NCT03655470

Brief Summary

This study will examine the feasibility and acceptability of a program designed to conduct safety planning with youth in the juvenile justice system who are at risk for a suicide attempt and/or self-injury and to increase the possibility of them receiving outpatient mental health treatment. After training staff in the intervention, the investigators will pilot test the safety planning intervention and gather information on how well it worked on reducing self-harm, getting families to follow up with referrals for mental health care, and how often they attend treatment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

August 30, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 1, 2019

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 30, 2024

Completed
Last Updated

November 12, 2024

Status Verified

October 1, 2024

Enrollment Period

3.8 years

First QC Date

August 30, 2018

Results QC Date

December 13, 2023

Last Update Submit

October 17, 2024

Conditions

Keywords

suicidal behaviornonsuicidal self injuryadolescents

Outcome Measures

Primary Outcomes (1)

  • Change in Suicidal Ideation

    Score on Suicidal Ideation Questionnaire; higher is worse; range 0 to180

    Past month ideation at 1 and 3 month follow-up points

Secondary Outcomes (1)

  • Suicide Attempts

    3 months

Study Arms (2)

Safety Planning

EXPERIMENTAL

This brief intervention, consists of an in-person and follow-up phone call that are based on cognitive behavioral principles designed to help identify a concrete list of coping strategies and social supports that youth can utilize preceding or during a crisis to lower imminent risk of nonsuicidal self-injury or suicidal behavior.

Behavioral: Safety Planning

Standard Care

ACTIVE COMPARATOR

If a teen has a positive screen for suicide risk, the Probation Officer completes a "secondary screener" built into the court screening instrument to determine whether there is concern of current and/or imminent risk. If a teen endorses nonsuicidal self-injury more than once in the prior year, then the Probation Officer asks about frequency and severity. If there is ongoing concern of risk for self-injurious behavior, then the Probation Officer arranges for a crisis evaluation in the Emergency Department. If the teen is not judged to be at imminent risk, the Probation Officer makes a referral back to the current treatment provider or to a community mental health clinic. In either case, the parents and youth receive a packet with mental health resources

Behavioral: Standard care

Interventions

Safety PlanningBEHAVIORAL

Safety planning is an individual coping intervention to reduce suicidal risk in adolescents

Safety Planning
Standard careBEHAVIORAL

Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department

Standard Care

Eligibility Criteria

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

You may qualify if:

  • Legal guardian available to consent for juvenile's participation
  • Juvenile and parents are English or Spanish speaking
  • Juvenile flags in on the screening measure used in court with respect to suicidal ideation or nonsuicidal self-injury.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rhode Island Family Court

Providence, Rhode Island, 02903, United States

Location

Brown Univerity

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Suicidal IdeationSuicide, AttemptedSelf-Injurious Behavior

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

SuicideBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Limitations and Caveats

The major limitations were: 1) identification of participants eligible for the study in the various sections of the juvenile legal system with different frontline staff; and 2) follow-up rate for enrolled participants was no as high as expected due primarily to the fact that most participants exited the juvenile legal system at 3 months and therefore, at times, were unwilling to complete follow-up because they were no longer in the family court system.

Results Point of Contact

Title
Anthony Spirito, PI
Organization
Brown University

Study Officials

  • Anthony Spirito, PhD

    Brown U

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome assessors will be blind; participants will not be told to what condition they are assigned
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 group randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2018

First Posted

August 31, 2018

Study Start

January 1, 2019

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

November 12, 2024

Results First Posted

January 30, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

The final study protocol will contain the information necessary to reproduce the findings in other populations. The protocol will include a copy of this grant application including Specific Aims and study population; recruitment and enrollment information; the measures collected and coding of the measures and subscales; the clinician intervention procedures; data analyses; syntax for data summary, and data analysis plans

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
1 year after completion of all follow-up data
Access Criteria
Contact PI

Locations