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NOT YET RECRUITING

NCT07498257

Adaptation and Randomized Controlled Trial of Written Exposure Therapy for Adolescents

Sponsor: Medical University of South Carolina

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

12 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-04-05

Completion Date

2031-02-28

Last Updated

2026-04-01

Healthy Volunteers

Conditions

Posttraumatic Stress Disorder (PTSD)

Interventions

BEHAVIORAL

Written Exposure Therapy

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 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.

BEHAVIORAL

Trauma-focused Cognitive Behavior Therapy

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.

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.

Locations (1)

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

Charleston, South Carolina, United States