Culturally Centered CBT Protocol for Suicidal Behaviors Among Youth in Mexico City

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorBradley Hospital

About this trial

This NIMH R34 award application proposes to conduct an adaptation, implementation, and pilot testing of the culturally centered CBT protocol, the Socio-Cognitive Behavioral Therapy for Suicidal Behaviors (SCBTSB), among suicidal youth in Mexico City, Mexico.

The research plan will (a) culturally adapt and contextualize the SCBT-SB for its implementation in the Mexican public health system, (b) pilot test the protocol through an RCT (SCBT-SB vs TAU; 60 patients and caregivers) and (c) evaluate the implementation process of the SCBT-SB and assess qualitatively possible factors that may promote or hinder its future uptake.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ages 12 to 17,

severe SI, defined as a score of 22 or above on the SIQ-JR or having made a SA or having a suicidal crisis (e.g., threats of attempting suicide) within the last 3 months

not be engaged in mental health services outside HPIJNN.

Disqualifiers

having a diagnosis of a psychotic disorder

having a diagnosis of substance use disorder, rated severe on the DSM-593 (i.e., endorsement of 6 or more symptoms),

not having sufficient cognitive ability to enter a psychotherapy service (whether reported by the parents or by data in the clinical record)

Trial design

Design model

Parallel

Treatments tested in this trial

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

    Behavioral

    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.

  • Treatment as usual

    Behavioral

    TAU consists of eclectic brief treatments, including some CBT or psychodynamic strategies that are applied with adolescents or in conjunction with the caregiver. In all cases, psychoeducation is provided to adolescents and their caregivers. Occasionally, they may be referred to some family therapy intervention. All treatments are brief therapy, provided by clinical psychologists and are intended to address the cognitive, emotional, and family factors that affect the adequate psychosocial functioning of the adolescent.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: SCBT-SB treatment modelExperimental treatment 1 intervention
Group B: Treatment as UsualActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Suicidal Ideation

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, 6 months to 9 months, and baseline to 9 months.
2

Depressive symptoms by self-report

Level of depressive symptomatology using the Revised Children's Anxiety and Depression Scale-25 (RCADS-25). The RCADS-25 is a 25-item scale that measures levels of anxiety and low mood (e.g. "I feel sad or empty"). The scale has two subscales (Total Anxiety and Total Depression) and an overall score. The Total Depression subscale consists of 10 items. All items assess the frequency of symptoms and are rated on a 4-point Likert scale from "0" (never) to "3" (always). The minimum score for the total depression subscale is 0 and the maximum 30. A higher score means higher level of depressive symptoms. Scoring the RCADS-25 uses converted scores on the total scale and both sub-scales divided into scoring.

Time frame
Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
3

Depressive symptoms by self-report

Patient Health Questionnaire-9 (PHQ-9) is a depression scale which scores each of the nine major depressive disorder DSM-IV criteria as "0" (not at all) to "3" (nearly every day). The minimum score is 0 and the maximum 27, with higher scores indicating more severe depressive symptoms. It has been validated for use in primary care and it is widely used to monitor the severity of depression symptoms and response to treatment.

Time frame
Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.
4

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.

Time frame
Change from baseline to 6 months, 6 months to 9 months, and baseline to 9 months.

Secondary outcomes

1

Suicide Attempts

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.

Other outcomes

Sponsors and contacts

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

Bradley Hospital

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator

Instituto Nacional de Psiquiatría Ramon de la Fuente Muñiz

Collaborator

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