Post-Traumatic Stress Disorder in AdolescenceAPCIPNCT05088915
Adolescent PCIP Randomized Feasibility Trial
A study testing Primary Care Intervention for PTSD (PCIP) and Treatment As Usual in people with Post-Traumatic Stress Disorder in Adolescence and Post Traumatic Stress Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Traumatic Stress Disorder in Adolescence, Post Traumatic Stress Disorder
- What is being tested?
- Primary Care Intervention for PTSD (PCIP) and Treatment As Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2022to 20 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California Los Angeles
Los Angeles, California, 90095
About this study
Official title: Adolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial
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.
- Being tested
- Primary Care Intervention for PTSD (PCIP), Treatment As Usual
- Keywords
- Adolescent, Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Feasibility Trial, TF-CBT
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Care Intervention for PTSD (PCIP)Behavioural
Also called 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.
Treatment As UsualBehavioural
Receive standard care treatment and are provided information on free or low cost mental health care referrals in the Los Angeles Area.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Behavioral: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in PTSD Knowledge
Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: Day 0 baseline, 10 months
Secondary outcomes (10)
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)
Measured: Day 0 baseline, 10 months
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).
Measured: Day 0 baseline, 10 months
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.
Measured: Day 0 baseline, 10 months
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).
Measured: Day 0 baseline, 10 months
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)
Measured: Day 0 baseline, 10 months
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).
Measured: Day 0 baseline, 10 months
Change in Functional Impairment
Changes in functional impairment measured by The Columbia Impairment Scale (C.I.S.; 0-52, Higher scores indicate greater impairment).
Measured: Day 0 baseline, 10 months
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)
Measured: Day 0 baseline, 10 months
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)
Measured: Day 0 baseline, 10 months
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)
Measured: Day 0 baseline, 10 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start3 Jan 2022
- Primary completion20 Dec 2025
- Study completion20 Dec 2025
Why it stopped: The study site preferred to conduct a non-randomized QI project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Traumatic Stress Disorder in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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: 1. PCIP delivered through telehealth (computer or smartphone delivered videocall) 2. Treatment as usual (TAU)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lauren Ng, PhD, University of California, Los Angeles
- Investigators
- Lauren C Ng, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05088915
- Sponsor's protocol ID
- 21-000207
- Acronym
- APCIP
- Status last verified
- Feb 2026
- First submitted
- 29 Sep 2021
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial
- ClinicalTrials.gov ID
- NCT05088915
- Acronym / sponsor ID
- APCIP / 21-000207
- Keywords
- Adolescent, Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Feasibility Trial, TF-CBT
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The study site preferred to conduct a non-randomized QI project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- 3 Jan 2022 (actual)
- Primary completion
- 20 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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: 1. PCIP delivered through telehealth (computer or smartphone delivered videocall) 2. Treatment as usual (TAU)
| Arm | Type | Receives |
|---|---|---|
| BREATHE Primary Care Intervention for PTSD (PCIP) | Experimental | Behavioral: 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). |
| Treatment As Usual | Active comparator | Behavioral: Treatment As UsualReceive standard care treatment and provided information on free or low cost mental health care referrals in the Los Angeles Area. |
Who may qualify
- Ages
- 12 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Care Intervention for PTSD (PCIP)Also: PCIPThis 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. | Behavioural | BREATHE Primary Care Intervention for PTSD (PCIP) |
| Treatment As UsualReceive standard care treatment and are provided information on free or low cost mental health care referrals in the Los Angeles Area. | Behavioural | Treatment As Usual |
Primary outcome
Change in PTSD Knowledge
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
10 secondary outcomes
Change in PTSD Symptoms
Time frame: Day 0 baseline, 10 months
Change in Trauma Symptoms
Time frame: Day 0 baseline, 10 months
Change in Adverse Childhood Experiences
Time frame: Day 0 baseline, 10 months
Change in Depression Symptoms
Time frame: Day 0 baseline, 10 months
Change in Depression Symptoms
Time frame: Day 0 baseline, 10 months
Change in Anxiety Symptoms
Time frame: Day 0 baseline, 10 months
Change in Functional Impairment
Time frame: Day 0 baseline, 10 months
Change in pro-inflammatory cytokine biomarkers
Time frame: Day 0 baseline, 10 months
Change in pro-inflammatory transcription factor activation
Time frame: Day 0 baseline, 10 months
Change in Substance Use
Time frame: Day 0 baseline, 10 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lauren C Ng, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary Care Intervention for PTSD (PCIP) and Treatment As Usual in people with Post-Traumatic Stress Disorder in Adolescence and Post Traumatic Stress Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PTSD Knowledge (time frame: Day 0 baseline, 10 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.