Health TrialsbyHealthPanel

Safe Treatment for Emergency Presentation for Suicidal Ideation and Behavior in Youth

ConditionsSuicideSuicidalSelf-Harm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age13-24
SponsorUniversity of California, Los Angeles

About this trial

This randomized comparative effectiveness trial will compare two evidence-based approaches to emergency care for youth ages 13-24 who present to the Emergency Department (ED) with suicidal ideation or behavior. Outcomes will be monitored at baseline and at 3, 6 \& 12 month follow-up assessments.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age 13-24;

past-week suicidal behavior or ideation with plan or intent

Disqualifiers

symptoms or illness that precludes informed consent or engagement in study procedures (e.g., active psychosis; drug dependence, no locator information);

youth not fluent in English

parent not fluent in English or Spanish.

Trial design

Design model

Parallel

Treatments tested in this trial

  • SAFETY-A within usual ED Care

    Behavioral

    SAFETY-A is a single session collaborative, strengths-based, developmentally nuanced, cognitive-behavioral intervention (CBT) to increase safety and mental health treatment initiation. The therapist works with the youth and family (or significant other, SO) separately and together to build hope and reasons for living, develop a personal safety plan, increase protective supports; and increase motivation for and linkage to treatment.

  • Combined SAFETY-A within usual ED Care + CLASP Therapeutic Follow-Up Contacts

    Behavioral

    COMB, includes SAFETY-A within usual ED care plus CLASP therapeutic and caring follow-up contacts designed to strengthen safety and treatment initiation and engagement. Core functions of CLASP include: building hope/reducing hopelessness; enhancing social/family support; strengthening problem-solving; and increasing treatment initiation and engagement.

Treatment groups

1,600 Participants
are divided into 2 treatment groups
Group A: SAFETY-Acute within Usual ED CareActive comparator 1 intervention
Group B: CombinedActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Suicide Attempts: Primary Clinical Outcome

suicide attempts fatal, nonfatal, and interrupted

Time frame
Through 12 months of follow-up
2

Mental Health Treatment Initiation: Primary Service Use Outcome

initiation of mental health treatment after discharge from ED/hospital

Time frame
Observed through 12 months of follow-up, primary end point 6-month follow-up

Secondary outcomes

1

Self-Harm: Secondary Clinical Outcome

Any self-harm including suicidal, nonsuicidal, and ambiguous self-harm

Time frame
Through 12 months of follow-up
2

Treatment engagement: Secondary Service Use Outcome

Treatment dose received

Time frame
Through 12 months of follow-up

Other outcomes

1

Ordinal suicidality scale: Clinical

Ranges from nonsuicidal through ideation, behavior, attempts, and deaths

Time frame
Through 12 months of follow-up
2

Quality of life and functioning: Clinical

PROMIS Global Health Questionnaire , 0-100

Time frame
Change from baseline through 12 months of follow-up

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Los Angeles

Lead sponsor

Duke University

Collaborator

Brown University

Collaborator

University of Utah

Collaborator

Olive View-UCLA Education & Research Institute

Collaborator

RAND

Collaborator

Patient-Centered Outcomes Research Institute

Collaborator

Source ClinicalTrials.gov
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