Clinical trial NCT00751244: Mothers Overcoming and Managing Stress
Official title: Breaking the Cycle for Women With Behavioral Problems and Crime
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Posttraumatic Stress Disorder
PTSD
Keywords: women
posttraumatic stress disorder
PTSD
psychotherapy
clinical trial
emotion regulation
Lead sponsor: UConn Health
Sponsor class: OTHER
Collaborators: name: U.S. Department of Justice
First posted: 2008-09-11
Enrollment: 147
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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 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

Primary outcomes:
measure: 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).
timeFrame: post-therapy, 3-month and 6-month follow-ups
Secondary outcomes:
measure: 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.
timeFrame: Post-treatment, 3-month and 6-month follow-ups
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center
state: Connecticut
city: Hartford
country: United States
facility: Burgdorf Clinic/Bank of America Health Center on the Mount Sinai Campus of Saint Francis Hospital and Medical Center
state: Connecticut
Study officials:
affiliation: UConn Health
name: Julian Ford, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UConn Health
name: Joan Levine, M.P.H.
role: STUDY_DIRECTOR
References:
citation: Finkelhor, D. (1987). The trauma of child sexual abuse. Journal of Interpersonal Violence, 2, 348-366.
citation: 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.
citation: 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.
citation: Ford, J. D. (2002). Traumatic victimization in childhood and persistent problems with oppositional-defiance. Journal of Trauma, Maltreatment, and Aggression, 11, 25-58.
citation: 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.
citation: 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