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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05966831
Other study ID # HUM00234352
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 1, 2023
Est. completion date January 10, 2025

Study information

Verified date August 2023
Source University of Michigan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is a randomized controlled trial (RCT) that assesses the effectiveness of a metacognitive self-control training intervention (MCT) in conjunction with virtual-reality job interview training (VR-JIT) in a sample of formerly incarcerated individuals. The study also includes an implementation evaluation.


Description:

The goal is to conduct a randomized controlled trial (RCT) that assesses the effectiveness of a metacognitive self-control training intervention (MCT) in conjunction with virtual-reality job interview training (VR-JIT) in a sample of formerly incarcerated individuals, as well as complete an implementation evaluation. Participants will be recruited who who: 1) have previously been incarcerated (e.g., jail, prison), 2) have reentered society, 3) 18 years of age or older, 4) currently are a part of the A Brighter Way program. A Brighter Way is a local re-entry program in Ypsilanti, Michigan (MI) that focuses on helping formerly incarcerated individuals (living in Washtenaw county) build stable and successful lives. Participants will be randomly assigned to conditions where they either receive both MCT and VR-JIT interventions, or where they receive an Active-Control Activity and VR-JIT intervention (with an allocation ratio of 1:1). To assess the effectiveness of MCT, researchers plan to compare behavioral and self-report measures of self-control pre and post interventions, as well as assess employment and recidivism outcomes.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 40
Est. completion date January 10, 2025
Est. primary completion date October 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years or older - Actively enrolled in A Brighter Way Program - 3rd grade reading level or higher Exclusion Criteria: - Has uncorrected hearing or visual problem that prevents them from using the training

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Metacognitive Self-Control Training (MCT)
Metacognitive Self-Control Training (MCT) was originally developed by the Michigan Skills Project for students in middle/high school. The MCT training intervention has been updated to be suitable for adults. MCT is a lecture style intervention that encompasses 13 modules (over the course of 4 weeks) on improving self-control that is to be delivered in a community setting. Across the training, participants will learn new "tools" for improving self-control.
Virtual Reality Job Interview Training (VR-JIT)
VR-JIT provides trainees with an opportunity to repeatedly practice interviewing for a job at fictional company 'Wondersmart'. Prior to interviewing, trainees review self-guided e-learning materials on how to find, prepare for, succeed in, and follow-up on job interviews that includes the review of 10 job interview skills. Trainees also complete an online job application for one of 14 jobs (e.g., cashier, clerical, customer service, food services, inventory, janitorial, web developer) that informs the virtual interview experience.

Locations

Country Name City State
United States University of Michigan Ann Arbor Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Self-Control Measured by Brief Self-Control Scale (BSCS) The measure is a Likert Scale style questionnaire. 13 items are scored from 1 (not at all) to 5 (Very much). The total score is calculated from adding all items together and higher scores indicate higher levels of self-control. Baseline and posttest (approximately 8 weeks after baseline)
Primary Change in Self-Control Measured by Barratt Impulsiveness Scale The measure is a Likert Scale style questionnaire. 30 items are scored from 1 (Rarely/Never) to 4 (Almost Always/Always). The total score is calculated from adding all items together and range from 30 to 120; higher scores indicate higher levels of impulsiveness. Baseline and posttest (approximately 8 weeks after baseline)
Primary Change in Self-Control Measured by Short Form Self-Regulation Questionnaire The measure is a Likert Scale style questionnaire. 31 items are scored from 1 (Strongly Disagree) to 5 (Strongly Agree). The total score is calculated from adding all items together. Higher scores indicate higher self-regulation capacity. Baseline and posttest (approximately 8 weeks after baseline)
Primary Change in Adult Attention Deficit/Hyperactivity Disorder (ADHD) Symptomology measured by ADHD Self-Report Scale (ASRS) The Adult ADHD Self-Report Scale (ASRS) is an instrument consisting of the eighteen Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV TR) criteria. Six of the eighteen questions were found to be the most predictive of symptoms consistent with ADHD. These six questions are the basis for the ASRS v1.1 Screener and are also Part A of the Symptom Checklist. Part B of the Symptom Checklist contains the remaining twelve questions. All questions utilize a Likert scale from Never, Rarely, Sometimes, Often, to Very Often. Baseline and posttest (approximately 8 weeks after baseline)
Primary Change in Adult Attention Deficit/Hyperactivity Disorder (ADHD) Symptomology measured by the Structured Clinical Interview (SCID-RV) for The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) The Structured Clinical Interview (SCID-RV) for DSM-5 for Adult Attention-Deficit/Hyperactivity Disorder measures ADHD symptomology. The module is made up of 5 major criteria with items in each criteria using a 3 point Likert scale ranging from 1 "absent or False" to 3 "threshold or true". This module uses a dichotomous scoring method that indexes whether a symptom is present or not. Only responses of "threshold or true" are coded as symptom present, while responses of "subthreshold" or "absent or false" are coded as symptom absent, so each individual will have a score of symptom absent = 0, and symptom present = 1 for criteria A through E. Baseline and posttest (approximately 8 weeks after baseline)
Primary Change in Employment Outcome Employment survey indicating that participants are either employed (1) or unemployed (0). Baseline and 9 Month Follow Up (9 Months after randomization)
Secondary Change in Recidivism Researchers will track if a participant becomes re-incarcerated throughout the entire study. This will be marked as Yes (1) or No (0) in our database tracking. Baseline and throughout 9 Month Follow Up (9 Months after randomization)
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