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Sponsors and Collaborators: |
University of Connecticut Health Center Office of Juvenile Justice and Delinquency Prevention U.S. Department of Justice |
Information provided by: | University of Connecticut |
ClinicalTrials.gov Identifier: | NCT00751946 |
This study will compare treatment outcomes of 90 adolescent girls who are (a) at high risk for delinquency and/or are juvenile justice involved, and (b) who are experiencing symptoms of PTSD: 45 of the girls will receive Trauma Affect Regulation: Guide for Education and Therapy (TARGET, Frisman, Ford, Lin, Mallon, & Chang, in press), and their outcomes will be compared to 45 girls who receive Enhanced Treatment as Usual (ETAU). As part of their involvement, participants will make phone calls to provide data via an interactive voice response system (IVR), meet 3 times for a research interview, and be invited to participate in a cognitive assessment substudy at the Olin Neuropsychiatric Research Center at Hartford Hospital.
Condition | Intervention | Phase |
Posttraumatic Stress Disorder PTSD |
Behavioral: Trauma Adaptive Recovery Group Education and Therapy Behavioral: Enhanced Treatment As Usual |
Phase II |
MedlinePlus related topics: | Injuries Post-Traumatic Stress Disorder Stress Wounds |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Girls In Recovery From Life Stress (GIRLS) Study |
Enrollment: | 70 |
Study Start Date: | March 2006 |
Study Completion Date: | August 2008 |
Primary Completion Date: | August 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Active Comparator
12 weekly sessions of one-to-one TARGET (psychotherapy)
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Behavioral: Trauma Adaptive Recovery Group Education and Therapy
Trauma Affect Regulation: Guidelines for Education and Therapy (TARGET; Ford & Russo, 2006) is a manualized gender-specific treatment for PTSD. The 12-session individual therapy version in the present study is being adapted for adolescent girls based on a parallel version for young mothers and a group version that has been field tested with more than 20 adolescent girls. TARGET teaches a practical 7-step sequence of skills for processing and managing trauma-related reactions to current stressful experiences. The skills are designed in a sequence mirroring the three phases of complex traumatic stress disorder treatment (Ford, Courtois, Van der Hart, Nijenhuis & Steele, 2005), summarized by an acronym "FREEDOM". TARGET also uses creative arts activities: personalized "lifelines" via collage, drawing, poetry, and writing. |
2: Active Comparator
12 weekly sessions of one-to-one ETAU (psychotherapy)
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Behavioral: Enhanced Treatment As Usual
Enhanced Treatment as Usual (ETAU) is a 12-session supportive therapy adapted from the Present Centered Therapy co-developed by the first author (McDonagh-Coyle, Friedman, McHugo, Ford, Mueser, & Sengupta, 2005). In ETAU therapists invite the participant to talk about goals or problems that are important to her. The therapist's focus is on providing the core conditions of client centered psychotherapy (nonjudgmental acceptance, empathy, interpersonal warmth) and engaging the participant in a strengths-based solution-focused reflection on how she is successful (or has been in the past) in managing stressors, handling problems, achieving personal goals, and developing healthy relationships with peers, family, and other community members.
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Hypotheses, Objectives and Aims:
The purpose of the GIRLS study is to provide counseling to adolescent girls who are (a) at high risk for delinquency and/or are juvenile justice involved and (b) are experiencing symptoms of PTSD, in order to help them regulate their emotions, planning, decision-making, and actions/ interactions in ways that will reduce PTSD and enhance their safety, responsible civic involvement, learning, peer, family, and adult relationships, and physical and psychological well-being. The study will be the first randomized clinical trial of a therapeutic intervention for complex post-traumatic stress disorder (PTSD)with girls: 1) Trauma Affect Regulation: Guide for Education and Therapy (TARGET; Frisman, Ford, Lin, Mallon, & Chang, in press), compared to Enhanced Treatment as Usual (ETAU). Both interventions will provide 12 one-to-one manualized, educational and therapeutic sessions that teach coping skills and stress reduction techniques.
The aims of the study are:
Aim 1) To test if participation in TARGET results in clinically and statistically significant improvements in PTSD symptoms, psychosocial functioning, and emotion/impulse regulation.
Aim 2) To compare the differential affects of TARGET and ETAU on affect regulation, social support, stress-related information processing and cognitive coping, and the reduction of impulsive or aggressive thinking/behavior.
Aim 3) To identify changes in daily self-regulation after TARGET and ETAU.
Aim 4) To identify alterations in brain activity that change after TARGET and ETAU.
An ethnically diverse sample (N=90) of girls at high risk for delinquency and/or with current or past juvenile justice-involvement between 13 and 17 years of age will be recruited in clinic, community, detention, schools, and residential programs. After screening for eligibility and obtaining valid signed consent forms, participants will be randomly assigned to one of the two experimental conditions. Within each condition, trained clinicians will administer 12 sessions of individualized counseling using a manual for the specified intervention. Psychometric self-report and daily monitoring measures will be obtained at baseline, post-treatment, and 6-month follow-up assessments and multivariate statistical techniques will be used for analysis of treatment effects.
Scientific Background and Significance:
Prior research highlights the need to address trauma among justice-involved and delinquent adolescent girls. Delinquency and other high-risk behaviors (e.g., substance use and suicidal ideation) among adolescent girls are often associated with exposure to domestic violence, as well as physical and sexual abuse. Most have experienced past traumas. Impulsive behaviors and poor coping skills often jeopardize and place them at risk for further victimization, physical and psychological harm, and deeper involvement in criminal activities. Consequently, mental health and juvenile justice professionals recognize the need to engage at-risk girls in age-appropriate and gender-sensitive treatment services that treat trauma-related symptoms. However, research that demonstrates the effectiveness of trauma-sensitive interventions for adolescents is still needed. The current study will build the evidence base for the adolescent version of Trauma Affect Regulation: Guide for Education and Therapy, (TARGET) a promising trauma treatment for adolescents.
Ages Eligible for Study: | 13 Years to 17 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Connecticut | |||||
University of Connecticut Health Center | |||||
Farmington, Connecticut, United States, 06030 | |||||
Weaver High School | |||||
Hartford, Connecticut, United States, 06112 | |||||
UCONN Health Partners | |||||
West Hartford, Connecticut, United States, 06119 | |||||
Quirk Middle School | |||||
Hartford, Connecticut, United States, 06120 | |||||
Gray Lodge Shelter for Women | |||||
Hartford, Connecticut, United States, 06105 | |||||
Polaris School | |||||
East Hartford, Connecticut, United States, 06108 | |||||
Bellizzi Middle School | |||||
Hartford, Connecticut, United States, 06114 |
University of Connecticut Health Center |
Office of Juvenile Justice and Delinquency Prevention |
U.S. Department of Justice |
Principal Investigator: | Julian Ford, Ph.D. | University of Connecticut Health Center |
Study Director: | Kathie H Moffitt, Ph.D. | University of Connecticut Health Center |
Click here for more information about the TARGET treatment model. 
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Responsible Party: | University of Connecticut Health Center ( Julian Ford, Ph.D. ) |
Study ID Numbers: | 06-035H-2, 2005-MU-MU-K013 |
First Received: | September 11, 2008 |
Last Updated: | September 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00751946 |
Health Authority: | United States: Institutional Review Board; United States: Federal Government |
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