Exploring PTSD Symptoms, Barriers and Facilitators to Mindfulness

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14-90
SponsorUniversity of Michigan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: ITR Healing InterventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
24 months
2

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.

Time frame
24 months

Secondary outcomes

1

Stress Psychosocial

Perceived Stress Scale Questionnaire-short, 10 items. Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

Time frame
24 months
2

Stress Physiological

Hair assessment and provide 1-3 cm of hair will be assessed via enzyme-linked immunosorbent assay at the Ford Stress Science Lab for mean cortisol. Hair will be cut from the posterior vertex of the scalp. Ideally participants will have 3 cm of hair for assay but if they have 1 cm will be included to avoid selection bias; hair length can be included as a covariate in analysis if needed. Participants will be screened on hair care practices (chemical use, shampoo frequency), medications (steroids, estrogen/progesterone) to assess the effect on cortisol. The hair cortisol captures cumulative exposure to cortisol over time as each 1 cm of hair growth approximates 1 month of mean cortisol output.

Time frame
24 months
3

Parent/Caregiver-Child Relationship

All participants will complete a 4-item Parent/Caregiver-Child Relationship Scale to assess the quality of their relationships. These items will be reverse scored so that a lower score indicates less of a relationship and a higher score indicates more of a relationship.

Time frame
24 months
4

Five Facet Mindfulness Questionnaire (FFMQ)

FFMQ assesses actions, non-judgmental inner experience, and non-reactivity. Direct Scoring with Likert values and higher scores are indicative of someone who is more mindful in their everyday life.

Time frame
24 months

Other outcomes

1

MoCA screen

Everyone interested in participating in the study will complete the Montreal Cognitive Assessment - one of three screeners for study eligibility. The maximum score is 30 and the minimum score is 1.

Time frame
20 months
2

CESD - Depression screen

Everyone interested in participating in the study will complete the Center for Epidemiologic Studies Depression Scale to screen for depression, wth internal consistency = .85-.90. MBSR has been effectively modified for depressed individuals.

Time frame
20 months

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: