Family ConflictNCT03221530
Early Intervention for Suicide Risk Among Immigrant Youth
A study testing Early Intervention for Suicide Risk Among Immigrant Youth in people with Family Conflict and Suicidal Ideation, run by Massachusetts General Hospital.
Trial summary
The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. The intervention will focus on reducing suicide risk by reducing family conflict and intergenerational cultural conflict and improving parent-child… Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Family Conflict, Suicidal Ideation
- What is being tested?
- Early Intervention for Suicide Risk Among Immigrant Youth
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2019to 1 Aug 2022
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Latino
- First generation (foreign-born) or second-generation (at least one parent foreign-born) immigrant
- 12 to 15 years old
- Speaks English or Spanish
- Reports current suicidal ideation with no plan, past-year suicidal ideation, or a suicide plan more than three months prior OR has a CAT-SS score>34
Who cannot join
- Suicide attempt in the past three months
- Endorses psychotic symptoms on a pre-study screener
- Has severe major depressive disorder
- Has a prior diagnosis of severe intellectual disability
- Receiving individual or family therapy
Trial locations and contacts
No sites are listed yet.
About this study
The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. The intervention will focus on reducing suicide risk by reducing family conflict and intergenerational cultural conflict and improving parent-child communication. The investigators will first develop the 8-session preventive intervention with quantitative data from analysis of existing longitudinal studies and qualitative feedback from Latino youth and their caregivers, clinicians, administrators, and research consultants, as well as results from initial pilot testing of the intervention. The investigators will then conduct a pilot randomized trial with 40 adolescents and their families to test feasibility, acceptability, and impact on intervention targets. Successful development of the intervention would improve mental health outcomes for a growing and underserved portion of the U.S. population.
Read the detailed description
Suicide is the second-leading cause of death among adolescents, with rates increasing between 1999 and 2014. Family-based preventive interventions demonstrate promise for reducing suicide risk among adolescents, and are particularly relevant for addressing suicide risk factors specific to immigrant youth, who comprise one-fourth of the U.S. population under 18. The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. In the first phase of intervention development, quantitative and qualitative data will be used to develop and if necessary refine a new family based preventive intervention (Early Intervention for Suicide Risk among Immigrant Youth, EISR-I). The investigators will then test the intervention in a pilot case series in order to finalize assessment and intervention protocols. In the second phase, the investigators will pilot test the preventive intervention, delivered by mental health clinicians to 1st and 2nd generation Latino/a early adolescents and their families, in order to assess feasibility, acceptability, and impact on the intervention targets (i.e. a positive signal of the intervention) on the study population. Twenty families will be randomized to receive the 8-session intervention and twenty will receive enhanced usual care including a safety planning and feedback session.
- Conditions
- Family Conflict, Suicidal Ideation
- Being tested
- Early Intervention for Suicide Risk Among Immigrant Youth, Enhanced usual care
- Keywords
- suicidal ideation, mental health, adolescent, Latino, immigrant
- Medical subject headings
- Suicidal Ideation, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Intervention for Suicide Risk Among Immigrant YouthBehavioural
The EISR-I intervention includes family treatment engagement, shared problem definition, and sessions designed to address family cohesion, communication, and conflict resolution.
Enhanced usual careBehavioural
This intervention includes a session with the family to engage in safety planning and provide feedback on their baseline assessment data.
| Study group | Role | What they receive |
|---|---|---|
| EISR-I | Experimental | Participants in the Early Intervention for Suicide Risk Among Immigrant Youth (EISR-I) family-based intervention will attend 8 in-person sessions with at least one parent/guardian. Receives: Behavioral: Early Intervention for Suicide Risk Among Immigrant Youth |
| Enhanced usual care | Active comparator | Participants in the usual care arm will receive a safety planning and assessment feedback session from the research team and will receive usual care in the behavioral health clinic where the study takes place. Receives: Behavioral: Enhanced usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia Suicide Severity Rating Scale Screener (C-SSRS); change from baseline at multiple time points
A self-report scale of suicidal ideation, plans and attempts
Measured: baseline, 3, 6, and 12 months
Secondary outcomes (4)
Computerized Adaptive Test - Suicide Scale (CAT-SS); change from baseline at multiple time points
A computerized adaptive suicide scale that provides a continuous self-report measure of suicide risk
Measured: baseline, 3, 6, and 12 months
Family Relationship Index; change from baseline at multiple time points
A self-report measure that provides an overall index of the quality of the family environment, as well as subscores that reflect family cohesion, expressiveness, and conflict.
Measured: baseline, 3, 6, and 12 months
Family Cultural Conflict Scale; change from baseline at multiple time points
A self-report measure of conflicts within a family related to cultural values and practices.
Measured: baseline, 3, 6, and 12 months
Parent-Adolescent Communication Scale; change from baseline at multiple time points
A self-report measure of the quality of communication between adolescent and parent.
