Adaptation of the PCIP for Spanish Speaking Adolescents and Families

NCT05899322 | Withdrawn

• 1 other identifier: #22-001744
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• Change in PTSD Knowledge

  Changes in levels of PTSD Knowledge measured by the PTSD Knowledge Test (0-14, higher scores indicating more PTSD knowledge)

  Day 0 baseline, 1 month follow-up

• 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)

  Day 0 baseline, 1 month follow-up

• Intervention Acceptability

  Qualitative interviews will include questions regarding acceptability of treatment including treatment via telehealth and barriers to treatment.

  post treatment, average 1 month after enrollment

• Intervention Engagement

  Data will be collected regarding participant completion of therapy, no show rates, and attendance.

  post treatment, average 1 month after enrollment

• Intervention Implementation

  Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.

  post treatment, average 1 month after enrollment

Secondary Outcomes (6)

• Change in PTSD Symptoms

  Day 0 baseline, 1 month follow-up

• Change in Trauma Symptoms

  Day 0 baseline, 1 month follow-up

• Change in Depression Symptoms

  Day 0 baseline, 1 month follow-up

• Change in Anxiety Symptoms

  Day 0 baseline, 1 month follow-up

• Change in Functional Impairment

  Day 0 baseline, 1 month follow-up

Study Arms (2)

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

EXPERIMENTAL

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.

Behavioral: Primary Care Intervention for PTSD Spanish Speaking Adolescents

Waitlist Treatment as Usual

ACTIVE COMPARATOR

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.

Behavioral: Waitlist Treatment as Usual

Interventions

Primary Care Intervention for PTSD Spanish Speaking Adolescents BEHAVIORAL

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.

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

Waitlist Treatment as Usual BEHAVIORAL

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.

Waitlist Treatment as Usual

Eligibility Criteria

• Age: 12 Years - 22 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Lauren C Ng, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Mixed methods (qualitative and quantitative) randomized pilot feasibility trial (n=10 to treatment and 10 to waitlist control)

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 12, 2023
• Study Start: June 12, 2023
• Primary Completion: July 24, 2025
• Study Completion: July 24, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)