Recruiting

Empowerment Group Sessions

Sponsor:

Emory University

Code:

NCT00601939

Conditions

Battered Women

Suicide, Attempted

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Not accepted

Interventions

Psychoeducational intervention (PEI)

Enhanced treatment as usual (ETAU)

Study Details

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.

Conditions

Battered Women

Suicide, Attempted

Study ID

NCT00601939

Start date

Mar, 2008

Status verified date

Nov, 2024

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 64

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

397 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Psychoeducational intervention (PEI)

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

active comparator: Enhanced Treatment as Usual

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

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.

Enhanced treatment as usual (ETAU)

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

Primary outcome measure

  • Change in Beck Scale for Suicide Ideation Score [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]
  • Change in Suicide Attempt Index [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]
  • Change in Index of Spouse Abuse Score [ Time Frame: Baseline, Week 10, Post-treatment Months 6 and 12 ]

Central Contacts and Locations

Central contacts

Nadine J. Kaslow, PhD

404-616-4757nkaslow@emory.edu

Barbara D'Orio, MD

404-616-4760bdorio@emory.edu

Locations

Grady Hospital

Recruiting

Atlanta, Georgia, United States, 30303

More Information

Sponsor

Emory University

Last update posted

Nov 12, 2024

Last verified

Nov, 2024

Keywords

  • Abused
  • Female
  • African American
  • Group Empowerment Psychoeducational Intervention
  • Enhanced Treatment as Usual

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2024-11-12.