Clinical trial NCT06311188: Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness
Official title: Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness-based Stress Reduction for Justice-Involved Black/African American Female Adolescents and Parents/Caregivers
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Trauma
PTSD
HPA
Keywords: Nonrandomized trial
Black girls
Legal system involvement
Cortisol Biomarker
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2024-03-15
Enrollment: 90
Sex: ALL
Minimum age (years): 14
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm trial
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: PTSD Screen
timeFrame: 24 months
measure: PTSD Checklist
timeFrame: 24 months
Secondary outcomes:
measure: Stress Psychosocial
timeFrame: 24 months
measure: Stress Physiological
timeFrame: 24 months
measure: Parent/Caregiver-Child Relationship
timeFrame: 24 months
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: 24 months
measure: Recidivism
timeFrame: 24 months
measure: Personal Agency
timeFrame: 24 months
measure: Racial Identity
timeFrame: 24 months
measure: Parenting Stress
timeFrame: 24 months
Other outcomes:
measure: MoCA screen
timeFrame: 20 months
measure: CESD - Depression screen
timeFrame: 20 months
Locations:
Study officials:
affiliation: Ohio State University
name: Stephanie Power-Carter, PhD
role: STUDY_DIRECTOR
References: