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Girls In Recovery From Life Stress (GIRLS) Study (GIRLS)

Primary Purpose

Posttraumatic Stress Disorder, PTSD

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Trauma Adaptive Recovery Group Education and Therapy
Enhanced Treatment As Usual
Sponsored by
UConn Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Posttraumatic Stress Disorder, PTSD, psychotherapy, adolescents, clinical trial

Eligibility Criteria

13 Years - 17 Years (Child)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Female
  • Age 13-17 years old
  • Past and/or current juvenile justice involvement AND/OR past and/or current delinquent behavior
  • Able to obtain assent from youth
  • Able to obtain consent from legal guardian
  • Willing to assent/consent to be audiotaped for research purposes in assessment and intervention sessions
  • Currently experiencing negative reactions to past traumas (PTSD symptoms)

Exclusion Criteria:

  • Imminently suicidal
  • Past 30 days inpatient psychiatric treatment
  • IF meetings take place at a school or group facility and the girl/participant is NOT willing to schedule appointments through the school or group facility staff

Sites / Locations

  • Polaris School
  • University of Connecticut Health Center
  • Gray Lodge Shelter for Women
  • Weaver High School
  • Bellizzi Middle School
  • Quirk Middle School
  • UCONN Health Partners

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

1

2

Arm Description

12 weekly sessions of one-to-one TARGET (psychotherapy)

12 weekly sessions of one-to-one ETAU (psychotherapy)

Outcomes

Primary Outcome Measures

Interview (CAPS-CA) assessing posttraumatic stress disorder and questionnaires (PTCI, IPSI, TMQ, TSCC) and clinician ratings (SOTS) assessing posttraumatic stress symptom severity.

Secondary Outcome Measures

Questionnaires assessing problems with externalizing behaviors (Weinberger Adjustment Survey) and socioemotional strengths (Hope, NMR, Weinberger Adjustment Survey)

Full Information

First Posted
September 11, 2008
Last Updated
September 24, 2010
Sponsor
UConn Health
Collaborators
U.S. Department of Justice
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1. Study Identification

Unique Protocol Identification Number
NCT00751946
Brief Title
Girls In Recovery From Life Stress (GIRLS) Study
Acronym
GIRLS
Official Title
Girls In Recovery From Life Stress (GIRLS) Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UConn Health
Collaborators
U.S. Department of Justice

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder, PTSD
Keywords
Posttraumatic Stress Disorder, PTSD, psychotherapy, adolescents, clinical trial

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
12 weekly sessions of one-to-one TARGET (psychotherapy)
Arm Title
2
Arm Type
Active Comparator
Arm Description
12 weekly sessions of one-to-one ETAU (psychotherapy)
Intervention Type
Behavioral
Intervention Name(s)
Trauma Adaptive Recovery Group Education and Therapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Enhanced Treatment As Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Female Age 13-17 years old Past and/or current juvenile justice involvement AND/OR past and/or current delinquent behavior Able to obtain assent from youth Able to obtain consent from legal guardian Willing to assent/consent to be audiotaped for research purposes in assessment and intervention sessions Currently experiencing negative reactions to past traumas (PTSD symptoms) Exclusion Criteria: Imminently suicidal Past 30 days inpatient psychiatric treatment IF meetings take place at a school or group facility and the girl/participant is NOT willing to schedule appointments through the school or group facility staff
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julian Ford, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathie H Moffitt, Ph.D.
Organizational Affiliation
UConn Health
Official's Role
Study Director
Facility Information:
Facility Name
Polaris School
City
East Hartford
State/Province
Connecticut
ZIP/Postal Code
06108
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Gray Lodge Shelter for Women
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Weaver High School
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06112
Country
United States
Facility Name
Bellizzi Middle School
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06114
Country
United States
Facility Name
Quirk Middle School
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06120
Country
United States
Facility Name
UCONN Health Partners
City
West Hartford
State/Province
Connecticut
ZIP/Postal Code
06119
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
16281241
Citation
Ford JD, Courtois CA, Steele K, Hart Ov, Nijenhuis ER. Treatment of complex posttraumatic self-dysregulation. J Trauma Stress. 2005 Oct;18(5):437-47. doi: 10.1002/jts.20051.
Results Reference
background
PubMed Identifier
17340945
Citation
Ford JD, Russo E. Trauma-focused, present-centered, emotional self-regulation approach to integrated treatment for posttraumatic stress and addiction: trauma adaptive recovery group education and therapy (TARGET). Am J Psychother. 2006;60(4):335-55. doi: 10.1176/appi.psychotherapy.2006.60.4.335.
Results Reference
background
Citation
Frisman, L., Ford, J. D., Lin, H., Mallon, S., & Chang, R. (in press). Outcomes of trauma treatment using the TARGET model. Journal of Groups in Addiction and Recovery.
Results Reference
background
PubMed Identifier
15982149
Citation
McDonagh A, Friedman M, McHugo G, Ford J, Sengupta A, Mueser K, Demment CC, Fournier D, Schnurr PP, Descamps M. Randomized trial of cognitive-behavioral therapy for chronic posttraumatic stress disorder in adult female survivors of childhood sexual abuse. J Consult Clin Psychol. 2005 Jun;73(3):515-24. doi: 10.1037/0022-006X.73.3.515.
Results Reference
background
Links:
URL
http://www.advancedtrauma.com
Description
Click here for more information about the TARGET treatment model.

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Girls In Recovery From Life Stress (GIRLS) Study

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