Girls In Recovery From Life Stress (GIRLS) Study
Condition: Posttraumatic Stress Disorder; PTSD
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Stress, Psychological
Study type: Interventional
Phase: Phase 2

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.
    

Intervention name(s): Trauma Adaptive Recovery Group Education and Therapy; Enhanced Treatment As Usual
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Posttraumatic Stress Disorder; PTSD; psychotherapy; adolescents; clinical trial