Possibia

751946

Last Update Posted: 2010-09-27

Recruiting has ended

Females

accepted

13 Years-17 Years

70 Estimated Participants

No Expanded Access

Interventional Study

Does not accept healthy volunteers

Girls In Recovery From Life Stress (GIRLS) Study

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.

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

Relevant conditions:

Posttraumatic Stress Disorder

PTSD

If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the study if you think are close to fitting criteria.

locations

Data sourced from ClinicalTrials.gov