Girls In Recovery From Life Stress (GIRLS) Study (GIRLS)
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|ClinicalTrials.gov Identifier: NCT00751946|
Recruitment Status : Completed
First Posted : September 12, 2008
Last Update Posted : September 27, 2010
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder PTSD||Behavioral: Trauma Adaptive Recovery Group Education and Therapy Behavioral: Enhanced Treatment As Usual||Phase 2|
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.
An ethnically diverse sample 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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Girls In Recovery From Life Stress (GIRLS) Study|
|Study Start Date :||March 2006|
|Actual Primary Completion Date :||August 2008|
|Actual Study Completion Date :||August 2008|
Active Comparator: 1
12 weekly sessions of one-to-one TARGET (psychotherapy)
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.
Active Comparator: 2
12 weekly sessions of one-to-one ETAU (psychotherapy)
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.
- Interview (CAPS-CA) assessing posttraumatic stress disorder and questionnaires (PTCI, IPSI, TMQ, TSCC) and clinician ratings (SOTS) assessing posttraumatic stress symptom severity. [ Time Frame: Post-treatment, 4-6 months post-treatment ]
- Questionnaires assessing problems with externalizing behaviors (Weinberger Adjustment Survey) and socioemotional strengths (Hope, NMR, Weinberger Adjustment Survey) [ Time Frame: Post-treatment and 4-6 months post-treatment ]
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): NCT00751946
|United States, Connecticut|
|East Hartford, Connecticut, United States, 06108|
|University of Connecticut Health Center|
|Farmington, Connecticut, United States, 06030|
|Gray Lodge Shelter for Women|
|Hartford, Connecticut, United States, 06105|
|Weaver High School|
|Hartford, Connecticut, United States, 06112|
|Bellizzi Middle School|
|Hartford, Connecticut, United States, 06114|
|Quirk Middle School|
|Hartford, Connecticut, United States, 06120|
|UCONN Health Partners|
|West Hartford, Connecticut, United States, 06119|
|Principal Investigator:||Julian Ford, Ph.D.||UConn Health|
|Study Director:||Kathie H Moffitt, Ph.D.||UConn Health|