NCT05088915

Adolescent PCIP Randomized Feasibility Trial

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, Los Angeles · Academic / Other
• Sex: All
• Age: 12 Years – 22 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2022-01-03
• Primary completion: 2025-12-20
• Completion: 2025-12-20
• First posted: 2021-10-22
• Last updated: 2026-02-27

Locations

1 site across 1 country: United States