Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness

NCT06311188 | Not Yet Recruiting

• 2 other identifiers: HUM002402431R21MD016940-01A1
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to investigate justice-involved Black/African American female adolescents' (JI BAFAs; N=35) self-reported outcomes: stress, posttraumatic stress disorder (PTSD), recidivism, etc., as well as their parents/caregivers' (P/Cs; N=35) stress and pre- and post- intervention results along with their views of an adapted intervention.

Conditions

Stress; Trauma; PTSD; HPA

Keywords

Nonrandomized trial; Black girls; Legal system involvement; Cortisol Biomarker

Outcome Measures

Primary Outcomes (2)

• PTSD Screen

  PTSD psychiatric disorder that may occur in people who have experienced or witnessed a traumatic event such as a natural disaster, a serious accident, a terrorist act, war/combat, or rape or who have been threatened with death, sexual violence or serious injury. PTSD Will be measured by the Primary Care PTSD Screen, which all participants will complete. . The authors suggest that in most circumstances the results of the PC-PTSD should Those screening positive should then be assessed with a structured interview for PTSD. The screen does not include a list of potentially traumatic events.

  24 months

• PTSD Checklist

  PTSD Checklist from DSM-5 (PCL-5), which all participants will complete. A total symptom severity score (range - 0-80) can be obtained by summing the scores for each of the 20 items.

  24 months

Secondary Outcomes (8)

• Stress Psychosocial

  24 months

• Stress Physiological

  24 months

• Parent/Caregiver-Child Relationship

  24 months

• Five Facet Mindfulness Questionnaire (FFMQ)

  24 months

• Recidivism

  24 months

Other Outcomes (2)

• MoCA screen

  20 months

• CESD - Depression screen

  20 months

Study Arms (1)

ITR Healing Intervention

EXPERIMENTAL

This is a single arm nonrandomized test of the culturally adapted ITR healing intervention.

Behavioral: ITR Healing intervention

Interventions

ITR Healing intervention BEHAVIORAL

This is a nonrandomized test of the culturally adapted ITR healing intervention that is based on the ITR framework. The ITR Healing intervention comprises six 60-minute sessions based on Intersectionality theoretical framework, Healing Centered Engagement (HCE) activities that were integrated into the intervention, as well as participant's feedback about the intervention. Also, the participants' behavioral experiences per the Theoretical Domains Framework targets was used to adapt the intervention activities. HCE focuses on building a holistic approach and empathy for each session, i.e., using music, dance/movement, meditation, breathing and journaling.

ITR Healing Intervention

Eligibility Criteria

• Age: 14 Years - 90 Years
• Gender Eligibility Details: Participant eligibility is based on self representation and self disclosure of their gender.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Black girls aged 14-18
• Black girls with a misdemeanor and/or felony charge in their lifetime
• Positive PTSD screen (PC-PTSD score of 2 or more; if more than one JI BAFA are from the same family, the investigators will recruit the girl with the highest PTSD score)
• Black girls report juvenile justice involvement within 12 months prior
• Black girls live with a P/C (mothers, fathers, and other caregivers/legal guardians) who will also participate in the study
• Parents/Caregivers nominated by the girls to participate in the study who are between the ages of 18 and 90 years of age
• Legal/ social services providers / educators who work with the population.

You may not qualify if:

• Prisoners per the IRB definition
• Black girls who are younger than 14 and older than 18
• Severe cognitive delay so the youth cannot complete the assessment instruments, as measured using the Montreal Cognitive Assessment (MoCA)
• Active psychosis requiring a greater level of care \[Structured Clinical Interview for DSM Disorders (SCID)\]. Screening for the study will take place prior to consent/assent of the study participants
• Parents/Caregivers who are not nominated by the girls to participate in the study who are not between the ages of 18 and 90 years of age
• Legal/ social services providers / educators who have been working with the population for less than three years.

Sponsors & Collaborators

• University of Michigan: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator

MeSH Terms

Conditions

Wounds and Injuries; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

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

Study Officials

• Stephanie Power-Carter, PhD

  Ohio State University

  STUDY DIRECTOR

Central Study Contacts

Camille R Quinn, PhD

CONTACT

13122030969; crquinn@umich.edu

Michael Kloc, MSW

CONTACT

mkloc@umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Social Work, School of Social Work

Model Details: Single arm trial

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 15, 2024
• Study Start: April 8, 2026
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): January 31, 2027
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The investigators agree to deposit data into ICPSR repository as soon as possible but no later than within one year of the completion of the funded project period for the parent award or upon acceptance of the data for publication, or public disclosure of a submitted patent application, whichever is earlier.
• Access Criteria: Members of ICPSR will be able to access our deidentified data per their eligibility requirements.