Adaptation of the PCIP for Spanish Speaking Adolescents and Families

Not Applicable

Suspended

• Conditions: Post-Traumatic Stress Disorder in Adolescence; Post Traumatic Stress Disorder
• Interventions: Behavioral: Primary Care Intervention for PTSD Spanish Speaking Adolescents; Behavioral: Waitlist Treatment as Usual

• Registration Number: NCT05899322
• Lead Sponsor: University of California, Los Angeles

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-24
• Study First Submitted QC: 2023-06-02
• Study Start: 2023-06-12
• Study First Posted: 2023-06-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-17
• Last Update Posted: 2024-07-18
• Primary Completion: 2025-04-15
• Study Completion: 2025-08-15

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Primary Care Intervention for PTSD (PCIP) Spanish Speaking Adolescents and Families	Primary Care Intervention for PTSD Spanish Speaking Adolescents	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.
Waitlist Treatment as Usual	Waitlist Treatment as Usual	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.

Primary Outcome Measures

Name	Time	Method
Intervention Engagement	post treatment, average 1 month after enrollment	Data will be collected regarding participant completion of therapy, no show rates, and attendance.
Intervention Implementation	post treatment, average 1 month after enrollment	Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.
Change in PTSD Knowledge	Day 0 baseline, 1 month follow-up	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	Day 0 baseline, 1 month follow-up	Changes in PTSD related arousal levels measured by the Self-Assessment Manikin (SAM; 0-24, higher scores indicating higher arousal)
Intervention Acceptability	post treatment, average 1 month after enrollment	Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.

Secondary Outcome Measures

Name	Time	Method
Change in PTSD Symptoms	Day 0 baseline, 1 month follow-up	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 Functional Impairment	Day 0 baseline, 1 month follow-up	Changes in functional impairment measured by The Columbia Impairment Scale (C.I.S.; 0-52, Higher scores indicate greater impairment).
Change in Anxiety Symptoms	Day 0 baseline, 1 month follow-up	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 Substance Use	Day 0 baseline, 1 month follow-up	Changes in substance use and misuse measured by CRAFFT Adolescent Substance Use Screen (0-9, Higher scores indicate higher risk for substance misuse).
Change in Depression Symptoms	Day 0 baseline, 1 month follow-up	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 Trauma Symptoms	Day 0 baseline, 1 month follow-up	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).

Trial Locations

Locations (1)

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States