NCT00601939

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
397

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Mar 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Mar 2008Dec 2028

First Submitted

Initial submission to the registry

January 15, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 28, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2008

Completed
20.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2028

Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

20.8 years

First QC Date

January 15, 2008

Last Update Submit

November 8, 2024

Conditions

Battered WomenSuicide, Attempted

Keywords

AbusedFemaleAfrican AmericanGroup Empowerment Psychoeducational InterventionEnhanced Treatment as Usual

Outcome Measures

Primary Outcomes (3)

  • Change in Beck Scale for Suicide Ideation Score

    The Beck Scale for Suicide (BSS) Ideation consists of 19 items with responses rated on a scale from 0 to 2. Total scores range from 0 to 38 with higher scores indicating greater feelings of suicide ideation.

    Baseline, Week 10, Post-treatment Months 6 and 12

  • Change in Suicide Attempt Index

    Created for this study, this qualitative screening measure asks if participants have engaged in the suicidal behaviors of intentionally overdosing, cutting self, tried to shoot self or jump from a high place, tried to take life, and attempting suicide.

    Baseline, Week 10, Post-treatment Months 6 and 12

  • Change in Index of Spouse Abuse Score

    The Index of Spouse Abuse (ISA) is a 30-item instrument where participants report how frequently abuse situations occur where 1 = never and 5 = very frequently. Total scores range from 30 to 150 and higher scores indicate a higher degree of abuse.

    Baseline, Week 10, Post-treatment Months 6 and 12

Secondary Outcomes (3)

  • Change in Beck Depression Inventory- II

    Baseline, Week 10, Post-treatment Months 6 and 12

  • Change in Beck Hopelessness Scale

    Baseline, Week 10, Post-treatment Months 6 and 12

  • Change in Self-Efficacy Scale for Battered Women

    Baseline, Week 10, Post-treatment Months 6 and 12

Study Arms (2)

Psychoeducational intervention (PEI)

EXPERIMENTAL

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

Behavioral: Psychoeducational intervention (PEI)

Enhanced Treatment as Usual

ACTIVE COMPARATOR

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

Behavioral: Enhanced treatment as usual (ETAU)

Interventions

Psychoeducational intervention (PEI)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.

Also known as: Theory of triadic influence
Psychoeducational intervention (PEI)
Enhanced treatment as usual (ETAU)BEHAVIORAL

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

Enhanced Treatment as Usual

Eligibility Criteria

Age18 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Hospital

Atlanta, Georgia, 30303, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33884617DERIVED

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Nadine J. Kaslow, PhD

    Emory University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nadine J. Kaslow, PhD

CONTACT

404-616-4757nkaslow@emory.edu

Barbara D'Orio, MD

CONTACT

404-616-4760bdorio@emory.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 15, 2008

First Posted

January 28, 2008

Study Start

March 1, 2008

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2028

Last Updated

November 12, 2024

Record last verified: 2024-11

Locations

US(1)