Adolescent PCIP Randomized Feasibility Trial

NCT05088915 | Withdrawn

• 1 other identifier: 21-000207
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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 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=44 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. 1.Assess the reach and adoption of the protocol by analyzing quantitative data on patient and clinic staff participation, retention, and satisfaction;
2. 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. 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.

Conditions

Post-Traumatic Stress Disorder in Adolescence; Post Traumatic Stress Disorder

Keywords

Adolescent; Primary Care; PTSD; Post Traumatic Stress Disorder; Randomized Feasibility Trial; TF-CBT

Outcome Measures

Primary Outcomes (5)

• Change in PTSD Knowledge

  Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)

  Day 0 baseline, 10 months

• Change in Trauma-Related Cognitions

  Changes in post-traumatic cognitions measured by the Post-Traumatic Cognitions Inventory (1-7, Higher scores indicating more post traumatic cognitions)

  Day 0 baseline, 10 months

• Change in Self-Reported Arousal

  Changes in PTSD related arousal levels measured by the Composite Autonomic Symptom Score (COMPASS-31; 0-100 total, Higher scores indicating higher arousal)

  Day 0 baseline, 10 months

• Change in Stress Management Skill Use

  Changes in PTSD related arousal levels measured Measure of Adolescent Coping Strategies (MACS; Total 0-102, higher scores indicate higher use of specified coping), and use of the breathing retraining techniques as measured by self-reports during in-session review.

  Day 0 baseline, 10 months

• Intervention Implementation and Acceptability

  Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth. Additionally, data will be collected regarding participant completion of therapy, no show rates, barriers to treatment, and attendance. Additionally, study therapists will complete qualitative and quantitative measures regarding intervention delivery feasibility and study protocols.

  Day 0 baseline, 10 months

Secondary Outcomes (10)

• Change in PTSD Symptoms

  Day 0 baseline, 10 months

• Change in Trauma Symptoms

  Day 0 baseline, 10 months

• Change in Adverse Childhood Experiences

  Day 0 baseline, 10 months

• Change in Depression Symptoms

  Day 0 baseline, 10 months

• Change in Depression Symptoms

  Day 0 baseline, 10 months

Study Arms (2)

BREATHE Primary Care Intervention for PTSD (PCIP)

EXPERIMENTAL

BREATHE PCIP is a treatment for Post-Traumatic Stress Disorder (PTSD) symptoms for use with individuals who have a diagnosis of PTSD or "probable PTSD." The treatment will be considered delivered when patients have learned and practiced breathing retraining and have discussed the symptoms of PTSD (Sessions 1 through 3).

Behavioral: Primary Care Intervention for PTSD (PCIP)

Treatment As Usual

ACTIVE COMPARATOR

Receive standard care treatment and provided information on free or low cost mental health care referrals in the Los Angeles Area.

Behavioral: Treatment As Usual

Interventions

Primary Care Intervention for PTSD (PCIP) BEHAVIORAL

This program is adapted from the "B.R.E.A.T.H.E. - Brief Relaxation, Education and Trauma Healing: A Brief Intervention for Persons with PTSD and Co- Occurring Serious Mental Health Conditions. Treatment Program Manual and Patient Handouts (Version 3) by Kim T. Mueser, Rachael Fite, Stanley D. Rosenberg, and Jennifer D. Gottlieb.

Also known as: PCIP

BREATHE Primary Care Intervention for PTSD (PCIP)

Treatment As Usual BEHAVIORAL

Receive standard care treatment and are provided information on free or low cost mental health care referrals in the Los Angeles Area.

Treatment As Usual

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patient referred to the SHARK Program
• Patients must be at least 12 years old
• Screened for probable PTSD on UCLA RI, or at provider discretion of clinical relevancy.
• 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;
• Patient is able to complete study activities in English.

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Lauren C Ng, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This study will utilize a hybrid effectiveness-implementation approach to conduct a randomized pilot feasibility trial of the PCIP screening and intervention protocol in adolescent primary care with two treatment arms: 1. PCIP delivered through telehealth (computer or smartphone delivered videocall) 2. Treatment as usual (TAU)

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 22, 2021
• Study Start: January 3, 2022
• Primary Completion: December 20, 2025
• Study Completion: December 20, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)