AnxietyNCT03376633
The Impact of a School-Based, Trauma-Informed CBT Intervention for Young Women
A study testing Working on Womanhood (WOW) in people with Anxiety and Anxiety Disorders, run by University of Chicago at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Anxiety, Anxiety Disorders, Behavioral Symptoms
- What is being tested?
- Working on Womanhood (WOW)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,106 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2017to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
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.
- Conditions
- Anxiety, Anxiety Disorders, Behavioral Symptoms, Depression, Mental Disorders, Stress Disorders, Post-Traumatic
- Being tested
- Working on Womanhood (WOW)
- 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
- Medical subject headings
- Anxiety Disorders, Behavioral Symptoms, Depression, Mental Disorders, Stress Disorders, Post-Traumatic, Stress Disorders, Traumatic, Trauma and Stressor Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Working on Womanhood (WOW)Behavioural
A trauma-informed group counseling and clinical mentoring intervention for young women
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | 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. |
| WOW Group and Individual Counseling | Experimental | 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. Receives: Behavioral: Working on Womanhood (WOW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Up to 36 months
Change in post-traumatic stress disorder (PTSD) assessment score
Score on self-reported PTSD screen, obtained from the Child and Adolescent Trauma Screen (CATS)
Measured: Up to 36 months
Change in anxiety assessment score
Score on self-reported anxiety screen, obtained from the BASC-3 SRP
Measured: Up to 36 months
Secondary outcomes (8)
Change in high school graduation
On-time graduation rate, obtained from Chicago Public Schools (CPS) administrative database
Measured: Up to 5 years
Change in absences
Rate and number of school absences, obtained from CPS administrative database
Measured: 1-year, 2-year, 3-year, 4-year, 5-year
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
Measured: 1-year, 2-year, 3-year, 4-year, 5-year
Change in student misconduct
Number of in-school and out-of-school suspensions, obtained from CPS administrative database
Measured: 1-year, 2-year, 3-year, 4-year, 5-year
Change in course failures
Rate and number of courses failed, obtained from CPS administrative database
Measured: 1-year, 2-year, 3-year, 4-year, 5-year
Change in overall arrests
Number of total arrests, obtained from Chicago Police Department (CPD) and Illinois State Police (ISP) administrative databases
Measured: 1-year, 2-year, 3-year, 4-year, 5-year
Change in violent crime arrests
Number of arrests for violent crimes, obtained from CPD and ISP administrative databases
Measured: 1-year, 2-year, 3-year, 4-year, 5-year
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
Measured: 1-year, 2-year, 3-year, 4-year, 5-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start1 Oct 2017
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376633
- Sponsor's protocol ID
- IRB17-0585
- Status last verified
- Aug 2022
- First submitted
- 4 Dec 2017
- Last updated
- 24 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Promise of a School-Based, Trauma-Informed Cognitive Behavioral Therapy Intervention for Young Women in Chicago: A Randomized Evaluation
- ClinicalTrials.gov ID
- NCT03376633
- Acronym / sponsor ID
- IRB17-0585
- Conditions
- Anxiety, Anxiety Disorders, Behavioral Symptoms, Depression, Mental Disorders, Stress Disorders, Post-Traumatic
- Keywords
- Randomized Controlled Trial, RCT, Chicago Public Schools, high school, trauma-informed counseling, group-based counseling, counseling, mentoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,106 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- 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
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –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. |
| WOW Group and Individual Counseling | Experimental | Behavioral: Working on Womanhood (WOW)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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Working on Womanhood (WOW)A trauma-informed group counseling and clinical mentoring intervention for young women | Behavioural | WOW Group and Individual Counseling |
Primary outcome
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)
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)
Change in anxiety assessment score
Time frame: Up to 36 months
Score on self-reported anxiety screen, obtained from the BASC-3 SRP
8 secondary outcomes
Change in high school graduation
Time frame: Up to 5 years
Change in absences
Time frame: 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
Change in student misconduct
Time frame: 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
Change in overall arrests
Time frame: 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
Change in other arrests (property, drug, and other)
Time frame: 1-year, 2-year, 3-year, 4-year, 5-year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Working on Womanhood (WOW) in people with Anxiety and Anxiety Disorders, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in depression assessment score (time frame: Up to 36 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2022.