e.g., social work; counseling).
  2. Current status as a mental health clinician housed in an integrated pediatric primary care setting.
  3. Ability to comprehend English.
  4. 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:

  1. 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.
  2. Accompanying consenting caregiver (exception, 18-year-olds can provide consent without accompanying caregiver)
  3. 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.
  4. Ability to comprehend English.
  5. A score of greater than or equal to 21 on the Child and Adolescent Trauma Screen (CATS).
  6. Residence in the state of South Carolina.

Aim 1 (Obj 1.2 theater testing) and Aim 2 (RCT) Exclusion Criteria for Adolescents with PTSD:

  1. Active psychosis, bipolar disorder, or a comorbid condition that requires a higher level of immediate care (e.g., anorexia nervosa, alcohol withdrawal).
  2. Active suicide risk with ideation, plan and intent.
  3. Active, ongoing violence, abuse, or other ongoing traumatic events that indicate immediate safety concerns.
  4. Children in foster care, kinship care, or with active DSS investigations.
  5. History of pervasive developmental or intellectual disability.
  6. Any other medical or psychiatric condition that compromise the participant's ability to safely participate.
  7. Inability or unwillingness of caregiver to consent for adolescent to participate (exception, 18-year-olds can participate without an accompanying caregiver).
  8. Lack of any memory of the traumatic event(s).
  9. 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

    Charleston, South Carolina, 29425

Other trials in United States

About this study

Official title: Adapting Written Exposure Therapy for Adolescents With Posttraumatic Stress Disorder

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.

Being tested
Written Exposure Therapy, Trauma-focused Cognitive Behavior Therapy
Keywords
Adolescents, Mental Health
Medical subject headings
Stress Disorders, Post-Traumatic, Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Written Exposure TherapyBehavioural

    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 TherapyBehavioural

    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.

Study groups in NCT07498257
Study groupRoleWhat they receive
Experimental Group (Written Exposure Therapy)ExperimentalNot described
Receives: Behavioral: Written Exposure Therapy
Comparison Condition (Trauma-focused Cognitive Behavior Therapy)Active comparatorNot described
Receives: Behavioral: Trauma-focused Cognitive Behavior Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

  3. 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).

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

  4. 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).

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

  5. 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).

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

  6. 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).

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

  7. 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.

    Measured: 6 week follow up (WET condition only)

Secondary outcomes (11)

  1. 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.

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

  2. 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.

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

  3. 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).

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

    Measured: Baseline, 6-, 10-, 20-, 30-week follow up

  9. 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.

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

  10. 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.

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

  11. 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2026
  2. Study start6 May 2026
  3. Primary completion28 Feb 2031 (estimated)
  4. Study completion28 Feb 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants (n=48) in the Randomized Controlled Trial (RCT) will be randomized in a 2:1 fashion to either the experimental group (Written Exposure Therapy; n=32) or the comparison condition (Trauma-focused Cognitive Behavior Therapy; n = 16).
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
48 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07498257
Sponsor's protocol ID
Pro00149514
Status last verified
Sep 2026
First submitted
23 Mar 2026
Last updated
15 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sloan DM, Marx BP, Lee DJ, Resick PA. A Brief Exposure-Based Treatment vs Cognitive Processing Therapy for Posttraumatic Stress Disorder: A Randomized Noninferiority Clinical Trial. JAMA Psychiatry. 2018 Mar 1;75(3):233-239. doi: 10.1001/jamapsychiatry.2017.4249.

    PubMed 29344631

  • Sloan DM, Marx BP, Acierno R, Messina M, Muzzy W, Gallagher MW, Litwack S, Sloan C. Written Exposure Therapy vs Prolonged Exposure Therapy in the Treatment of Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2023 Nov 1;80(11):1093-1100. doi: 10.1001/jamapsychiatry.2023.2810.

    PubMed 37610727

  • LoSavio ST, Worley CB, Aajmain ST, Rosen CS, Wiltsey Stirman S, Sloan DM. Effectiveness of written exposure therapy for posttraumatic stress disorder in the Department of Veterans Affairs Healthcare System. Psychol Trauma. 2023 Jul;15(5):748-756. doi: 10.1037/tra0001148. Epub 2021 Oct 28.

    PubMed 34726451

Questions about this trial

What is this clinical trial studying?

A study testing Written Exposure Therapy and Trauma-focused Cognitive Behavior Therapy in people with Posttraumatic Stress Disorder (PTSD), run by Medical University of South Carolina at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS; Adolescents Only) (time frame: Baseline through study completion, an average of 6 months.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07498257, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.

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