Clinical trial NCT00751946: Girls In Recovery From Life Stress (GIRLS) Study
Official title: Girls In Recovery From Life Stress (GIRLS) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
PTSD
Keywords: Posttraumatic Stress Disorder
PTSD
psychotherapy
adolescents
clinical trial
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: U.S. Department of Justice
First posted: 2008-09-12
Enrollment: 70
Sex: FEMALE
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Interview (CAPS-CA) assessing posttraumatic stress disorder and questionnaires (PTCI, IPSI, TMQ, TSCC) and clinician ratings (SOTS) assessing posttraumatic stress symptom severity.
timeFrame: Post-treatment, 4-6 months post-treatment
Secondary outcomes:
measure: Questionnaires assessing problems with externalizing behaviors (Weinberger Adjustment Survey) and socioemotional strengths (Hope, NMR, Weinberger Adjustment Survey)
timeFrame: Post-treatment and 4-6 months post-treatment
Other outcomes:
Locations:
city: East Hartford
country: United States
facility: Polaris School
state: Connecticut
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Hartford
country: United States
facility: Gray Lodge Shelter for Women
state: Connecticut
city: Hartford
country: United States
facility: Weaver High School
state: Connecticut
city: Hartford
country: United States
facility: Bellizzi Middle School
state: Connecticut
city: Hartford
country: United States
facility: Quirk Middle School
state: Connecticut
city: West Hartford
country: United States
facility: UCONN Health Partners
state: Connecticut
Study officials:
affiliation: UConn Health
name: Julian Ford, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UConn Health
name: Kathie H Moffitt, Ph.D.
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.