ClinicalTrials.gg
CompletedNCT03376633Updated Aug 24, 2022

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

An interventional study of Working on Womanhood (WOW) in Anxiety, Anxiety Disorders and Behavioral Symptoms, sponsored by University of Chicago. Completed at 1 site in United States. Open to female participants. Per ClinicalTrials.gov, last updated 2022-08-24.

Sponsored by University of Chicago · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
5,106
Allocation
Randomized
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 2,266 studies in Anxiety Disorders with a site in United States — 397 open to participants now, 504 under way, 13 of them phase 3. Anxiety Disorders · United States.

Enrollment
13th of 2,042
5,106 · median 69
Started
2017
with 95 others
No phase
1,607 of 2,266
294 open now
Registered
851st of 2,266
by date

Among the 2,266 studies in Anxiety Disorders with a site in United States, this one is the 13th largest by enrollment of the 2,042 interventional ones that give a count, is one of 96 that started in 2017, is one of 1,607 with no phase, and was the 851st registered.

Anxiety Disorders

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

Browse Anxiety Disorders studies →

Open to participants now

397 of the 2,266 studies in Anxiety Disorders with a site in United States are open now. Recruiting first, the newest first:

392 more — sign in →

All 397 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 943 Anxiety Disorders studies recruiting now, 416 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 232 take children under 18; 316 take healthy volunteers.

This study: female · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 2,266 studies in Anxiety Disorders with a site in United States, or all of them as a file.
02

Study 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.
Read the 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.

03

Conditions studied

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

Keywords

  • Randomized Controlled Trial
  • RCT
  • Chicago Public Schools
  • high school
  • trauma-informed counseling
  • group-based counseling
  • counseling
  • mentoring
  • Cognitive Behavioral Therapy
  • CBT
  • adolescents
  • females
  • trauma
  • stress
  • PTSD
  • anxiety
  • depression
  • graduation
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
5,106 participants (actual)

Study arms

  • 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.

    Behavioral: Working on Womanhood (WOW)

Interventions

  • BehavioralWorking on Womanhood (WOW)

    A trauma-informed group counseling and clinical mentoring intervention for young women

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: Up to 36 months

  2. Change in post-traumatic stress disorder (PTSD) assessment score

    Score on self-reported PTSD screen, obtained from the Child and Adolescent Trauma Screen (CATS)

    Time frame: Up to 36 months

  3. Change in anxiety assessment score

    Score on self-reported anxiety screen, obtained from the BASC-3 SRP

    Time frame: Up to 36 months

Secondary outcomes

  1. Change in high school graduation

    On-time graduation rate, obtained from Chicago Public Schools (CPS) administrative database

    Time frame: Up to 5 years

  2. Change in absences

    Rate and number of school absences, obtained from CPS administrative database

    Time frame: 1-year, 2-year, 3-year, 4-year, 5-year

  3. 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

    Time frame: 1-year, 2-year, 3-year, 4-year, 5-year

  4. Change in student misconduct

    Number of in-school and out-of-school suspensions, obtained from CPS administrative database

    Time frame: 1-year, 2-year, 3-year, 4-year, 5-year

  5. Change in course failures

    Rate and number of courses failed, obtained from CPS administrative database

    Time frame: 1-year, 2-year, 3-year, 4-year, 5-year

  6. Change in overall arrests

    Number of total arrests, obtained from Chicago Police Department (CPD) and Illinois State Police (ISP) administrative databases

    Time frame: 1-year, 2-year, 3-year, 4-year, 5-year

  7. Change in violent crime arrests

    Number of arrests for violent crimes, obtained from CPD and ISP administrative databases

    Time frame: 1-year, 2-year, 3-year, 4-year, 5-year

  8. 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

    Time frame: 1-year, 2-year, 3-year, 4-year, 5-year

Other outcomes

  1. 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

    Time frame: 1-year, 2-year, 3-year, 4-year, 5-year

  2. Change in sexual health and behaviors

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  3. Change in substance use

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  4. Change in school attitudes and engagement

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  5. Change in family cohesion

    Measures adapted from the Family Environment Scale (relationships section), obtained from representative student survey

    Time frame: Up to 36 months

  6. Change in self-esteem (self-reliance, sense of inadequacy)

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  7. Change in emotional regulation

    Score on the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF), obtained from representative student survey

    Time frame: Up to 36 months

  8. 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

    Time frame: Up to 36 months

  9. Change in peer aggression

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  10. Change in somatization

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  11. Change in attention problems (hyperactivity)

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  12. Change in interpersonal relationships

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  13. Change in locus of control and anger management

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  14. Change in empowerment

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  15. Change in self-concept

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  16. Change in social supports

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

  17. Change in perception of racial / cultural identity

    Self-reported survey measures, obtained from representative student survey

    Time frame: Up to 36 months

07

Study locations

1 site
  • University of Chicago
    Chicago, Illinois 60602, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2017 to primary completion in Nov 2021, 49 months.

Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 49 months is above that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 4, 2017
First posted
Dec 18, 2017
StartActual
Oct 1, 2017
Primary completionActual
Nov 30, 2021
CompletionActual
Nov 30, 2021
Last update
Aug 24, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03376633
Collaborators
Northwestern University, Youth Guidance, Chicago Public Schools, U.S. Department of Justice, Paul M. Angell Family Foundation, Polk Bros. Foundation, The Reva & David Logan Foundation, DePaul University, Laura and John Arnold Foundation, MacArthur Foundation
Responsible party
Sponsor
First posted
Dec 18, 2017
Start date
Oct 1, 2017
Primary completion
Nov 30, 2021
Completion
Nov 30, 2021
Last update
Aug 24, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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