Adaptation of the PCIP for Spanish Speaking Adolescents and Families

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05899322
• Other study ID #: #22-001744
• Status: Enrolling by invitation
• Phase: N/A
• Start date: June 12, 2023
• Est. completion date: August 15, 2025

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: August 15, 2025
• Est. primary completion date: April 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 22 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Behavioral:
• Primary Care Intervention for PTSD Spanish Speaking Adolescents
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.
• Waitlist Treatment as Usual
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.

Locations

Country	Name	City	State
United States	University of California Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Intervention Engagement	Data will be collected regarding participant completion of therapy, no show rates, and attendance.	post treatment, average 1 month after enrollment
Primary	Intervention Implementation	Study therapists will complete qualitative interviews regarding intervention delivery feasibility and study protocols.	post treatment, average 1 month after enrollment
Secondary	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	Day 0 baseline, 1 month follow-up
Secondary	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).	Day 0 baseline, 1 month follow-up
Secondary	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)	Day 0 baseline, 1 month follow-up
Secondary	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).	Day 0 baseline, 1 month follow-up
Secondary	Change in Functional Impairment	Changes in functional impairment measured by The Columbia Impairment Scale (C.I.S.; 0-52, Higher scores indicate greater impairment).	Day 0 baseline, 1 month follow-up
Secondary	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).	Day 0 baseline, 1 month follow-up