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Clinical Trials/NCT05899322
NCT05899322
Withdrawn
Not Applicable

Adaptation and Translation of the Primary Care Intervention for PTSD for Spanish Speaking Adolescents and Families

University of California, Los Angeles1 site in 1 country20 target enrollmentJune 12, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-Traumatic Stress Disorder in Adolescence
Sponsor
University of California, Los Angeles
Enrollment
20
Locations
1
Primary Endpoint
Intervention Engagement
Status
Withdrawn
Last Updated
8 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 12, 2023
End Date
July 24, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lauren Ng, PhD

Principal Investigator

University of California, Los Angeles

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

Outcomes

Primary Outcomes

Intervention Engagement

Time Frame: post treatment, average 1 month after enrollment

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

Intervention Implementation

Time Frame: post treatment, average 1 month after enrollment

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

Change in PTSD Knowledge

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Change in PTSD Symptoms(Day 0 baseline, 1 month follow-up)
  • Change in Functional Impairment(Day 0 baseline, 1 month follow-up)
  • Change in Anxiety Symptoms(Day 0 baseline, 1 month follow-up)
  • Change in Substance Use(Day 0 baseline, 1 month follow-up)
  • Change in Depression Symptoms(Day 0 baseline, 1 month follow-up)
  • Change in Trauma Symptoms(Day 0 baseline, 1 month follow-up)

Study Sites (1)

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