NCT02227160

Brief Summary

The investigator is conducting a hybrid efficacy-effectiveness randomized controlled trial with low-income African American suicide attempters. Guided by the Theory of Triadic Influence (TTI), this pilot randomized controlled trial aims:

  1. 1.to determine if psychosocial group intervention (PGI) is more effective than enhanced treatment as usual (ETAU) in reducing suicidal behavior (ideation, attempts; primary outcome) and improving its correlates (depressive symptoms, hopelessness, quality of life) (secondary outcomes) in low-income African Americans with a recent attempt.
  2. 2.to determine if PGI is more effective than ETAU at bolstering intrapersonal (I), social/situational (SS), and cultural/environmental (CE) risk and protective factors that mediate the condition-suicidal behavior and correlates link and thus serve as mechanisms of change.
  3. 3.to determine I, SS, and CE variables that moderate the condition-suicidal behavior link and thus serve as predictors of intervention outcome.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started May 2016

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 27, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

December 15, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

August 26, 2014

Last Update Submit

December 13, 2017

Conditions

DepressionMental IllnessSuicideSuicidal Ideation

Outcome Measures

Primary Outcomes (1)

  • Change in scores on Beck Scale for Suicidal Ideation

    Beck Scale for Suicidal Ideation is a 21-item instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide.

    Baseline, post-therapy, 6 months and 12 months after therapy

Secondary Outcomes (4)

  • Change in scores on Beck Depression Inventory - II

    Baseline, post-therapy, 6 months and 12 months after therapy

  • Change in scores on Beck Hopelessness Scale

    Baseline, post-therapy, 6 months and 12 months after therapy

  • Change in scores on WHO Quality of Life Brief Instrument

    Baseline, post-therapy, 6 months and 12 months after therapy

  • Patient Satisfaction

    12 months

Other Outcomes (28)

  • Change in the Symptom Checklist 90-Revised (SCL 90-R) scale

    Baseline, post-therapy, 6 months and 12 months after therapy

  • Change in scores for Alcohol Use Disorders Identification Test

    Baseline, post-therapy, 6 months and 12 months after therapy

  • Change in scores on Drug Abuse Screening Test

    Baseline, post-therapy, 6 months and 12 months after therapy

  • +25 more other outcomes

Study Arms (2)

Psychosocial group intervention

EXPERIMENTAL

Subjects will seek outpatient counseling, support groups, in addition to 10 weekly group meetings

Behavioral: 10 weekly group meetingsBehavioral: Outpatient counseling and support groups

Control

ACTIVE COMPARATOR

Subjects will seek outpatient counseling and support groups only

Behavioral: Outpatient counseling and support groups

Interventions

10 weekly group meetingsBEHAVIORAL

10 weekly group meetings with up to five other men and women at Grady Health System

Psychosocial group intervention
Outpatient counseling and support groupsBEHAVIORAL

Usual mental health care

ControlPsychosocial group intervention

Eligibility Criteria

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

You may qualify if:

  • yrs old
  • patients who seek treatment at Grady Health System (GHS) after a suicide attempt
  • African American
  • speak English

You may not qualify if:

  • cognitive impairments
  • medical instability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

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

DepressionMental DisordersSuicideSuicidal Ideation

Interventions

Self-Help Groups

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-Injurious Behavior

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • Nadine Kaslow, PhD

    Emory University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nadine Kaslow PhD

Study Record Dates

First Submitted

August 26, 2014

First Posted

August 27, 2014

Study Start

May 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

December 15, 2017

Record last verified: 2017-12

Locations

US(1)