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

August 22, 2022 updated by: University of Chicago

The Promise of a School-Based, Trauma-Informed Cognitive Behavioral Therapy Intervention for Young Women in Chicago: A Randomized Evaluation

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.

Study Overview

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

5106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Illinois
      • Chicago, Illinois, United States, 60602
        • University of Chicago

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control group
These youth will not receive Working on Womanhood (WOW) services during academic years 2017-18 and 2018-19 [Cohort 1] or 2018-19 and 2019-20 [Cohort 2] or after, and will not have contact with WOW clinicians. Control youth will be able to receive all other services available through their school as they normally would, such as access to the school counselor and after school programs.
EXPERIMENTAL: WOW Group and Individual Counseling
These youth will receive Working on Womanhood (WOW) services during academic years 2017-18 and 2018-19 [Cohort 1] or 2018-19 and 2019-20 [Cohort 2]. These young women will participate in weekly group therapy and skill-building sessions, led by master's level clinicians, and will also receive individual support and therapy from their clinicians as-needed.
A trauma-informed group counseling and clinical mentoring intervention for young women

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in depression assessment score
Time Frame: Up to 36 months
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
Change in post-traumatic stress disorder (PTSD) assessment score
Time Frame: Up to 36 months
Score on self-reported PTSD screen, obtained from the Child and Adolescent Trauma Screen (CATS)
Up to 36 months
Change in anxiety assessment score
Time Frame: Up to 36 months
Score on self-reported anxiety screen, obtained from the BASC-3 SRP
Up to 36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in high school graduation
Time Frame: Up to 5 years
On-time graduation rate, obtained from Chicago Public Schools (CPS) administrative database
Up to 5 years
Change in absences
Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year
Rate and number of school absences, obtained from CPS administrative database
1-year, 2-year, 3-year, 4-year, 5-year
Change in index of CPS schooling outcomes
Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year
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
Change in student misconduct
Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year
Number of in-school and out-of-school suspensions, obtained from CPS administrative database
1-year, 2-year, 3-year, 4-year, 5-year
Change in course failures
Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year
Rate and number of courses failed, obtained from CPS administrative database
1-year, 2-year, 3-year, 4-year, 5-year
Change in overall arrests
Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year
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
Change in violent crime arrests
Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year
Number of arrests for violent crimes, obtained from CPD and ISP administrative databases
1-year, 2-year, 3-year, 4-year, 5-year
Change in other arrests (property, drug, and other)
Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year
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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pregnancy/childbirth rate
Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year
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
Change in sexual health and behaviors
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in substance use
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in school attitudes and engagement
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in family cohesion
Time Frame: Up to 36 months
Measures adapted from the Family Environment Scale (relationships section), obtained from representative student survey
Up to 36 months
Change in self-esteem (self-reliance, sense of inadequacy)
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in emotional regulation
Time Frame: Up to 36 months
Score on the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF), obtained from representative student survey
Up to 36 months
Change in decision-making (self-efficacy, future orientation)
Time Frame: Up to 36 months
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
Change in peer aggression
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in somatization
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in attention problems (hyperactivity)
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in interpersonal relationships
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in locus of control and anger management
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in empowerment
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in self-concept
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in social supports
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months
Change in perception of racial / cultural identity
Time Frame: Up to 36 months
Self-reported survey measures, obtained from representative student survey
Up to 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ACTUAL)

November 30, 2021

Study Completion (ACTUAL)

November 30, 2021

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 12, 2017

First Posted (ACTUAL)

December 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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