Adolescent PCIP Randomized Feasibility Trial

NCT ID: NCT05088915

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-03
• Study Completion Date: 2026-07-30

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. 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

BREATHE Primary Care Intervention for PTSD (PCIP)

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).

Group Type: EXPERIMENTAL

Primary Care Intervention for PTSD (PCIP)

Intervention Type: 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.

Treatment As Usual

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

Group Type: ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type: BEHAVIORAL

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

Interventions

Primary Care Intervention for PTSD (PCIP)

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.

Intervention Type: BEHAVIORAL

Treatment As Usual

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

Intervention Type: BEHAVIORAL

Other Intervention Names

PCIP

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Lauren Ng, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lauren C Ng, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California Los Angeles

Los Angeles, California, United States

Countries

United States

Other Identifiers

21-000207

Identifier Type: -

Identifier Source: org_study_id