A New Clinical Model for the Engagement of Latinx Youth With Suicidal Behavior

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 12 to 18 years
• All sexes
• No healthy volunteers
• Child, Adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: A New Clinical Model for the Engagement of Latinx Youth With Suicidal Behavior and Their Families in a Culturally Centered CBT Treatment

Conditions

Suicide Ideation, Suicidal Behaviors, Depressive Symptoms

Being tested

Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB), SCBT-SB + CHW

Keywords

Suicidal Ideation, Suicide Attempt, Randomized controlled trial, adolescents, Latinx, Latina, Latino, Hispanic, cognitive behavioral therapy, depressive symptoms, community health workers

Medical subject headings

Depression, Suicidal Ideation, Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)Behavioural

  SCBT-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 + CHWBehavioural

  The 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.

   Measured: 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).

   Measured: 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).

   Measured: 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.

   Measured: Change from baseline to 6 months and baseline to 9 months.

5. Depressive symptoms by clinical interview

   Depressive symptoms using the Children's Depression Rating Scale-Revised (CDRS-R). The CDRS-R is a 17-item interview assessment of depressive symptoms for school aged children and adolescents, with item rating between 1 (no difficulties) to 5 or 7 (clinically significant difficulties). The minimum raw score is 17 and the maximum 113. A higher score means higher level of depressive symptoms. It has been proposed that a score of ≥40 indicates depressive symptomatology comparable to a diagnosis of depression, whereas a score ≤28 was often used as indicative of remission within trials.

   Measured: Change from baseline to 6 months and baseline to 9 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted19 Mar 2025
2. Study start28 Mar 2024
3. Primary completionJan 2027 (estimated)
4. Study completionJan 2027 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (3)Papers the sponsor has linked to this study.
• Other trials for Suicide IdeationStudies of the same condition, open and under way.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.