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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03376633
Other study ID # IRB17-0585
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2017
Est. completion date November 30, 2021

Study information

Verified date August 2022
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The University of Chicago Crime Lab and Education Lab are partnering with the City of Chicago, Chicago Public Schools, and Youth Guidance to implement a randomized controlled trial to test the efficacy of Youth Guidance's Working on Womanhood program across two cohorts: Cohort 1, receiving programming during academic years 2017-18 and 2018-19, and Cohort 2, receiving programming during academic years 2018-19 and 2019-20. For Cohort 1, incoming 9th, 10th, and 11th grade female students in 10 Chicago Public Schools high schools (as of Fall 2017) will be screened for eligibility and randomized to either a treatment group that will be offered to receive WOW services over two academic years, or to a control group that will not be offered to receive WOW services over two academic years. For cohort 2, only incoming 9th graders (as of Fall 2018) will be randomized, in the same manner. Control group students will still be eligible to receive other status quo school and community supports. Outcomes of interest will be measured using administrative data and a comprehensive student survey. WOW is a trauma-informed, in-school group counseling and clinical mentoring program developed by non-profit Youth Guidance. Informed by CBT, WOW helps girls challenge unhelpful thoughts and build self-esteem and self-efficacy to make positive and healthy decisions. WOW aims to reduce depression, anxiety, and PTSD symptoms, and improve academic and behavioral outcomes. WOW delivers a 26-lesson curriculum via weekly small-group counseling sessions during the school day. The curriculum is designed around five core values: self-awareness, emotional intelligence, healthy relationships, visionary goal setting, and leadership, and delivered by masters-level social workers and counselors. WOW counselors may also provide individual counseling and referrals to other services. The WOW program fills a critical gap in the existing set of programs available to these students, by providing services that cater to the unique needs of young women in our most under-resourced high schools.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Working on Womanhood (WOW)
A trauma-informed group counseling and clinical mentoring intervention for young women

Locations

Country Name City State
United States University of Chicago Chicago Illinois

Sponsors (11)

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

Country where clinical trial is conducted

United States, 

Outcome

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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