Clinical trial NCT03376633: 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
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Northwestern University
name: Youth Guidance
name: Chicago Public Schools
name: U.S. Department of Justice
name: Paul M. Angell Family Foundation
name: Polk Bros. Foundation
name: The Reva & David Logan Foundation
name: DePaul University
name: Laura and John Arnold Foundation
name: MacArthur Foundation
First posted: 2017-12-18
Enrollment: 5106
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Change in depression assessment score
timeFrame: Up to 36 months
measure: Change in post-traumatic stress disorder (PTSD) assessment score
timeFrame: Up to 36 months
measure: Change in anxiety assessment score
timeFrame: Up to 36 months
Secondary outcomes:
measure: Change in high school graduation
timeFrame: Up to 5 years
measure: Change in absences
timeFrame: 1-year, 2-year, 3-year, 4-year, 5-year
measure: Change in index of CPS schooling outcomes
timeFrame: 1-year, 2-year, 3-year, 4-year, 5-year
measure: Change in student misconduct
timeFrame: 1-year, 2-year, 3-year, 4-year, 5-year
measure: Change in course failures
timeFrame: 1-year, 2-year, 3-year, 4-year, 5-year
measure: Change in overall arrests
timeFrame: 1-year, 2-year, 3-year, 4-year, 5-year
measure: Change in violent crime arrests
timeFrame: 1-year, 2-year, 3-year, 4-year, 5-year
measure: Change in other arrests (property, drug, and other)
timeFrame: 1-year, 2-year, 3-year, 4-year, 5-year
Other outcomes:
measure: Change in pregnancy/childbirth rate
timeFrame: 1-year, 2-year, 3-year, 4-year, 5-year
measure: Change in sexual health and behaviors
timeFrame: Up to 36 months
measure: Change in substance use
timeFrame: Up to 36 months
measure: Change in school attitudes and engagement
timeFrame: Up to 36 months
measure: Change in family cohesion
timeFrame: Up to 36 months
measure: Change in self-esteem (self-reliance, sense of inadequacy)
timeFrame: Up to 36 months
measure: Change in emotional regulation
timeFrame: Up to 36 months
measure: Change in decision-making (self-efficacy, future orientation)
timeFrame: Up to 36 months
measure: Change in peer aggression
timeFrame: Up to 36 months
measure: Change in somatization
timeFrame: Up to 36 months
measure: Change in attention problems (hyperactivity)
timeFrame: Up to 36 months
measure: Change in interpersonal relationships
timeFrame: Up to 36 months
measure: Change in locus of control and anger management
timeFrame: Up to 36 months
measure: Change in empowerment
timeFrame: Up to 36 months
measure: Change in self-concept
timeFrame: Up to 36 months
measure: Change in social supports
timeFrame: Up to 36 months
measure: Change in perception of racial / cultural identity
timeFrame: Up to 36 months
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References: