Mothers Overcoming and Managing Stress - Full Text View

Sponsors and Collaborators:	University of Connecticut Health Center US National Institute of Justice US Department of Justice Office of Juvenile Justice and Delinquency Prevention Department of Justice
Information provided by:	University of Connecticut
ClinicalTrials.gov Identifier:	NCT00751244

Purpose

The study is a randomized trial of two manualized 12-session one-to-one educational and therapeutic interventions for post-traumatic stress disorder (PTSD), to test and compare their efficacy for the prevention of intergenerational involvement in criminal activities with at-risk mothers. The two therapies are (1) Trauma Affect Regulation: Guide for Education and Therapy (TARGET) and (2) Present Centered Therapy (PCT). The study also included a wait-list comparison condition in which participants were offered one of the two therapies following completion of baseline and posttest assessments.

Condition	Intervention	Phase
Posttraumatic Stress Disorder PTSD	Behavioral: Trauma Affect Regulation: Guide for Education and Therapy Behavioral: Present Centered Therapy (PCT) - psychotherapy Other: No-treatment "waitlist" group	Phase II

MedlinePlus related topics: Injuries Post-Traumatic Stress Disorder Wounds

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title:	Breaking the Cycle for Women With Behavioral Problems and Crime

Further study details as provided by University of Connecticut:

Primary Outcome Measures:

Reduced PTSD symptoms/impairment as evidenced by improvements on the Clinician Administered PTSD Scale (CAPS), Post-Traumatic Cognitions Inventory (PTCI), Traumatic Memories Questionnaire (TMQ), and the Interpretation of PTSD Symptoms Inventory (IPSI). [ Time Frame: post-therapy, 3-month and 6-month follow-ups ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Improved affect/interpersonal self-regulation as evidenced by improvement on the Negative Mood Regulation Scale, Inventory of Interpersonal Problems, Multiscale Dissociation Inventory, Anxiety Inventory, and Beck Depression Inventory. [ Time Frame: Post-treatment, 3-month and 6-month follow-ups ] [ Designated as safety issue: Yes ]

Enrollment:	147
Study Start Date:	January 2005
Study Completion Date:	November 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator 12 weekly sessions of one-to-one TARGET (psychotherapy)	Behavioral: Trauma Affect Regulation: Guide for Education and Therapy Trauma Affect Regulation: Guide for Education and Therapy (TARGET; Ford & Russo, 2006) is a manualized gender-specific treatment for PTSD. TARGET teaches a practical 7-step sequence of skills for processing and managing trauma-related reactions to current stressful experiences, summarized by a mnemonic ("FREEDOM"), e.g., Focusing ("F"), Recognizing current triggers. TARGET also involves creative arts activities, i.e., personalized "lifelines" via collage, drawing, poetry, and writing that may include traumatic experiences but emphasize "life story" narrative reconstruction with no exposure therapy.
2: Active Comparator 12 weekly sessions of one-to-one PCT (psychotherapy)	Behavioral: Present Centered Therapy (PCT) - psychotherapy Present Centered Therapy (PCT) is a 12-session supportive therapy adapted a 14-session version co-developed by the first author (McDonagh-Coyle et al., 2005). Psychoeducation is provided about the link between traumatic events, PTSD symptoms, and problems in relationships, and social problem solving skills are taught to address the "traumagenic dynamics" of betrayal, stigma, powerlessness, and sexualization (Finkelhor, 1987). PCT focuses on addressing current problems rather than trauma memory-based exposure therapy, and uses a distinctive mnemonic to organize the skill set. PCT has clients keep a journal of relational stressors and responses as between-session homework.
3 90-day wait-list group	Other: No-treatment "waitlist" group After a 90 day wait-list period, participants were invited to choose one of the treatment approaches (PCT or TARGET) and engage in 12 sessions of therapy.

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Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Female
Age 18-50 years old (or emancipated minor)
Primary care-giver of a child aged 0-5 years old
A history of incarceration, or substance abuse, or exposure to violence
Mentally able to participate and provide valid consent
Able to complete the consent process, interviews, self-report measure and treatment/intervention primarily in English
Willing to consent to be audio and/or videotaped for research purposes in intervention sessions
Current post-traumatic stress disorder as assessed by study personnel

Exclusion Criteria:

Imminently suicidal
Past 30 days inpatient psychiatric treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751244

Locations

United States, Connecticut
Burgdorf Clinic/Bank of America Health Center on the Mount Sinai Campus of Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06112-1548
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030

Sponsors and Collaborators

University of Connecticut Health Center

US National Institute of Justice

US Department of Justice Office of Juvenile Justice and Delinquency Prevention

Department of Justice

Investigators

Principal Investigator:	Julian Ford, Ph.D.	University of Connecticut Health Center
Study Director:	Kathie H Moffitt, Ph.D.	University of Connecticut Health Center

More Information

Click here for more information about the TARGET treatment model. This link exits the ClinicalTrials.gov site

Publications:

Finkelhor, D. (1987). The trauma of child sexual abuse. Journal of Interpersonal Violence, 2, 348-366.

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.

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.

Wolpaw, J., Ford, J. D., Newman, E., Davis, J. L., & Briere, J. (2005). Trauma Symptom Checklist for Children: In T. Grisso, G. Vincent & D. Seagrave (Eds.), Mental health screening and assessment in juvenile justice (pp. 152-165). New York: Guilford.

Responsible Party:	University of Connecticut Health Center ( Julian Ford, Ph.D. )
Study ID Numbers:	05-051H-1, 2004-DD-BX-1025
Study First Received:	September 10, 2008
Last Updated:	September 10, 2008
ClinicalTrials.gov Identifier:	NCT00751244
Health Authority:	United States: Institutional Review Board; United States: Federal Government

Keywords provided by University of Connecticut:

women
posttraumatic stress disorder
PTSD

psychotherapy
clinical trial
emotion regulation

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Stress Disorders, Post-Traumatic
Stress
Stress Disorders, Traumatic

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on January 16, 2009