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

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ClinicalTrials.gov Identifier: NCT03376633
Recruitment Status : Enrolling by invitation
First Posted : December 18, 2017
Last Update Posted : February 27, 2018
Sponsor:
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
Information provided by (Responsible Party):
University of Chicago

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.

Condition or disease Intervention/treatment Phase
Anxiety Anxiety Disorders Behavioral Symptoms Depression Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders Wounds and Injuries Behavioral: Working on Womanhood (WOW) Not Applicable

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 in academic years 2017-18 and 2018-19. Incoming 9th, 10th, and 11th grade female students in 10 Chicago Public Schools high schools 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. 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 : Interventional  (Clinical Trial)
Actual Enrollment : 3751 participants
Allocation: Randomized
Intervention 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.
Primary Purpose: Treatment
Official Title: The Promise of a School-Based, Trauma-Informed Cognitive Behavioral Therapy Intervention for Young Women in Chicago: A Randomized Evaluation
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : August 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. Change in anxiety assessment score [ Time Frame: Up to 36 months ]
    Score on self-reported anxiety screen, obtained from the BASC-3 SRP


Secondary Outcome Measures :
  1. Change in high school graduation [ Time Frame: Up to 5 years ]
    On-time graduation rate, obtained from Chicago Public Schools (CPS) administrative database

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. Change in other arrests (property, drug, and other) [ Time Frame: 1-year, 2-year, 3-year, 4-year, 5-year ]
    Number of non-violent crime arrests, including property crimes, drug crimes, and other crimes, obtained from CPD and ISP administrative databases


Other Outcome Measures:
  1. 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

  2. Change in sexual health and behaviors [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  3. Change in substance use [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  4. Change in school attitudes and engagement [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  5. Change in family cohesion [ Time Frame: Up to 36 months ]
    Measures adapted from the Family Environment Scale (relationships section), obtained from representative student survey

  6. Change in self-esteem (self-reliance, sense of inadequacy) [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  7. Change in emotional regulation [ Time Frame: Up to 36 months ]
    Score on the Difficulties in Emotion Regulation Scale - Short Form (DERS-SF), obtained from representative student survey

  8. 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

  9. Change in peer aggression [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  10. Change in somatization [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  11. Change in attention problems (hyperactivity) [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  12. Change in interpersonal relationships [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  13. Change in locus of control and anger management [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  14. Change in empowerment [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  15. Change in self-concept [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  16. Change in social supports [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey

  17. Change in perception of racial / cultural identity [ Time Frame: Up to 36 months ]
    Self-reported survey measures, obtained from representative student survey



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

  • Students with an overall attendance rate below 75% during AY2016-17
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03376633


Locations
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60602
Sponsors and Collaborators
University of Chicago
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

Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03376633     History of Changes
Other Study ID Numbers: IRB17-0585
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: February 27, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Chicago:
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

Additional relevant MeSH terms:
Disease
Depression
Anxiety Disorders
Wounds and Injuries
Stress Disorders, Traumatic
Mental Disorders
Psychotic Disorders
Stress Disorders, Post-Traumatic
Behavioral Symptoms
Trauma and Stressor Related Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders