SuicideNCT04278157
Culturally Centered CBT for Latinx Youth
A study testing Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) and Treatment as Usual in people with Suicide, run by Bradley Hospital at 2 sites in United States.
Trial summary
The primary aim of the proposed research is to test the effect of a culturally centered treatment protocol, the Socio-cognitive behavioral therapy (SCBT), versus Treatment as Usual on suicidal thoughts and attempts, and depressive symptoms, in a clinical sample of Latinx adolescents. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Suicide
- What is being tested?
- Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Feb 2020to 25 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
- Severe Suicidal Ideation (SI), defined as a score of 22 or above on the SIQ-JR or having made a Suicide Attempts (SA) within the last 3 months
- Caregivers and adolescents fluent in Spanish or English language and legal guardian willing to participate
Who cannot join
- psychosis
- substance use disorder, rated severe on the DSM-5
- cognitive impairment represented by an IQ below 85
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Hasbro Children's Hospital (Inpatient Psychiatric Unit)
Providence, Rhode Island, 02903
Bradley Hospital
Riverside, Rhode Island, 02915
About this study
Official title: A Culturally Centered CBT Protocol for Suicidal Ideation and Suicide Attempts Among Latinx Youth
The primary aim of the proposed research is to test the effect of a culturally centered treatment protocol, the Socio-cognitive behavioral therapy (SCBT), versus Treatment as Usual on suicidal thoughts and attempts, and depressive symptoms, in a clinical sample of Latinx adolescents. The study is trying to determine, if we take into account perspectives of Latin immigrant families and minority youth, whether better outcomes can be found for this high risk group.
Read the detailed description
The overall goal of this research program is to provide effective culturally relevant care to Latin families, and address the National Institute on Minority Health and Health Disparities (NIMHD) mission of reducing disparities in underserved and minority populations. Evidence-based and culturally centered treatments for Latinx teens (Latinx = gender inclusive term) with suicidal ideation and attempts (SIA) and their families are quite limited. Emerging evidence indicate that Cognitive behavioral therapy (CBT) is a promising treatment approach in reducing suicidal ideation and attempts in Non-Latinx White adolescents. However, culturally adapted treatments have been shown to benefit Latin families more that non-culturally adapted treatments. This study is innovative in its use of a culturally centered CBT treatment protocol (Socio-Cognitive Behavioral Therapy for Suicidal Behavior-SCBT-SB) to address the specific needs of Latinx teens and their families. The SCBT-SB, is a modified version of two CBT protocols, which addresses central issues in adolescent identity formation (e.g. ethnicity, sexual orientation), family interactions and communication, and parenting skills. The SCBT-SB was developed with Latinx youth with SIA in Puerto Rico and further modified for Latin families in the US. Feasibility of this modified version of the SCBT-SB was tested in the US by conducting a pilot randomized clinical trial (RCT) (n=46) of SCBT vs treatment-as-usual (TAU) with positive results. It was found that SCBT-SB was feasible to implement in a community mental health center with frontline therapists, acceptable to families, and showed reductions in suicidal ideation and depressive symptoms. The scientific premise of the proposed study is that immigration and acculturation (the process of assimilation to the host culture) and enculturation (maintaining cultural values and costumes) experiences have an impact on SIA in Latinx teens; and that personalization of an evidence-based treatment, according to cultural and immigration experiences, will result in better treatment outcomes than TAU. This application proposes a hybrid efficacy/effectiveness trial with 160 suicidal Latinx teens randomly assigned, following baseline assessment, to 2 treatment conditions, TAU and SCBT-SB. Follow-up assessment will take place at 3, 6 and 12 months after baseline. All treatment will take place at a community mental health clinic. The specific aims are: 1) To test the effect of the SCBT-SB versus TAU on suicidal ideation in a clinical sample of adolescents under conditions of strong external validity, and 2) To test the effect of the SCBT-SB versus TAU on depressive symptoms, given its high correlation with SIA. Exploratory aims are: 3) To examine the effect of SCBT-SB versus TAU on suicide attempts, and 4) To examine potential mediators (family environment) of treatment outcome. Successful completion of this study will positively impact treatment of Latinx immigrant adolescents at high risk of SIA in the US.
- Conditions
- Suicide
- Being tested
- Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB), Treatment as Usual
- Keywords
- Suicidal Ideation, Suicide Attempt, Latina, Latino, Latinx youth
- Medical subject headings
- Suicide, 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
The SCBT-SB is a manualized and flexible intervention that uses a modular approach to the treatment of adolescent suicidality. After the first mandatory module (Crisis module), and at the end of each subsequent module, the therapist works with the teen and caregivers to determine the next one. The Crisis Module is fixed and represent the intervention core skills with 9 sessions. The optional coping skills modules include Thoughts, Emotional Regulation, Family Communication, Social Interaction, Activity, Trauma, and Substance Use.
