Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness

NCT ID: NCT06311188

Last Updated: 2025-12-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-30
• Study Completion Date: 2026-01-31

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.

Detailed Description

This study was conceptualized via an initial partnership with the Principal Investigator (PI), the City of Columbus Commission on Black Girls (Commission or COBG) and the Franklin County Juvenile Court. The investigators will also conduct individual semi-structured interviews with providers (N=20) to assess their views of the adapted intervention, as well as who they think will be best to deliver the intervention, and in which settings/locations. Further, the investigators will create three advisory boards: Community Advisory Board, Scientific Advisory Board, and a Youth Advisory Board to assist the research team with recruitment, study design and implementation, intervention development, and to ensure the rigor and translational aspects of the research study. The investigators will use all the identified themes from the JI BAFA, P/C, and provider interviews to adapt and test a healing centered stress reduction intervention for Phase II of the study. The investigators will recruit JI BAFA-P/C dyads for Phase II of the study and Phase I participants will be invited to participate.

The objectives of this research study are to:

1. Assess JI BAFAs' PTSD, as well as their and their P/Cs' stress.

2. Culturally adapt a healing centered stress reduction intervention based on the responses from ten JI BAFA-P/C dyads, including ten Black girls ages 14-18 who are involved with the Franklin County Juvenile Court and ten of their parents/caregivers based on their feedback to identify specific gaps in service provision and utilization of services, i.e. barriers to treatment, as well as describe the proposed intervention and elicit their feedback about its utility and implementation. Intervention development and adaptation will also be based on the feedback from 20 providers, and recommendations from select advisory board members.

3. Test the culturally adapted intervention and assess the participants' experiences via member checking, a method used to ensure the accuracy of what they told us in the interviews at the end of the interview.

4. Identify specific gaps in service provision and utilization of services.

5. Provide recommendations to study participants and Franklin County Juvenile Court to inform practice protocols, and a future randomized control trial to test this culturally adapted intervention with a larger sample of participants.

Conditions

Stress; Trauma; PTSD; HPA

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ITR Healing Intervention

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

Group Type: EXPERIMENTAL

ITR Healing intervention

Intervention Type: 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.

Interventions

ITR Healing intervention

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Minority Health and Health Disparities (NIMHD)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Camille Renee' Quinn

Associate Professor of Social Work, School of Social Work

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephanie Power-Carter, PhD

Role: STUDY_DIRECTOR

Ohio State University

Central Contacts

Camille R Quinn, PhD

Role: CONTACT

Phone: 13122030969

Email: crquinn@umich.edu

Michael Kloc, MSW

Role: CONTACT

Email: mkloc@umich.edu

Other Identifiers

1R21MD016940-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00240243

Identifier Type: -

Identifier Source: org_study_id