Effectiveness of Empowerment Group Sessions for Treating Suicidal African American Women in Abusive Relationships

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Emory University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Nadine Kaslow, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00601939
First received: January 15, 2008
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

This study will evaluate the effectiveness of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.


Condition Intervention Phase
Battered Women
Suicide, Attempted
Behavioral: Psychoeducational intervention (PEI)
Behavioral: Enhanced treatment as usual (ETAU)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Group Interventions for Abused, Suicidal Black Women

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Beck Scale for Suicidal Ideation; Suicide Attempt Index; Index of Spouse Abuse [ Time Frame: Measured at Week 10 and Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Beck Depression Inventory - II; Beck Hopelessness Scale; Self Efficacy Scale for Battered Women [ Time Frame: Measured at Week 10 and Months 6 and 12 post-treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 190
Study Start Date: March 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Culturally competent group empowerment psychoeducational treatment
Behavioral: Psychoeducational intervention (PEI)
PEI consists of 10 culturally competent group empowerment psychoeducational sessions. The sessions are directed by a treatment manual and are co-led by two therapists. The sessions are guided by the theory of triadic influence (TTI) model, which incorporates cultural-environmental influences, social-situational influences, and intrapersonal influences into treatment.
Other Name: Theory of triadic influence
Active Comparator: 2
Enhanced treatment as usual that includes an adherence protocol
Behavioral: Enhanced treatment as usual (ETAU)
ETAU contains an adherence protocol plus access to weekly support group and a resource room.

Detailed Description:

Most suicide attempts are a sign of great distress, often originating from depression; physical and sexual abuse; substance abuse; or family history of suicide, violence, or mental disorder. Risk factors for suicidal behavior are diverse, differing with gender, age, and ethnicity. Since the mid-1980s, the number of reported suicides and suicidal thoughts among young black individuals has increased alarmingly. The higher rates may be caused by high stress living situations attributed to poverty, abuse, discrimination, racism, and difficult family life. Therefore, cultural environments, social situations, and intrapersonal influences are important considerations in developing an effective therapy to prevent suicide. This study will evaluate the effect of culturally competent psychoeducational empowerment sessions in treating suicidal African-American women who are in abusive relationships.

The participants in this single-blind study will be randomly placed in one of two treatment groups. One group will receive psychoeducational intervention (PEI) and the other will receive enhanced treatment as usual (ETAU). After screening, eligible participants will complete a 2-hour survey about life events, concerns, and feelings with a research team member. One week later, participants will complete a second 1-hour survey. Participants will then be randomly placed in the treatment groups. Participants in both groups will receive treatment at Grady Health System, but those in the PEI group will also attend 10 weekly, 90-minute group sessions. The PEI empowerment group sessions will incorporate cultural, social, and intrapersonal elements. The ETAU group will be given mental health treatment as usual plus an adherence enhancement protocol. Follow-up surveys will occur at Week 10 (after treatment completion) and at Months 6 and 12 post-treatment.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Identifies as an African-American female
  • Abusive relationship within the 12 months prior to study entry
  • Suicide attempt within the 12 months prior to study entry
  • Seeks services at Grady Health System

Exclusion Criteria:

  • Score of less than 22 on Mini Mental Status Exam (MMSE)
  • Score of less than 18 on Rapid Estimate of Adult Literacy in Medicine (REALM)
  • Acutely psychotic
  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: NCT00601939

Contacts
Contact: Nadine J. Kaslow, PhD 404-616-4757 nkaslow@emory.edu
Contact: Barbara D'Orio, MD 404-616-4760 bdorio@emory.edu

Locations
United States, Georgia
Grady Hospital Recruiting
Atlanta, Georgia, United States, 30303
Principal Investigator: Nadine J. Kaslow, PhD         
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Nadine J. Kaslow, PhD Emory University
  More Information

No publications provided

Responsible Party: Nadine Kaslow, PhD, Chief Psychologist, Emory University
ClinicalTrials.gov Identifier: NCT00601939     History of Changes
Other Study ID Numbers: IRB00045774, R01MH078002, DSIR 83-ATP
Study First Received: January 15, 2008
Last Updated: April 30, 2014
Health Authority: United States: Federal Government

Keywords provided by Emory University:
Abused
Female
African American
Group Empowerment Psychoeducational Intervention
Enhanced Treatment as Usual

Additional relevant MeSH terms:
Suicide, Attempted
Behavioral Symptoms
Self-Injurious Behavior
Suicide

ClinicalTrials.gov processed this record on October 23, 2014