NCT01748760

Brief Summary

This study is to develop an adjunctive intervention for acutely suicidal adolescents who have been admitted to a psychiatric inpatient unit. The study intervention is comprised of: 1) two to three individual sessions delivered in an inpatient setting or immediately upon discharge; 2) one family session; 3) six months of follow-up phone interventions. The investigators hypothesize that those who receive the study intervention will have lower rates of suicide events and greater decreases in suicidal ideation after six months.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2012

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 13, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
3 years until next milestone

Results Posted

Study results publicly available

January 13, 2017

Completed
Last Updated

January 13, 2017

Status Verified

September 1, 2016

Enrollment Period

1.3 years

First QC Date

December 11, 2012

Results QC Date

February 3, 2016

Last Update Submit

November 17, 2016

Conditions

Keywords

Suicide AttemptsSuicidal Ideation

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Who Repoorted a Suicide Event

    A suicide event is either a suicide attempts (actual, aborted, interrupted), or emergency interventions to intercede an attempt.

    6 months

Study Arms (2)

CLASP-A intervention

EXPERIMENTAL

Adolescent participants and parents will receive adjunctive psychosocial intervention.

Behavioral: CLASP-A intervention

Treatment as Usual

ACTIVE COMPARATOR

Adolescent participants and parents will not receive study intervention

Other: Treatment as Usual

Interventions

Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.

CLASP-A intervention

Referral to outpatient treatment as part of routine discharge planning.

Treatment as Usual

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Admission to an inpatient unit due to suicide risk
  • English speaking

You may not qualify if:

  • Active psychosis
  • Cognitive Disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

MeSH Terms

Conditions

SuicideSuicide, AttemptedSuicidal Ideation

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Results Point of Contact

Title
Shirley Yen, Ph.D.
Organization
Brown University

Study Officials

  • Shirley Yen, Ph.D.

    Brown University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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
Assistant Professor (Research)

Study Record Dates

First Submitted

December 11, 2012

First Posted

December 13, 2012

Study Start

October 1, 2012

Primary Completion

January 1, 2014

Study Completion

January 1, 2014

Last Updated

January 13, 2017

Results First Posted

January 13, 2017

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will share

Please contact PI for data.

Locations