- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03376633
The Impact of a School-Based, Trauma-Informed CBT Intervention for Young Women
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:
- 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.
- To evaluate the cost-effectiveness of the WOW program.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60602
- University of Chicago
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Genders Eligible for Study
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
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
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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
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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
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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
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1-year, 2-year, 3-year, 4-year, 5-year
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Change in other arrests (property, drug, and other)
Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year
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Number of non-violent crime arrests, including property crimes, drug crimes, and other crimes, obtained from CPD and ISP administrative databases
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1-year, 2-year, 3-year, 4-year, 5-year
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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
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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
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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
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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
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Up to 36 months
|
Change in emotional regulation
Time Frame: Up to 36 months
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Score on the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF), obtained from representative student survey
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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
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Up to 36 months
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Change in peer aggression
Time Frame: Up to 36 months
|
Self-reported survey measures, obtained from representative student survey
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Up to 36 months
|
Change in somatization
Time Frame: Up to 36 months
|
Self-reported survey measures, obtained from representative student survey
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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
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB17-0585
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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