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Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness

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University of Michigan

Status

Not yet enrolling

Conditions

HPA
PTSD
Trauma
Stress

Treatments

Behavioral: ITR Healing intervention

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06311188
HUM00240243
1R21MD016940-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 estimated patients

Sex

All

Ages

14 to 90 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

90 participants in 1 patient group

ITR Healing Intervention
Experimental group
Description:
This is a single arm nonrandomized test of the culturally adapted ITR healing intervention.
Treatment:
Behavioral: ITR Healing intervention

Trial contacts and locations

0

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Central trial contact

Camille R Quinn, PhD; Michael Kloc, MSW

Data sourced from clinicaltrials.gov

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