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Adolescent PCIP Randomized Feasibility Trial (APCIP)

Primary Purpose

Post-Traumatic Stress Disorder in Adolescence, Post Traumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Primary Care Intervention for PTSD (PCIP)
Treatment As Usual
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-Traumatic Stress Disorder in Adolescence focused on measuring Adolescent, Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Feasibility Trial, TF-CBT

Eligibility Criteria

12 Years - 22 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of California Los AngelesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BREATHE Primary Care Intervention for PTSD (PCIP)

Treatment As Usual

Arm Description

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).

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

Outcomes

Primary Outcome Measures

Change in PTSD Knowledge
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
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
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
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
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
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
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
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
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
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
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
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
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
Changes in pro-inflammatory transcription factor activation including NF-κB/Rel will be analyzed from Dried Blood Spots (DBS)
Change in Substance Use
Changes in substance use and misuse measured by CRAFFT Adolescent Substance Use Screen (0-9, Higher scores indicate higher risk for substance misuse)

Full Information

First Posted
September 29, 2021
Last Updated
January 18, 2023
Sponsor
University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05088915
Brief Title
Adolescent PCIP Randomized Feasibility Trial
Acronym
APCIP
Official Title
Adolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 3, 2022 (Actual)
Primary Completion Date
December 20, 2023 (Anticipated)
Study Completion Date
July 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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 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, 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-Traumatic Stress Disorder in Adolescence, Post Traumatic Stress Disorder
Keywords
Adolescent, Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Feasibility Trial, TF-CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 two treatment arms: PCIP delivered through telehealth (computer or smartphone delivered videocall) Treatment as usual (TAU)
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BREATHE Primary Care Intervention for PTSD (PCIP)
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment As Usual
Arm Type
Active Comparator
Arm Description
Receive standard care treatment and provided information on free or low cost mental health care referrals in the Los Angeles Area.
Intervention Type
Behavioral
Intervention Name(s)
Primary Care Intervention for PTSD (PCIP)
Other Intervention Name(s)
PCIP
Intervention Description
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
Intervention Name(s)
Treatment As Usual
Intervention Description
Receive standard care treatment and are provided information on free or low cost mental health care referrals in the Los Angeles Area.
Primary Outcome Measure Information:
Title
Change in PTSD Knowledge
Description
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)
Time Frame
Day 0 baseline, 10 months
Title
Change in Trauma-Related Cognitions
Description
Changes in post-traumatic cognitions measured by the Post-Traumatic Cognitions Inventory (1-7, Higher scores indicating more post traumatic cognitions)
Time Frame
Day 0 baseline, 10 months
Title
Change in Self-Reported Arousal
Description
Changes in PTSD related arousal levels measured by the Composite Autonomic Symptom Score (COMPASS-31; 0-100 total, Higher scores indicating higher arousal)
Time Frame
Day 0 baseline, 10 months
Title
Change in Stress Management Skill Use
Description
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.
Time Frame
Day 0 baseline, 10 months
Title
Intervention Implementation and Acceptability
Description
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.
Time Frame
Day 0 baseline, 10 months
Secondary Outcome Measure Information:
Title
Change in PTSD Symptoms
Description
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)
Time Frame
Day 0 baseline, 10 months
Title
Change in Trauma Symptoms
Description
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).
Time Frame
Day 0 baseline, 10 months
Title
Change in Adverse Childhood Experiences
Description
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.
Time Frame
Day 0 baseline, 10 months
Title
Change in Depression Symptoms
Description
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).
Time Frame
Day 0 baseline, 10 months
Title
Change in Depression Symptoms
Description
Changes in depression symptoms measured by the Patient Health Questionnaire (PHQ-9;0-27; Higher scores indicate higher symptoms and likelihood of depression)
Time Frame
Day 0 baseline, 10 months
Title
Change in Anxiety Symptoms
Description
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).
Time Frame
Day 0 baseline, 10 months
Title
Change in Functional Impairment
Description
Changes in functional impairment measured by The Columbia Impairment Scale (C.I.S.; 0-52, Higher scores indicate greater impairment).
Time Frame
Day 0 baseline, 10 months
Title
Change in pro-inflammatory cytokine biomarkers
Description
Changes in pro-inflammatory cytokines including TNF-α, IL-6, IFN-γ and IL-1ß will be analyzed from Dried Blood Spots (DBS)
Time Frame
Day 0 baseline, 10 months
Title
Change in pro-inflammatory transcription factor activation
Description
Changes in pro-inflammatory transcription factor activation including NF-κB/Rel will be analyzed from Dried Blood Spots (DBS)
Time Frame
Day 0 baseline, 10 months
Title
Change in Substance Use
Description
Changes in substance use and misuse measured by CRAFFT Adolescent Substance Use Screen (0-9, Higher scores indicate higher risk for substance misuse)
Time Frame
Day 0 baseline, 10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gray K Bowers, MA
Phone
310-810-8553
Email
graybowers@ucla.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren C Ng, PhD
Phone
310-794-9137
Email
laurenng@ucla.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren C Ng, PhD
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gray Bowers, MA
Phone
310-810-8553
Email
graybowers@ucla.edu
First Name & Middle Initial & Last Name & Degree
Lauren C Ng, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Adolescent PCIP Randomized Feasibility Trial

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