Adaptation and Translation of the Primary Care Intervention for PTSD for Spanish Speaking Adolescents and Families
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Intervention Acceptability
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 12 Years to 22 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Primary Care Intervention for PTSD (PCIP) Spanish Speaking Adolescents and Families
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.
Intervention: Primary Care Intervention for PTSD Spanish Speaking Adolescents (Behavioral)
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.
Intervention: Waitlist Treatment as Usual (Behavioral)
Outcomes
Primary Outcomes
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.
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)
Secondary Outcomes
- Change in Trauma Symptoms(Day 0 baseline, 1 month follow-up)
- 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)
Investigators
Lauren Ng, PhD
Principal Investigator
University of California, Los Angeles