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

NCT03376633 | Completed

• 1 other identifier: IRB17-0585
• Study Type: interventional
• Target: 5,106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

1. 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. 2.To evaluate the cost-effectiveness of the WOW program.

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

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  Up to 36 months

• Change in anxiety assessment score

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

  Up to 36 months

Secondary Outcomes (8)

• Change in high school graduation

  Up to 5 years

• Change in absences

  1-year, 2-year, 3-year, 4-year, 5-year

• Change in index of CPS schooling outcomes

  1-year, 2-year, 3-year, 4-year, 5-year

• Change in student misconduct

  1-year, 2-year, 3-year, 4-year, 5-year

• Change in course failures

  1-year, 2-year, 3-year, 4-year, 5-year

Other Outcomes (17)

• Change in pregnancy/childbirth rate

  1-year, 2-year, 3-year, 4-year, 5-year

• Change in sexual health and behaviors

  Up to 36 months

• Change in substance use

  Up to 36 months

Study Arms (2)

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.

Behavioral: Working on Womanhood (WOW)

Interventions

Working on Womanhood (WOW) BEHAVIORAL

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

WOW Group and Individual Counseling

Eligibility Criteria

• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Chicago: lead
• Northwestern University: collaborator
• Youth Guidance: collaborator
• Chicago Public Schools: collaborator
• U.S. Department of Justice: collaborator
• Paul M. Angell Family Foundation: collaborator
• Polk Bros. Foundation: collaborator
• The Reva & David Logan Foundation: collaborator
• DePaul University: collaborator
• Laura and John Arnold Foundation: collaborator
• MacArthur Foundation: collaborator

Study Sites (1)

University of Chicago

Chicago, Illinois, 60602, United States

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 4, 2017
• First Posted: December 18, 2017
• Study Start: October 1, 2017
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: August 24, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)