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

Primary Purpose

Anxiety, Anxiety Disorders, Behavioral Symptoms

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Working on Womanhood (WOW)
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • University of Chicago

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

WOW Group and Individual Counseling

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)
Change in post-traumatic stress disorder (PTSD) assessment score
Score on self-reported PTSD screen, obtained from the Child and Adolescent Trauma Screen (CATS)
Change in anxiety assessment score
Score on self-reported anxiety screen, obtained from the BASC-3 SRP

Secondary Outcome Measures

Change in high school graduation
On-time graduation rate, obtained from Chicago Public Schools (CPS) administrative database
Change in absences
Rate and number of school absences, obtained from CPS administrative database
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
Change in student misconduct
Number of in-school and out-of-school suspensions, obtained from CPS administrative database
Change in course failures
Rate and number of courses failed, obtained from CPS administrative database
Change in overall arrests
Number of total arrests, obtained from Chicago Police Department (CPD) and Illinois State Police (ISP) administrative databases
Change in violent crime arrests
Number of arrests for violent crimes, obtained from CPD and ISP administrative databases
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

Full Information

First Posted
December 4, 2017
Last Updated
August 22, 2022
Sponsor
University of Chicago
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
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1. Study Identification

Unique Protocol Identification Number
NCT03376633
Brief Title
The Impact of a School-Based, Trauma-Informed CBT Intervention for Young Women
Official Title
The Promise of a School-Based, Trauma-Informed Cognitive Behavioral Therapy Intervention for Young Women in Chicago: A Randomized Evaluation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
November 30, 2021 (Actual)
Study Completion Date
November 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Treatment individuals will be provided information about the trial and consented into the study as part of WOW program materials (note: program participation is not conditional on participation in the research). Control individuals will not be provided information about the study, but may be provided information if they inquire about programming. Due to the intervention type, it is not possible to mask the identity of treatment participants from the provider or from participants. However, the provider will not be informed of the identity of the control group.
Allocation
Randomized
Enrollment
5106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
WOW Group and Individual Counseling
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Working on Womanhood (WOW)
Intervention Description
A trauma-informed group counseling and clinical mentoring intervention for young women
Primary Outcome Measure Information:
Title
Change in depression assessment score
Description
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
Title
Change in post-traumatic stress disorder (PTSD) assessment score
Description
Score on self-reported PTSD screen, obtained from the Child and Adolescent Trauma Screen (CATS)
Time Frame
Up to 36 months
Title
Change in anxiety assessment score
Description
Score on self-reported anxiety screen, obtained from the BASC-3 SRP
Time Frame
Up to 36 months
Secondary Outcome Measure Information:
Title
Change in high school graduation
Description
On-time graduation rate, obtained from Chicago Public Schools (CPS) administrative database
Time Frame
Up to 5 years
Title
Change in absences
Description
Rate and number of school absences, obtained from CPS administrative database
Time Frame
1-year, 2-year, 3-year, 4-year, 5-year
Title
Change in index of CPS schooling outcomes
Description
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
Title
Change in student misconduct
Description
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
Title
Change in course failures
Description
Rate and number of courses failed, obtained from CPS administrative database
Time Frame
1-year, 2-year, 3-year, 4-year, 5-year
Title
Change in overall arrests
Description
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
Title
Change in violent crime arrests
Description
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
Title
Change in other arrests (property, drug, and other)
Description
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 Pre-specified Outcome Measures:
Title
Change in pregnancy/childbirth rate
Description
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
Title
Change in sexual health and behaviors
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in substance use
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in school attitudes and engagement
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in family cohesion
Description
Measures adapted from the Family Environment Scale (relationships section), obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in self-esteem (self-reliance, sense of inadequacy)
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in emotional regulation
Description
Score on the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF), obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in decision-making (self-efficacy, future orientation)
Description
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
Title
Change in peer aggression
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in somatization
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in attention problems (hyperactivity)
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in interpersonal relationships
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in locus of control and anger management
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in empowerment
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in self-concept
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in social supports
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months
Title
Change in perception of racial / cultural identity
Description
Self-reported survey measures, obtained from representative student survey
Time Frame
Up to 36 months

10. Eligibility

Sex
Female
Gender Based
Yes
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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