Adolescent PCIP Randomized Feasibility Trial (APCIP)

University of California, Los Angeles (UCLA)

Status: Suspended

Conditions: Post Traumatic Stress Disorder; Post-Traumatic Stress Disorder in Adolescence

Treatments: Behavioral: Primary Care Intervention for PTSD (PCIP); Behavioral: Treatment As Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT05088915

21-000207

Details and patient eligibility

About

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.

Enrollment: 44 estimated patients

Sex: All

Ages: 12 to 22 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

BREATHE Primary Care Intervention for PTSD (PCIP)

Experimental group

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).

Treatment:

Behavioral: Primary Care Intervention for PTSD (PCIP)

Treatment As Usual

Active Comparator group

Description:

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

Treatment:

Behavioral: Treatment As Usual