A New Clinical Model for the Engagement of Latinx Youth With Suicidal Behavior
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-18
SponsorBradley Hospital
About this trial
This study will test a model of providing treatment to Latinx/Hispanic youth, who experience suicidal thoughts and behavior, and their caregivers. An affirmative and culturally relevant treatment will be provided to all youth and half of the families will be assigned to the additional support of a community health worker (CHW). Youth symptoms and family engagement to treatment will be followed for nine months. The potential benefit of adding the CHW intervention will be assessed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Latinx, defined as have been born in a Latin country or having at least one biological parent, grandparent or an ancestor that was born in a Latin country
SIQ-JR > 22 or endorsing any critical items (2, 3, 4, 7, 8, 9) with at least "about 1x/month"
CDI-II > 15 and endorsing "I think about killing myself but would not do it" OR "I think about killing myself."
PHQ-9 > 10 & endorsing the item "Thoughts that you would be better off dead, or of hurting yourself in some way" with a frequency of "several days" or greater or endorsing the item "Has there been a time in the past month when you have had serious thoughts about ending your life?
Disqualifiers
Behavioral (e.g., conduct disorder, or substance use disorder)
An eating disorder
Obsessive-compulsive disorder
A developmental issue (e.g., speech, occupational, families looking for assessments, treatment for autism) or a significant cognitive delay that may require specialized treatment adjustments.
Trial design
Design model
Parallel
Treatments tested in this trial
Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)
BehavioralSCBT-SB is a manualized psychosocial treatment protocol developed specifically with and for L/H youth with suicidal ideation and behaviors. Clinician, adolescents, and caregivers' manuals are available in both Spanish and English. SCBT-SB protocol's main conceptual framework and strategies are informed by Cognitive Behavioral Therapy concepts, psychoeducation, and adolescent parenting strategies. The intervention involves individual, caregivers, and family sessions. SCBT-SB, while maintaining the basic principles of CBT, was further developed to include developmental (e.g., identity), and cultural elements of L/H families (e.g., family communication, language). The protocol has two main phases. Phase 1, the Crisis Module, includes nine standard core sessions, and Phase 2, which proposes a flexible number of sessions, focused on the delivery of interchangeable coping skills modules and the acquisition of skills that reduce STB.
SCBT-SB + CHW
BehavioralThe New Clinical Model consist of one clinician delivering the SCBT-SB and one CHW per each family. The assigned clinician \& CHW will meet at the beginning of treatment to discuss their assigned case and will have follow-up meetings as needed and at a minimum, once monthly. CHWs will support family engagement in treatment. CHWs will assess each family's social needs and concerns about treatment. The CHW intervention will 1) Assess social determinants of mental health; 2) Provide referrals and serve as a bridge to other community resources; 3) Provide psychoeducation on mental health and services to decrease stigma; and 4) Follow-up and provide support on recommended actions.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: SCBT-SB (Only)Active comparator 1 intervention
Group B: New Clinical Model: SCBT-SB + Community Health WorkerExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Suicidal Ideation (SI)
Suicidal ideation measured using the Suicide Ideation Questionnaire-Junior (SIQ-JR), a self-report instrument of 15 items that measures severity of suicidal ideation as a continuous variable with established normative, reliability, and validity data for clinical and non-clinical adolescent samples. The minimum score is 0 and the maximum 90. A higher score represents increased severity and frequency of suicidal thoughts.
Time frame
Change from baseline to 6 months and baseline to 9 months.2
Suicide Attempts (SA)
Actual and interrupted suicide attempts (yes or no) using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Time frame
Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.3
Suicidal Events (SE)
SE is defined as yes or no to any suicide attempt plus any ER visits due to suicidal ideation, and suicidal threats based on patient's own report and medical record, or by information gathered from the Child and Adolescent Services Assessment (CASA).
Time frame
Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.4
Depressive symptoms by self-report
Level of depressive symptomatology using the Children Depression Inventory 2 (CDI-2). The CDI uses 27 items with a 4-point Likert type scale, the minimum score is 0 and the maximum 56. It evaluates symptoms such as depressive mood, hedonic capacity, vegetative sign, self-evaluation, and interpersonal behaviors. A higher score means higher level of depressive symptoms.
Time frame
Change from baseline to 6 months and baseline to 9 months.Sponsors and contacts
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Source ClinicalTrials.gov