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Completed

NCT Number: NCT06586645

Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth

This project is designed to test a brief therapy to reduce suicidal ideation among a diverse sample of youths ages 12 to 17 who experience anxiety or depression. The goal of the study is to conduct a clinical trial testing whether this therapy reduces suicidal ideation and related beliefs that one is a burden on others. This project will contribute to the field by potentially showing evidence supportive of a brief strategy to reduce suicidal ideation in a way that can be readily understood and used by mental health providers in the community.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

FIU Center for Children and Families

Miami, Florida, 33199, United States

About this study

This project tests the ability of a brief therapy module to engage youth perceived burdensomeness (PB) in a rigorous randomized controlled trial (RCT) of the intervention, the "Give to Others (GO)" module. The investigators will target PB among 60 ethnically/racially diverse clinic-referred youths (ages 12-17) who experience subacute suicide ideation SI (i.e., positive suicide risk screen; stable safety status). Youths will be recruited from the clinical and community settings and will be randomized to one of the following 2 arms: an assessment and suicide risk management condition (Safety Planning control arm); and a Safety Planning plus GO module condition. The investigators hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared with youths who receive the control arm. The investigators also hypothesize that youths receiving the GO module will have lower levels of PB at post-treatment compared to pre-treatment levels.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adolescents must:

  • be between ages 12 and 17 years
  • score at or above 4 on the Interpersonal Needs Questionnaire- Burdensomeness Scale
  • have a positive screen for suicide risk (i.e., endorsement of suicidal ideation via self-report or parent-report).

Exclusion criteria

For adolescents to be excluded, they must:

  • have cognitive impairment or developmental delay which does not allow for the completion of basic study procedures (i.e., reading and filling out questionnaires; talking to a clinician)
  • show imminent risk or a history of hurting themselves or others requiring intensive and restrictive services
  • be involved currently in a psychosocial treatment

Treatment and study plan

Safety planning

Behavioral

Safety planning is a standard suicide risk assessment and management protocol. This protocol involves determining level of risk based on current and prior suicidal thoughts and behavior, and then collaborative planning with youth and families for self-monitoring, self-regulation, help seeking, and suicide means restriction.

Give to Others Module

Behavioral

The "Give to Others" Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief phone follow-up.

Primary outcomes

  1. Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report

    Time frame: post-intervention (within one week of completing the assigned intervention)

    5-item youth self-ratings on perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 5 and 35. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).

Secondary outcomes

  1. Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report

    Time frame: post-intervention (within one week of completing the assigned intervention)

    5-item parent ratings on youth perceived burdensomeness over the past week. Each item is scored 1-7 (1 = not at all true for me; 7 = very true for me), yielding a total between 5 and 35. Higher scores indicate higher levels of perceived burdensomeness (worse outcome).

  2. Sentence Completion Task- Liability Index

    Time frame: post-intervention (within one week of completing the assigned intervention)

    28-item youth completed task assessing burden-related interpretation bias. Participants read 28 sentences indicative of posing a liability on others and select negatively- or positively-valenced words to complete each sentence. Each item is scored 0 or 1, yielding a total score between 0 and 28. Higher scores indicate higher levels of burden interpretation bias (worse outcome).

  3. Sentence Completion Task- Social Contribution Index

    Time frame: post-intervention (within one week of completing the assigned intervention)

    14-item youth completed task assessing contribution-related interpretation bias. Participants read 14 sentences indicative of contributing to others and select negatively- or positively-valenced words to complete each sentence. Each item is scored 0 or 1, yielding a total score between 0 and 14. Higher scores indicate higher levels of contribution interpretation bias (better outcome).

Sponsors and collaborators

Lead sponsor

Florida International University

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Jul 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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