Measured: baseline, 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start1 Oct 2019 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Family ConflictStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiara Alvarez, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03221530
- Sponsor's protocol ID
- 2017P001429
- Status last verified
- Aug 2019
- First submitted
- 16 Jul 2017
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intervention for Suicide Risk Among Immigrant Youth
- ClinicalTrials.gov ID
- NCT03221530
- Acronym / sponsor ID
- 2017P001429
- Conditions
- Family Conflict, Suicidal Ideation
- Keywords
- suicidal ideation, mental health, adolescent, Latino, immigrant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 18 Jul 2017 (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 purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. The intervention will focus on reducing suicide risk by reducing family conflict and intergenerational cultural conflict and improving parent-child communication. The investigators will first develop the 8-session preventive intervention with quantitative data from analysis of existing longitudinal studies and qualitative feedback from Latino youth and their caregivers, clinicians, administrators, and research consultants, as well as results from initial pilot testing of the intervention. The investigators will then conduct a pilot randomized trial with 40 adolescents and their families to test feasibility, acceptability, and impact on intervention targets. Successful development of the intervention would improve mental health outcomes for a growing and underserved portion of the U.S. population.
Detailed description
Suicide is the second-leading cause of death among adolescents, with rates increasing between 1999 and 2014. Family-based preventive interventions demonstrate promise for reducing suicide risk among adolescents, and are particularly relevant for addressing suicide risk factors specific to immigrant youth, who comprise one-fourth of the U.S. population under 18. The purpose of this project is to develop and test a family-based preventive intervention for suicide risk among 1st and 2nd generation immigrant Latino/a adolescents. In the first phase of intervention development, quantitative and qualitative data will be used to develop and if necessary refine a new family based preventive intervention (Early Intervention for Suicide Risk among Immigrant Youth, EISR-I). The investigators will then test the intervention in a pilot case series in order to finalize assessment and intervention protocols. In the second phase, the investigators will pilot test the preventive intervention, delivered by mental health clinicians to 1st and 2nd generation Latino/a early adolescents and their families, in order to assess feasibility, acceptability, and impact on the intervention targets (i.e. a positive signal of the intervention) on the study population. Twenty families will be randomized to receive the 8-session intervention and twenty will receive enhanced usual care including a safety planning and feedback session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EISR-I | Experimental | Behavioral: Early Intervention for Suicide Risk Among Immigrant YouthParticipants in the Early Intervention for Suicide Risk Among Immigrant Youth (EISR-I) family-based intervention will attend 8 in-person sessions with at least one parent/guardian. |
| Enhanced usual care | Active comparator | Behavioral: Enhanced usual careParticipants in the usual care arm will receive a safety planning and assessment feedback session from the research team and will receive usual care in the behavioral health clinic where the study takes place. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Latino
- First generation (foreign-born) or second-generation (at least one parent foreign-born) immigrant
- 12 to 15 years old
- Speaks English or Spanish
- Reports current suicidal ideation with no plan, past-year suicidal ideation, or a suicide plan more than three months prior OR has a CAT-SS score>34
Key exclusion criteria (5 listed)
- Suicide attempt in the past three months
- Endorses psychotic symptoms on a pre-study screener
- Has severe major depressive disorder
- Has a prior diagnosis of severe intellectual disability
- Receiving individual or family therapy
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 |
|---|---|---|
| Early Intervention for Suicide Risk Among Immigrant YouthThe EISR-I intervention includes family treatment engagement, shared problem definition, and sessions designed to address family cohesion, communication, and conflict resolution. | Behavioural | EISR-I |
| Enhanced usual careThis intervention includes a session with the family to engage in safety planning and provide feedback on their baseline assessment data. | Behavioural | Enhanced usual care |
Primary outcome
Columbia Suicide Severity Rating Scale Screener (C-SSRS); change from baseline at multiple time points
Time frame: baseline, 3, 6, and 12 months
A self-report scale of suicidal ideation, plans and attempts
4 secondary outcomes
Computerized Adaptive Test - Suicide Scale (CAT-SS); change from baseline at multiple time points
Time frame: baseline, 3, 6, and 12 months
Family Relationship Index; change from baseline at multiple time points
Time frame: baseline, 3, 6, and 12 months
Family Cultural Conflict Scale; change from baseline at multiple time points
Time frame: baseline, 3, 6, and 12 months
Parent-Adolescent Communication Scale; change from baseline at multiple time points
Time frame: baseline, 3, 6, and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Family Conflict
Not yet recruiting
Internet Intervention for Well-Being and Work-Family Conflict in Dual-Earner Couples
Psychological Stress, Work-Family Conflict
Not yet recruiting
Nonviolent Communication Plus Personalised E-message for Parents
Family Conflict, Relationship, Parent Child
Recruiting
GlycoQuest: An AI-Adaptive CGM-Integrated Serious Game for Pediatric Type 1 Diabetes
Type 1 Diabetes Mellitus (T1DM), Diabetes Distress
Not yet recruiting
Addressing Relational and Communication Conflicts in Families With Adolescents.
Relational and Communication Conflicts Between Adolescents and Their Families
Recruiting
Improving Outcomes in Social Services Through Routine Outcome Monitoring and Systematic Client Feedback
Substance Use Disorders, Criminal Behavior
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.
Questions about this trial
What is this clinical trial studying?
A study testing Early Intervention for Suicide Risk Among Immigrant Youth in people with Family Conflict and Suicidal Ideation, run by Massachusetts General Hospital.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiara Alvarez, PhD (617-724-1237, kalvarez2@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Suicide Severity Rating Scale Screener (C-SSRS); change from baseline at multiple time points (time frame: baseline, 3, 6, and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2019; AzTrials last refreshed its copy on 31 Oct 2026.