Summary

Eligibility
for people ages 12-22 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCLA
Dates
study started
estimated completion
Principal Investigator
by Lauren Ng (ucla)

Description

Summary

There are three research questions: (1) whether the Primary Care Intervention for PTSD (PCIP) improves health outcomes; (2) whether and how the PCIP can be sustainably delivered via telehealth; and (3) how PCIP compares to trauma focused cognitive behavioral therapy and treatment as usual (TAU) participants. The mixed methods randomized feasibility trial of the protocol will be measured by the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance) (n=45 patients and their care givers). We will collect data on patient, caregiver, and clinic staff participation, retention, and satisfaction (Reach and Adoption), change in hypothesized treatment mechanisms and symptoms (Effectiveness), and facilitators and barriers to intervention delivery and fidelity (Implementation). We will, 1. Assess the reach and adoption of the protocol by analyzing quantitative data on patient and clinic staff participation, retention, and satisfaction; 2. Explore the effectiveness of the protocol through medical record review, quantitative assessments at baseline and post-treatment, and semi-structured qualitative interviews at baseline and post-treatment to: 3. Evaluate the implementation of the screening and intervention protocol with post-intervention semi-structured qualitative interviews to assess facilitators and barriers to intervention delivery, quantitative fidelity scales, observation of screening, and review of intervention audio recordings to assess fidelity to the protocol and intervention process.

Official Title

Adolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial

Keywords

Post-Traumatic Stress Disorder in Adolescence Post Traumatic Stress Disorder Adolescent Primary Care PTSD Randomized Feasibility Trial TF-CBT Disease Stress Disorders, Traumatic Stress Disorders, Post-Traumatic BREATHE Primary Care Intervention for PTSD (PCIP) Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Eligibility

You can join if…

Open to people ages 12-22

  1. Patient referred to the SHARK Program
  2. Patients must be at least 12 years old
  3. Screened for probable PTSD on UCLA RI, or at provider discretion of clinical relevancy.
  4. If patient is under 18 years old, the patient's legal guardian is able and willing to provide informed consent for the patient to participate in the study;
  5. Patient is able to complete study activities in English.

You CAN'T join if...

  1. Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days;
  2. Inability to provide informed consent or assent, and/or complete procedures in English.

Location

  • University of California Los Angeles accepting new patients
    Los Angeles California 90095 United States

Lead Scientist at University of California Health

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Los Angeles
ID
NCT05088915
Study Type
Interventional
Participants
Expecting 45 study participants
Last Updated