Evaluation of a Brief, Scalable Module to Mitigate Suicidal Ideation Among Youth (Phase 2)
This project embeds the "Give to Others" (GO) talk therapy module in a standard, outpatient therapy protocol to demonstrate target engagement in the context of ongoing clinical care and testing the ability of the GO module to engage the target in a rigorous randomized controlled trial (RCT) of the intervention. We will target perceived burdensomeness (PB) among 80 clinic-referred youths (ages 12-17) who experience subacute suicidal ideation (SI; i.e., positive suicide risk screen; stable safety status).
Visão geral do estudo
Status
Condições
Descrição detalhada
Youths will be recruited from the FIU Center for Children and Families (CCF) waitlist and the community at large, and will be randomized to one of the following 2 arms: a 12-session talk therapy and suicide risk management condition (control arm); and a 12-session therapy and suicide risk management condition plus the GO module (active arm). We hypothesize that youths receiving the GO module will have lower levels of PB and burden-related interpretation bias at mid-treatment and post-treatment compared with youths who receive the control arm. We also hypothesize that youths receiving the GO module will have lower levels of PB and burden-related interpretation bias at midtreatment and posttreatment compared to pre-treatment levels.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Jeremy Pettit, PhD
- Número de telefone: 305-348-1671
- E-mail: jpettit@fiu.edu
Estude backup de contato
- Nome: Victor Buitron, PhD
- Número de telefone: 305-348-9880
- E-mail: vbuitron@fiu.edu
Locais de estudo
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Florida
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Miami, Florida, Estados Unidos, 33199
- FIU Center for Children and Families
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Investigador principal:
- Victor Buitron, PhD
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Contato:
- Jeremy Pettit, PhD
- Número de telefone: 305-348-1671
- E-mail: jpettit@fiu.edu
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Contato:
- Victor Buitron, PhD
- Número de telefone: 305-348-9880
- E-mail: vbuitron@fiu.edu
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-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria
Adolescents must:
- be between ages 12 and 17 years
- score at or above the clinical cutoff on the Revised Child Anxiety and Depression Scale
- 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)
- be fluent in English and have available a parent who is fluent in English or Spanish
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: GO arm
Safety Planning + MATCH + GO module |
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. The GO Module is a brief cognitive behavioral intervention targeting youth burden-related beliefs. It consists of one primary session and brief follow-up. The MATCH Anxiety and Depression modules involve a transdiagnostic protocol that adapts to individual clinical needs for teens experiencing internalizing symptoms. Participants receive weekly cognitive-behavioral therapy sessions guided by manualized decision flowcharts to sequence treatment strategies. |
|
Comparador Ativo: Comparison Arm
Safety Planning + MATCH |
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. The MATCH Anxiety and Depression modules involve a transdiagnostic protocol that adapts to individual clinical needs for teens experiencing internalizing symptoms. Participants receive weekly cognitive-behavioral therapy sessions guided by manualized decision flowcharts to sequence treatment strategies. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Mid-treatment
Prazo: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
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). |
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
|
Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Mid-Treatment
Prazo: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk. |
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
|
Interpersonal Needs Questionnaire- Burdensomenes Scale- Self-report at Post-treatment
Prazo: From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
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). |
From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
|
Suicide Risk and Ideation Scale for Kids (S-RISK) - Child Report at Post-Treatment
Prazo: From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
The S-RISK measures the severity and intensity of suicidal thoughts and capability via 20 items. Higher scores indicate higher severity of suicide risk. |
From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Mid-Treatment
Prazo: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
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). |
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
|
Sentence Completion Task- Liability Index at Mid-Treatment
Prazo: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
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). |
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
|
Momentary Perceived Burdensomeness (mPB) Scale at Mid-Treatment
Prazo: From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
The mPB scale was developed to capture real-time states of perceived burdensomeness (Lühr et al., 2026). mPB includes two self-report items rated 1 to 5 with higher scores indicating higher levels of burdensomeness. |
From pre-treatment to mid-treatment (within one week of completing the assigned intervention at the midpoint of CBT)
|
|
Interpersonal Needs Questionnaire- Burdensomenes Scale- Parent report at Post-Treatment
Prazo: From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
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). |
From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
|
Sentence Completion Task- Liability Index at Post-Treatment
Prazo: From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
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). |
From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
|
Momentary Perceived Burdensomeness (mPB) Scale at Post-Treatment
Prazo: From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
The mPB scale was developed to capture real-time states of perceived burdensomeness (Lühr et al., 2026). mPB includes two self-report items rated 1 to 5 with higher scores indicating higher levels of burdensomeness. |
From pre-treatment to post-treatment (within one week of completing the final CBT session)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Victor Buitron, PhD, Florida International University
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IRB-26-0416
- R33MH137300 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
We will submit deidentified raw data to the National Institute of Mental Health (NIMH) Data Archive (NDA). The NDA is a data repository run by the NIMH that allows researchers studying mental health to collect and share deidentified information with each other. Our local data files will be coded, meaning we can track data back to subjects via a master key. However, we will upload de-identified electronic raw data collected from questionnaires and interviews to the NDA.
Prazo de Compartilhamento de IPD
The scientific community will have access to data when the award ends. NDA will make decisions about how long to preserve the data, but that data archive has not deleted any deposited data up to now.
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