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Mothers Overcoming and Managing Stress (MOMS)

This study has been completed.
Sponsor:
Collaborator:
U.S. Department of Justice
Information provided by:
University of Connecticut Health Center
ClinicalTrials.gov Identifier:
NCT00751244
First received: September 10, 2008
Last updated: September 24, 2010
Last verified: September 2010
  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 reducing PTSD symptoms as a means of prevention of intergenerational victimization by or 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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Breaking the Cycle for Women With Behavioral Problems and Crime

Resource links provided by NLM:


Further study details as provided by University of Connecticut Health Center:

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
Active Comparator: 1
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.
Other Name: Julian Ford
Active Comparator: 2
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.
Other Name: McDonagh-Coyle
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.

Detailed Description:

Hypotheses, Objectives and Aims:

The study is a randomized clinical trial comparing two stress management counseling interventions with a wait-list comparison condition to determine their efficacy in addressing behavioral, cognitive, affective, and interpersonal effects of PTSD that often occurs for persons living in adverse socioeconomic circumstances and in violent families and communities. One goal of the study is to reduce the severity of or produce remission from PTSD, in order to reduce impulsivity, aggression, dissociation, and isolation by high-risk or previously incarcerated women. The long-term goal, which will be assessed in subsequent studies over time is to reduce the likelihood of their or their children becoming involved in, or victimized by other persons' involvement in, illegal activities. Children will not be involved in the present study, only women who are the mothers of young children.

Aim #1: To test the efficacy of TARGET and PCT. TARGET (Frisman, L., Ford, J. D., Lin, H., Mallon, S., & Chang, R., 2008) and PCT (McDonagh A, Friedman M, McHugo G, Ford J, Sengupta A, Mueser K, Demment CC, Fournier D, Schnurr PP, Descamps M., 2005) have demonstrated efficacy in randomized trial studies, but have not been tested specifically with mothers of young children. The study will assess outcomes that are of potential importance not only for the well being of the participating women but for their ability to develop secure attachments with their child which are protective against exposure to violence, crime, and victimization and associated with positive psychosocial development by children. Outcome measures reflect self-regulatory capacities compromised by trauma that are essential for effective caregiving by adults.

Aim #2: To compare the efficacy of TARGET and PCT on theory-based differential outcomes. TARGET and PCT use similar but different therapeutic strategies. Each teaches skills for managing negative emotions and critical symptoms (e.g., inhibiting impulsivity). TARGET teaches a skill sequence for affect regulation and social/interoceptive information processing, while PCT teaches a skill sequence for recognizing and solving problems in relationships. We expect that TARGET and PCT will reduce stress-related avoidance and depression and enhance active coping with current stressors. TARGET should be superior to PCT in enhancing the ability to cope with trauma memories, stress reactivity, and anxiety, and therefore the ability to remain free from illegal activities or future or further involvement with criminal justice systems. PCT should be superior to TARGET in enhancing the participant's overall social adjustment.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030
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
Sponsors and Collaborators
University of Connecticut Health Center
U.S. Department of Justice
Investigators
Principal Investigator: Julian Ford, Ph.D. University of Connecticut Health Center
Study Director: Joan Levine, M.P.H. University of Connecticut Health Center
  More Information

Additional Information:
Publications:
Finkelhor, D. (1987). The trauma of child sexual abuse. Journal of Interpersonal Violence, 2, 348-366.
Ford, J. D. (2002). Traumatic victimization in childhood and persistent problems with oppositional-defiance. Journal of Trauma, Maltreatment, and Aggression, 11, 25-58.
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: Julian Ford, Ph.D., University of Connecticut Health Center
ClinicalTrials.gov Identifier: NCT00751244     History of Changes
Other Study ID Numbers: 05-051H-1, 2004-DD-BX-1025
Study First Received: September 10, 2008
Last Updated: September 24, 2010
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by University of Connecticut Health Center:
women
posttraumatic stress disorder
PTSD
psychotherapy
clinical trial
emotion regulation

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 25, 2014