Depression Clinical Trial
Official title:
The Promise of a School-Based, Trauma-Informed Cognitive Behavioral Therapy Intervention for Young Women in Chicago: A Randomized Evaluation
Verified date | August 2022 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is: 1. To conduct a randomized controlled trial to evaluate the impact of Working on Womanhood (WOW), a school-based, trauma-informed counseling and clinical mentoring program for young women in Chicago, on PTSD, anxiety, depression. In addition, this study will examine the effect of WOW on other, secondary outcomes such as school discipline, GPA, high school graduation, and criminal justice involvement, risky behaviors, and other social-emotional learning outcomes. 2. To evaluate the cost-effectiveness of the WOW program.
Status | Completed |
Enrollment | 5106 |
Est. completion date | November 30, 2021 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Chicago Public Schools high schools, chosen in collaboration with Youth Guidance leadership, that serve majority low-income, minority students in community areas impacted by violence - School's 9th, 10th, and 11th grade female student population is large enough to support at least 50 treatment students and 50 control students, after accounting for a 60 to 70 percent take-up rate and exclusion criteria - Schools do not currently have WOW services (as of AY2016-17) - School administrators are enthusiastic about the program and agree to the terms and conditions of the experimental design - All female students in these selected schools entering 9th, 10th, or 11th grade in Fall 2017, or entering 9th grade in Fall 2018. Exclusion Criteria: - Students with an overall attendance rate below 75% during AY2016-17 [Cohort 1] or AY2017-18 [Cohort 2] - Students who display proactive aggression towards others - Students with severe cognitive / developmental disabilities, these include: autistic, emotional and behavior disorder, educable mental handicap, intellectual disability - profound, severe/profound handicap, and trainable mental handicap |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago | Chicago Public Schools, DePaul University, Laura and John Arnold Foundation, MacArthur Foundation, Northwestern University, Paul M. Angell Family Foundation, Polk Bros. Foundation, The Reva & David Logan Foundation, U.S. Department of Justice, Youth Guidance |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in pregnancy/childbirth rate | Self-reported survey measures, obtained from representative student survey; Childbirth data, obtained from the Chicago and Illinois Dept. of Public Health | 1-year, 2-year, 3-year, 4-year, 5-year | |
Other | Change in sexual health and behaviors | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in substance use | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in school attitudes and engagement | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in family cohesion | Measures adapted from the Family Environment Scale (relationships section), obtained from representative student survey | Up to 36 months | |
Other | Change in self-esteem (self-reliance, sense of inadequacy) | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in emotional regulation | Score on the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF), obtained from representative student survey | Up to 36 months | |
Other | Change in decision-making (self-efficacy, future orientation) | Score on the ZIMBARDO time perspective survey, Life Orientation Test - Revised (LOT-R), and other measures, obtained from representative student survey | Up to 36 months | |
Other | Change in peer aggression | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in somatization | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in attention problems (hyperactivity) | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in interpersonal relationships | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in locus of control and anger management | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in empowerment | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in self-concept | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in social supports | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Other | Change in perception of racial / cultural identity | Self-reported survey measures, obtained from representative student survey | Up to 36 months | |
Primary | Change in depression assessment score | Score on self-reported depression screen, obtained from the Behavior Assessment System for Children, Third Edition (BASC-3) Self-Report of Personality (SRP) | Up to 36 months | |
Primary | Change in post-traumatic stress disorder (PTSD) assessment score | Score on self-reported PTSD screen, obtained from the Child and Adolescent Trauma Screen (CATS) | Up to 36 months | |
Primary | Change in anxiety assessment score | Score on self-reported anxiety screen, obtained from the BASC-3 SRP | Up to 36 months | |
Secondary | Change in high school graduation | On-time graduation rate, obtained from Chicago Public Schools (CPS) administrative database | Up to 5 years | |
Secondary | Change in absences | Rate and number of school absences, obtained from CPS administrative database | 1-year, 2-year, 3-year, 4-year, 5-year | |
Secondary | Change in index of CPS schooling outcomes | Standardized index composed of GPA, number of course failures, attendance rate, and number of in-school and out-of-school suspensions, obtained from CPS administrative database | 1-year, 2-year, 3-year, 4-year, 5-year | |
Secondary | Change in student misconduct | Number of in-school and out-of-school suspensions, obtained from CPS administrative database | 1-year, 2-year, 3-year, 4-year, 5-year | |
Secondary | Change in course failures | Rate and number of courses failed, obtained from CPS administrative database | 1-year, 2-year, 3-year, 4-year, 5-year | |
Secondary | Change in overall arrests | Number of total arrests, obtained from Chicago Police Department (CPD) and Illinois State Police (ISP) administrative databases | 1-year, 2-year, 3-year, 4-year, 5-year | |
Secondary | Change in violent crime arrests | Number of arrests for violent crimes, obtained from CPD and ISP administrative databases | 1-year, 2-year, 3-year, 4-year, 5-year | |
Secondary | Change in other arrests (property, drug, and other) | Number of non-violent crime arrests, including property crimes, drug crimes, and other crimes, obtained from CPD and ISP administrative databases | 1-year, 2-year, 3-year, 4-year, 5-year |
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