Treatment as UsualBehavioural
Therapy that typically consist of eclectic individual therapy including CBT, emphasizing psychoeducation and providing support, with occasional conjoint parent sessions or individual caregiver sessions. The treatment as usual primarily focuses on generating solutions to the adolescent and caregivers most urgent concerns.
| Study group | Role | What they receive |
|---|---|---|
| SCBT-SB | Experimental | A culturally centered CBT treatment protocol called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) Receives: Behavioral: Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) |
| Treatment as Usual | Active comparator | Treatment as usual is base on the standard care for teens and their parents under a community mental health center. Receives: Behavioral: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicidal ideation
Suicidal ideation measured using the Suicide Ideation Questionnaire-Junior (SIQ-JR), the minimum score is 0 and the maximum 90. A higher score represents increase severity and frequency of suicidal thoughts.
Measured: Change from baseline to 3 month, 6 month, and 12 month follow up points.
Depressive symptoms by self-report
Level of depressive symptomatology using the Children Depression Inventory 2 (CDI-2), the minimum score is 0 and the maximum 56. A higher score means higher level of depressive symptoms.
Measured: Change from baseline to 3 month, 6 month, and 12 month follow up points.
Depressive symptoms by clinical interview
Depressive symptoms using the Children's Depression Rating Scale-Revised (CDRS-R), the minimum raw score is 17 and the maximum 113. A higher score means higher level of depressive symptoms.
Measured: Change from baseline to 3 month, 6 month, and 12 month follow up points.
Secondary outcomes (3)
Suicide Attempts
Number of total actual and interrupted suicide attempts using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Change from baseline to 6 months follow-up
Suicide Attempts
Actual and interrupted suicide attempts (yes or no) using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Change from 6 months to 12 months follow-up
Suicide Attempts
Actual and interrupted suicide attempts (yes or no) using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Measured: Change from baseline to 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start27 Feb 2020
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies 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.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bradley Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brown University
- Responsible party
- Sponsor
- Investigators
- Yovanska Duarte-Velez, PhD, Principal investigator, Bradley Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278157
- Sponsor's protocol ID
- 1437564-1
- Status last verified
- Feb 2025
- First submitted
- 13 Feb 2020
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be made available to other researchers by request and as per NIH data sharing guidelines. The PI will also consult to anyone interested in replicating the intervention and study.
Publications
Duarte-Velez Y, Torres-Davila P, Spirito A, Polanco N, Bernal G. Development of a treatment protocol for Puerto Rican adolescents with suicidal behaviors. Psychotherapy (Chic). 2016 Mar;53(1):45-56. doi: 10.1037/pst0000044.
PubMed 26928136Duarte-Velez Y, Jimenez-Colon G, Jones RN, Spirito A. Socio-Cognitive Behavioral Therapy for Latinx Adolescent with Suicidal Behaviors: A Pilot Randomized Trial. Child Psychiatry Hum Dev. 2024 Jun;55(3):754-767. doi: 10.1007/s10578-022-01439-z. Epub 2022 Oct 1.
PubMed 36183051
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Culturally Centered CBT Protocol for Suicidal Ideation and Suicide Attempts Among Latinx Youth
- ClinicalTrials.gov ID
- NCT04278157
- Acronym / sponsor ID
- 1437564-1
- Conditions
- Suicide
- Keywords
- Suicidal Ideation, Suicide Attempt, Latina, Latino, Latinx youth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- Bradley HospitalUniversity, hospital or other
- Collaborators
- Brown University
- Study start
- 27 Feb 2020 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary aim of the proposed research is to test the effect of a culturally centered treatment protocol, the Socio-cognitive behavioral therapy (SCBT), versus Treatment as Usual on suicidal thoughts and attempts, and depressive symptoms, in a clinical sample of Latinx adolescents. The study is trying to determine, if we take into account perspectives of Latin immigrant families and minority youth, whether better outcomes can be found for this high risk group.
