Clinical trial NCT05088915: Adolescent PCIP Randomized Feasibility Trial
Official title: Adolescent BREATHE Primary Care Intervention for PTSD (PCIP) Randomized Feasibility Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Post-Traumatic Stress Disorder in Adolescence
Post Traumatic Stress Disorder
Keywords: Adolescent
Primary Care
PTSD
Post Traumatic Stress Disorder
Randomized Feasibility Trial
TF-CBT
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2021-10-22
Enrollment: 44
Sex: ALL
Minimum age (years): 12
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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 two treatment arms:

1. PCIP delivered through telehealth (computer or smartphone delivered videocall)
2. Treatment as usual (TAU)
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change in PTSD Knowledge
timeFrame: Day 0 baseline, 10 months
measure: Change in Trauma-Related Cognitions
timeFrame: Day 0 baseline, 10 months
measure: Change in Self-Reported Arousal
timeFrame: Day 0 baseline, 10 months
measure: Change in Stress Management Skill Use
timeFrame: Day 0 baseline, 10 months
measure: Intervention Implementation and Acceptability
timeFrame: Day 0 baseline, 10 months
Secondary outcomes:
measure: Change in PTSD Symptoms
timeFrame: Day 0 baseline, 10 months
measure: Change in Trauma Symptoms
timeFrame: Day 0 baseline, 10 months
measure: Change in Adverse Childhood Experiences
timeFrame: Day 0 baseline, 10 months
measure: Change in Depression Symptoms
timeFrame: Day 0 baseline, 10 months
measure: Change in Depression Symptoms
timeFrame: Day 0 baseline, 10 months
measure: Change in Anxiety Symptoms
timeFrame: Day 0 baseline, 10 months
measure: Change in Functional Impairment
timeFrame: Day 0 baseline, 10 months
measure: Change in pro-inflammatory cytokine biomarkers
timeFrame: Day 0 baseline, 10 months
measure: Change in pro-inflammatory transcription factor activation
timeFrame: Day 0 baseline, 10 months
measure: Change in Substance Use
timeFrame: Day 0 baseline, 10 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Lauren C Ng, PhD
role: PRINCIPAL_INVESTIGATOR
References: