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

This study is currently recruiting participants.
Verified July 2017 by Nadine Kaslow, PhD, Emory University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00601939
First Posted: January 28, 2008
Last Update Posted: August 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Nadine Kaslow, PhD, Emory University
  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
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Group Interventions for Abused, Suicidal Black Women

Resource links provided by NLM:


Further study details as provided by Nadine Kaslow, PhD, 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 ]

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 ]

Estimated Enrollment: 190
Study Start Date: March 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Nadine J. Kaslow, PhD Emory University
  More Information

Responsible Party: Nadine Kaslow, PhD, Chief Psychologist, Emory University
ClinicalTrials.gov Identifier: NCT00601939     History of Changes
Other Study ID Numbers: IRB00045774
R01MH078002 ( U.S. NIH Grant/Contract )
DSIR 83-ATP
First Submitted: January 15, 2008
First Posted: January 28, 2008
Last Update Posted: August 1, 2017
Last Verified: July 2017

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

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