Detailed description
The overall goal of this research program is to provide effective culturally relevant care to Latin families, and address the National Institute on Minority Health and Health Disparities (NIMHD) mission of reducing disparities in underserved and minority populations. Evidence-based and culturally centered treatments for Latinx teens (Latinx = gender inclusive term) with suicidal ideation and attempts (SIA) and their families are quite limited. Emerging evidence indicate that Cognitive behavioral therapy (CBT) is a promising treatment approach in reducing suicidal ideation and attempts in Non-Latinx White adolescents. However, culturally adapted treatments have been shown to benefit Latin families more that non-culturally adapted treatments. This study is innovative in its use of a culturally centered CBT treatment protocol (Socio-Cognitive Behavioral Therapy for Suicidal Behavior-SCBT-SB) to address the specific needs of Latinx teens and their families. The SCBT-SB, is a modified version of two CBT protocols, which addresses central issues in adolescent identity formation (e.g. ethnicity, sexual orientation), family interactions and communication, and parenting skills. The SCBT-SB was developed with Latinx youth with SIA in Puerto Rico and further modified for Latin families in the US. Feasibility of this modified version of the SCBT-SB was tested in the US by conducting a pilot randomized clinical trial (RCT) (n=46) of SCBT vs treatment-as-usual (TAU) with positive results. It was found that SCBT-SB was feasible to implement in a community mental health center with frontline therapists, acceptable to families, and showed reductions in suicidal ideation and depressive symptoms. The scientific premise of the proposed study is that immigration and acculturation (the process of assimilation to the host culture) and enculturation (maintaining cultural values and costumes) experiences have an impact on SIA in Latinx teens; and that personalization of an evidence-based treatment, according to cultural and immigration experiences, will result in better treatment outcomes than TAU. This application proposes a hybrid efficacy/effectiveness trial with 160 suicidal Latinx teens randomly assigned, following baseline assessment, to 2 treatment conditions, TAU and SCBT-SB. Follow-up assessment will take place at 3, 6 and 12 months after baseline. All treatment will take place at a community mental health clinic. The specific aims are: 1) To test the effect of the SCBT-SB versus TAU on suicidal ideation in a clinical sample of adolescents under conditions of strong external validity, and 2) To test the effect of the SCBT-SB versus TAU on depressive symptoms, given its high correlation with SIA. Exploratory aims are: 3) To examine the effect of SCBT-SB versus TAU on suicide attempts, and 4) To examine potential mediators (family environment) of treatment outcome. Successful completion of this study will positively impact treatment of Latinx immigrant adolescents at high risk of SIA in the US.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCBT-SB | Experimental | Behavioral: Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)A culturally centered CBT treatment protocol called Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) |
| Treatment as Usual | Active comparator | Behavioral: Treatment as UsualTreatment as usual is base on the standard care for teens and their parents under a community mental health center. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
- Severe Suicidal Ideation (SI), defined as a score of 22 or above on the SIQ-JR or having made a Suicide Attempts (SA) within the last 3 months
- Caregivers and adolescents fluent in Spanish or English language and legal guardian willing to participate
Key exclusion criteria (3 listed)
- psychosis
- substance use disorder, rated severe on the DSM-5
- cognitive impairment represented by an IQ below 85
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)The SCBT-SB is a manualized and flexible intervention that uses a modular approach to the treatment of adolescent suicidality. After the first mandatory module (Crisis module), and at the end of each subsequent module, the therapist works with the teen and caregivers to determine the next one. The Crisis Module is fixed and represent the intervention core skills with 9 sessions. The optional coping skills modules include Thoughts, Emotional Regulation, Family Communication, Social Interaction, Activity, Trauma, and Substance Use. | Behavioural | SCBT-SB |
| Treatment as UsualTherapy that typically consist of eclectic individual therapy including CBT, emphasizing psychoeducation and providing support, with occasional conjoint parent sessions or individual caregiver sessions. The treatment as usual primarily focuses on generating solutions to the adolescent and caregivers most urgent concerns. | Behavioural | Treatment as Usual |
Primary outcome
Suicidal ideation
Time frame: Change from baseline to 3 month, 6 month, and 12 month follow up points.
Suicidal ideation measured using the Suicide Ideation Questionnaire-Junior (SIQ-JR), the minimum score is 0 and the maximum 90. A higher score represents increase severity and frequency of suicidal thoughts.
Depressive symptoms by self-report
Time frame: Change from baseline to 3 month, 6 month, and 12 month follow up points.
Level of depressive symptomatology using the Children Depression Inventory 2 (CDI-2), the minimum score is 0 and the maximum 56. A higher score means higher level of depressive symptoms.
Depressive symptoms by clinical interview
Time frame: Change from baseline to 3 month, 6 month, and 12 month follow up points.
Depressive symptoms using the Children's Depression Rating Scale-Revised (CDRS-R), the minimum raw score is 17 and the maximum 113. A higher score means higher level of depressive symptoms.
3 secondary outcomes
Suicide Attempts
Time frame: Change from baseline to 6 months follow-up
Suicide Attempts
Time frame: Change from 6 months to 12 months follow-up
Suicide Attempts
Time frame: Change from baseline to 12 months follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
- Background: PubMed 26928136Duarte-Velez Y, Torres-Davila P, Spirito A, Polanco N, Bernal G. Development of a treatment protocol for Puerto Rican adolescents with suicidal behaviors. Psychotherapy (Chic). 2016 Mar;53(1):45-56. doi: 10.1037/pst0000044.
- Background: PubMed 36183051Duarte-Velez Y, Jimenez-Colon G, Jones RN, Spirito A. Socio-Cognitive Behavioral Therapy for Latinx Adolescent with Suicidal Behaviors: A Pilot Randomized Trial. Child Psychiatry Hum Dev. 2024 Jun;55(3):754-767. doi: 10.1007/s10578-022-01439-z. Epub 2022 Oct 1.
- Individual participant dataSharing planned: Yes. Data will be made available to other researchers by request and as per NIH data sharing guidelines. The PI will also consult to anyone interested in replicating the intervention and study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yovanska Duarte-Velez, PhD principal investigator
Bradley Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB) and Treatment as Usual in people with Suicide, run by Bradley Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal ideation (time frame: Change from baseline to 3 month, 6 month, and 12 month follow up points.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04278157, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.