NCT02313753

Brief Summary

The purpose of this study is to evaluate the utility of the Coping Long Term with Active Suicide Program (CLASP) for reducing suicidal behavior.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
224

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

December 1, 2014

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

December 5, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2014

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

6.3 years

First QC Date

December 5, 2014

Last Update Submit

June 4, 2021

Conditions

Suicide

Outcome Measures

Primary Outcomes (1)

  • A composite composed of the number of participants with either a suicide attempt or death by suicide

    As assessed by both the Columbia Suicide Severity Rating Scale and record review

    52 weeks following discharge from hospital

Study Arms (2)

SAFE

ACTIVE COMPARATOR

Safety Assessment and Follow-up Evaluation Protocol

Behavioral: SAFE

CLASP

EXPERIMENTAL

Coping Long Term with Active Suicide Program Protocol

Behavioral: CLASP

Interventions

CLASPBEHAVIORAL
CLASP
SAFEBEHAVIORAL
SAFE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Current patient at Butler Hospital
  • Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS
  • Age \> 18 years
  • Have a reliable telephone
  • Ability to speak, read, and understand English well to complete the procedures of the study

You may not qualify if:

  • Current psychotic symptoms severe enough to impair study participation
  • Participation in a treatment program with established efficacy in preventing suicidal behavior
  • Cognitive impairment which would interfere with adequate participation in the project (MMSE\< 20).
  • \. Currently in state custody or pending legal action 5. Already enrolled current or previous CLASP trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Psychosocial Research

Study Record Dates

First Submitted

December 5, 2014

First Posted

December 10, 2014

Study Start

December 1, 2014

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

June 7, 2021

Record last verified: 2021-06

Locations

US(1)