APCIP: Adolescent PCIP Randomized Feasibility Trial

Sponsor

University of California, Los Angeles (Other)

Overall Status

Recruiting

CT.gov ID

NCT05088915

Collaborator

(none)

Enrollment

Location

Arms

16.9

Anticipated Duration (Months)

2.7

Patients Per Site Per Month

Study Details

Study Description

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 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,

Assess the reach and adoption of the protocol by analyzing quantitative data on patient and clinic staff participation, retention, and satisfaction;
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:
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.

Condition or Disease	Intervention/Treatment	Phase
Post-Traumatic Stress Disorder in Adolescence Post Traumatic Stress Disorder	Behavioral: BREATHE Primary Care Intervention for PTSD (PCIP) Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) Behavioral: Treatment As Usual	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 three treatment arms: PCIP delivered through telehealth (computer or smartphone delivered videocall) TF-CBT delivered through telehealth Treatment as usual (TAU)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 three treatment arms:PCIP delivered through telehealth (computer or smartphone delivered videocall) TF-CBT delivered through telehealth Treatment as usual (TAU)

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 3, 2022

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	Behavioral: BREATHE 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. Other Names: PCIP
Active Comparator: Trauma-Focused Cognitive Behavioral Therapy TF-CBT model is a brief (8-25 session), cognitive-behavioral, resiliency-building, components- and phase-based model for trauma-impacted children or adolescents and their parents and caregivers.	Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) Nine TF-CBT components exist which are summarized by the acronym "PRACTICE". " These components are contained within three phases that are typically provided in equal length. Three phases exist as follows: Phase 1: Stabilization Skills Phase 2: Trauma Narration and Processing Phase 3: Consolidation Conjoint child-parent sessions to enhance communication about the child's trauma experiences and general parent-child communication Enhancing safety and future development to address these issues. During each TF-CBT session, the therapist meets for about half of the session with the child and about half of the session with the parent or caregiver (during the conjoint sessions, most of the session is spent with the child and parent together).
Active Comparator: Treatment As Usual 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 Receive standard care treatment and are provided information on free or low cost mental health care referrals in the Los Angeles Area.

Arm

Intervention/Treatment

Experimental: 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).

Behavioral: BREATHE 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.

Other Names:

PCIP

Active Comparator: Trauma-Focused Cognitive Behavioral Therapy

TF-CBT model is a brief (8-25 session), cognitive-behavioral, resiliency-building, components- and phase-based model for trauma-impacted children or adolescents and their parents and caregivers.

Behavioral: Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)

Nine TF-CBT components exist which are summarized by the acronym "PRACTICE". " These components are contained within three phases that are typically provided in equal length. Three phases exist as follows: Phase 1: Stabilization Skills Phase 2: Trauma Narration and Processing Phase 3: Consolidation Conjoint child-parent sessions to enhance communication about the child's trauma experiences and general parent-child communication Enhancing safety and future development to address these issues. During each TF-CBT session, the therapist meets for about half of the session with the child and about half of the session with the parent or caregiver (during the conjoint sessions, most of the session is spent with the child and parent together).

Active Comparator: Treatment As Usual

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

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

Outcome Measures

Primary Outcome Measures

Change in PTSD Knowledge [Day 0 baseline, 10 months]
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)
Change in Trauma-Related Cognitions [Day 0 baseline, 10 months]
Changes in post-traumatic cognitions measured by the Post-Traumatic Cognitions Inventory (1-7, Higher scores indicating more post traumatic cognitions)
Change in Self-Reported Arousal [Day 0 baseline, 10 months]
Changes in PTSD related arousal levels measured by the Composite Autonomic Symptom Score (COMPASS-31; 0-100 total, Higher scores indicating higher arousal)
Change in Stress Management Skill Use [Day 0 baseline, 10 months]
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.
Intervention Implementation and Acceptability [Day 0 baseline, 10 months]
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.

Secondary Outcome Measures

Change in PTSD Symptoms [Day 0 baseline, 10 months]
Changes in PTSD related symptoms measured by the UCLA Child/Adolescent PTSD Reaction Index for DSM-5 Brief Screen (total 0-44; Higher scores indicate higher likelihood of PTSD and symptom-related distress and impairment)
Change in Trauma Symptoms [Day 0 baseline, 10 months]
Changes in trauma related symptoms measured by The Child PTSD Symptom Scale (CPSS-5-SR) Self Report (total 0-80, Higher scores indicated greater symptom severity).
Change in Adverse Childhood Experiences [Day 0 baseline, 10 months]
Changes in Adverse Childhood Experiences measured by the Pediatric ACEs and Related Life Events Screener (PEARLS; 0-19, higher scores indicate higher risk of traumatic stress.
Change in Depression Symptoms [Day 0 baseline, 10 months]
Changes in depression symptoms measured by the Center for Epidemiologic Studies Depression Scale (CES-DC) Self Report (total 0-60, Higher scores indicate higher symptom severity).
Change in Depression Symptoms [Day 0 baseline, 10 months]
Changes in depression symptoms measured by the Patient Health Questionnaire (PHQ-9;0-27; Higher scores indicate higher symptoms and likelihood of depression)
Change in Anxiety Symptoms [Day 0 baseline, 10 months]
Changes in anxiety symptoms measured by the Revised Children's Anxiety and Depression Scale (RCADS) Self Report (total 0-141, Higher scores indicating higher symptom severity).
Change in Functional Impairment [Day 0 baseline, 10 months]
Changes in functional impairment measured by The Columbia Impairment Scale (C.I.S.; 0-52, Higher scores indicate greater impairment).
Change in pro-inflammatory cytokine biomarkers [Day 0 baseline, 10 months]
Changes in pro-inflammatory cytokines including TNF-α, IL-6, IFN-γ and IL-1ß will be analyzed from Dried Blood Spots (DBS)
Change in pro-inflammatory transcription factor activation [Day 0 baseline, 10 months]
Changes in pro-inflammatory transcription factor activation including NF-κB/Rel will be analyzed from Dried Blood Spots (DBS)
Change in Substance Use [Day 0 baseline, 10 months]
Changes in substance use and misuse measured by CRAFFT Adolescent Substance Use Screen (0-9, Higher scores indicate higher risk for substance misuse)

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 22 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.