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Adaptation of the PCIP for Spanish Speaking Adolescents and Families

Primary Purpose

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

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Primary Care Intervention for PTSD Spanish Speaking Adolescents
Waitlist 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 Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Pilot Feasibility Trial, Spanish speaking adaptation

Eligibility Criteria

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

Inclusion Criteria: Patient referred to the SHARK Program Patients must be at least 12 years old Screened for probable PTSD on Brief UCLA Reaction Index, 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 in English or Spanish; Patient is able to complete study activities in English or Spanish. Exclusion Criteria: Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days; Patient is over the age of 22

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Primary Care Intervention for PTSD (PCIP) Spanish Speaking Adolescents and Families

    Waitlist Treatment as Usual

    Arm Description

    This arm will receive the culturally adapted and translated PCIP intervention lasting from 1-3 weeks, and will complete baseline, post treatment, and 1-month follow up assessments.

    Receive standard care treatment and will complete baseline, post treatment, and 1-month follow up assessments, and are offered translated and adapted PCIP treatment after conclusion of the study.

    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 Self-Reported Arousal
    Changes in PTSD related arousal levels measured by the Self-Assessment Manikin (SAM; 0-24, higher scores indicating higher arousal)
    Intervention Acceptability
    Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.
    Intervention Engagement
    Data will be collected regarding participant completion of therapy, no show rates, and attendance.
    Intervention Implementation
    Study therapists will complete qualitative interviews 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 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 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
    May 24, 2023
    Last Updated
    June 2, 2023
    Sponsor
    University of California, Los Angeles
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05899322
    Brief Title
    Adaptation of the PCIP for Spanish Speaking Adolescents and Families
    Official Title
    Adaptation and Translation of the Primary Care Intervention for PTSD for Spanish Speaking Adolescents and Families
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 12, 2023 (Anticipated)
    Primary Completion Date
    August 15, 2023 (Anticipated)
    Study Completion Date
    December 15, 2023 (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
    This study will implement a brief Post-traumatic Stress Disorder (PTSD) intervention for children, the Primary Care Intervention for PTSD (PCIP) delivered through telehealth (computer or smart phone delivery), to 10 Spanish speaking youth and their families. Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control) to refine the intervention, study procedures, and explore effectiveness. Following RE-AIM guidelines, the investigators will assess: Reach: patient participation in intervention delivery (out of all those asked to participate) and retention rate (out of all those who consented to participate and completed at least two intervention sessions) Adoption: patients and their parents/guardians will complete screening and intervention satisfaction ratings. To understand patient experiences with the intervention and to identify and explain positive or negative treatment mechanisms or effects, the investigators will conduct post-intervention semi-structured interviews with the participating patients, their parents/guardians, and with providers. This treatment ranges from 1-3 sessions which last 30-50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the parent or both the parent and child. The first session will also teach the parent and child a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the child's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that the parent and child can learn together. There is also material for parents to address behavior problems in youth. This treatment will be delivered via telehealth. All treatment materials have been developed in both Spanish and English.

    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
    Primary Care, PTSD, Post Traumatic Stress Disorder, Randomized Pilot Feasibility Trial, Spanish speaking adaptation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control)
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Primary Care Intervention for PTSD (PCIP) Spanish Speaking Adolescents and Families
    Arm Type
    Experimental
    Arm Description
    This arm will receive the culturally adapted and translated PCIP intervention lasting from 1-3 weeks, and will complete baseline, post treatment, and 1-month follow up assessments.
    Arm Title
    Waitlist Treatment as Usual
    Arm Type
    Active Comparator
    Arm Description
    Receive standard care treatment and will complete baseline, post treatment, and 1-month follow up assessments, and are offered translated and adapted PCIP treatment after conclusion of the study.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Primary Care Intervention for PTSD Spanish Speaking Adolescents
    Intervention Description
    This treatment ranges from 1-3 sessions which last 30-50 minutes per session. The first session will cover psychoeducation about PTSD symptoms in children that can be delivered to the adolescent with optional parent involvement. The first session will also teach the adolescent a breathing technique to combat the physiological impact of PTSD in children. The subsequent sessions will be tailored to meet the needs of the adolescent's most distressing PTSD symptom cluster including hyper arousal, negative changes in cognition and mood, avoidance, re-experiencing. Each session contains coping skills that address the adolescent's symptoms. This treatment will be delivered via telehealth and all materials have been developed in both Spanish and English.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Waitlist Treatment as Usual
    Intervention Description
    Will receive treatment as usual at local clinic 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, 1 month follow-up
    Title
    Change in Self-Reported Arousal
    Description
    Changes in PTSD related arousal levels measured by the Self-Assessment Manikin (SAM; 0-24, higher scores indicating higher arousal)
    Time Frame
    Day 0 baseline, 1 month follow-up
    Title
    Intervention Acceptability
    Description
    Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.
    Time Frame
    post treatment, average 1 month after enrollment
    Title
    Intervention Engagement
    Description
    Data will be collected regarding participant completion of therapy, no show rates, and attendance.
    Time Frame
    post treatment, average 1 month after enrollment
    Title
    Intervention Implementation
    Description
    Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.
    Time Frame
    post treatment, average 1 month after enrollment
    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, 1 month follow-up
    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, 1 month follow-up
    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, 1 month follow-up
    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, 1 month follow-up
    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, 1 month follow-up
    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, 1 month follow-up

    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 Brief UCLA Reaction Index, 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 in English or Spanish; Patient is able to complete study activities in English or Spanish. Exclusion Criteria: Suicidal ideation with a plan within the last two weeks or a suicide attempt within the past 30 days; Patient is over the age of 22
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Adaptation of the PCIP for Spanish Speaking Adolescents and Families

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