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

NCT ID: NCT00601939

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 397 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2028-12-31

Brief Summary

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

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.

Conditions

Battered Women; Suicide, Attempted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Psychoeducational intervention (PEI)

Culturally competent group empowerment psychoeducational treatment (group intervention that is culturally informed and educational in nature)

Group Type: EXPERIMENTAL

Psychoeducational intervention (PEI)

Intervention Type: BEHAVIORAL

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.

Enhanced Treatment as Usual

Enhanced treatment as usual that includes an adherence protocol (regular care at the hospital plus an adherence protocol)

Group Type: ACTIVE_COMPARATOR

Enhanced treatment as usual (ETAU)

Intervention Type: BEHAVIORAL

ETAU contains an adherence protocol plus access to weekly support group and a resource room.

Interventions

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.

Intervention Type: BEHAVIORAL

Enhanced treatment as usual (ETAU)

ETAU contains an adherence protocol plus access to weekly support group and a resource room.

Intervention Type: BEHAVIORAL

Other Intervention Names

Theory of triadic influence

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Nadine Kaslow

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nadine J. Kaslow, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Grady Hospital

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Nadine J. Kaslow, PhD

Role: CONTACT

nkaslow@emory.edu

404-616-4757

Barbara D'Orio, MD

Role: CONTACT

bdorio@emory.edu

404-616-4760

Facility Contacts

Nadine J. Kaslow, PhD

Role: primary

References

Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

Reference Type: DERIVED

PMID: 33884617 (View on PubMed)

Other Identifiers

R01MH078002

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00045774

Identifier Type: -

Identifier Source: org_study_id