The Impact of a School-Based, Trauma-Informed CBT Intervention for Young Women

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03376633
• Other study ID #: IRB17-0585
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Behavioral Symptoms
• Depression
• Disease
• Mental Disorders
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Trauma and Stressor Related Disorders
• Wounds and Injuries

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