NCT00751946

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2006

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 11, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 12, 2008

Completed
Last Updated

September 27, 2010

Status Verified

September 1, 2010

Enrollment Period

2.4 years

First QC Date

September 11, 2008

Last Update Submit

September 24, 2010

Conditions

Posttraumatic Stress DisorderPTSD

Keywords

Posttraumatic Stress DisorderPTSDpsychotherapyadolescentsclinical trial

Outcome Measures

Primary Outcomes (1)

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

    Post-treatment, 4-6 months post-treatment

Secondary Outcomes (1)

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

    Post-treatment and 4-6 months post-treatment

Study Arms (2)

1

ACTIVE COMPARATOR

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

Behavioral: Trauma Adaptive Recovery Group Education and Therapy

2

ACTIVE COMPARATOR

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

Behavioral: Enhanced Treatment As Usual

Interventions

Trauma Adaptive Recovery Group Education and TherapyBEHAVIORAL

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.

1
Enhanced Treatment As UsualBEHAVIORAL

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.

2

Eligibility Criteria

Age13 Years - 17 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Polaris School

East Hartford, Connecticut, 06108, United States

Location

University of Connecticut Health Center

Farmington, Connecticut, 06030, United States

Location

Gray Lodge Shelter for Women

Hartford, Connecticut, 06105, United States

Location

Weaver High School

Hartford, Connecticut, 06112, United States

Location

Bellizzi Middle School

Hartford, Connecticut, 06114, United States

Location

Quirk Middle School

Hartford, Connecticut, 06120, United States

Location

UCONN Health Partners

West Hartford, Connecticut, 06119, United States

Location

Related Publications (4)

  • 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.

    PMID: 16281241BACKGROUND

  • 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.

    PMID: 17340945BACKGROUND

  • 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.

    BACKGROUND

  • 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.

    PMID: 15982149BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Julian Ford, Ph.D.

    UConn Health

    PRINCIPAL INVESTIGATOR

  • Kathie H Moffitt, Ph.D.

    UConn Health

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 11, 2008

First Posted

September 12, 2008

Study Start

March 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

September 27, 2010

Record last verified: 2010-09

Locations

US(7)