Targeting Burdensomeness Among Clinic Referred Youth
12 de maio de 2021 atualizado por: Florida International University
This study will develop and pilot test a novel intervention module targeting perceived burdensomeness toward others in 30 clinic referred youths who experience anxiety or depression and elevated levels of burdensomeness.
All participants will be assigned to receive the intervention in this open trial.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Suicidal ideation is prevalent and impairing in youth, with approximately 15% of high school students reporting seriously considering a suicide attempt and making a specific plan for suicide in the past 12 months.
Substantial evidence documents perceived burdensomeness towards others, or the belief that one is a burden or drain on others, as a risk factor for suicide ideation in youth.
This evidence highlights the potential promise of perceived burdensomeness as a novel intervention target to prevent suicide ideation in youth.
The current study will develop and preliminary evaluate a novel, brief behavioral treatment module targeting perceived burdensomeness in youth that can be embedded within existing psychosocial treatments.
The study will use an open trial design.
The first aim of this proposal is to develop a novel, brief psychosocial intervention module (the GIVE module) targeting perceived burdensomeness towards others that can be embedded within existing CBT protocols for youth internalizing problems.
The second aim is to collect data relevant to client satisfaction and reductions in perceived burdensomeness.
Participants will be N=30 clinic-referred youth ages 10 to 17 years with anxiety or depressive disorders in a university-based research clinic, who display elevated levels of perceived burdensomeness.
In the context on ongoing CBT for anxiety or depression, participants will complete the GIVE module at sessions 6 and 7 of the CBT protocol.
It is hypothesized that perceived burdensomeness will be significantly lower after the GIVE module is administered, and that client satisfaction will be high.
Data collected in this study will provide the foundation for a subsequent randomized controlled trial of the GIVE module.
Tipo de estudo
Intervencional
Inscrição (Real)
18
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
Florida
-
Miami, Florida, Estados Unidos, 33199
- Florida International University Center for Children and Families
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
10 anos a 17 anos (Filho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Clinical diagnosis of an anxiety disorder, persistent depressive disorder, or major depressive disorder
- Score > 4 on the youth self-report Interpersonal Needs Questionnaire- Perceived Burdensomeness Scale
Exclusion Criteria:
- Clinical diagnosis of a Psychotic Disorder, Autism Spectrum Disorder or Intellectual Disability
- Show high risk of imminent self-injurious behaviors
- Be involved currently in another behavioral treatment
- Not live with a primary caregiver who is legally able to give consent for the youth's participation
- Be a victim of previously undisclosed abuse requiring investigation or ongoing supervision by the Department of Children and Families.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: GIVE module
The GIVE module consists of one 50-minute treatment session and a second partial session (15-20 minutes) embedded within a larger cognitive behavioral treatment (CBT) protocol for anxiety or depression.
The GIVE module uses cognitive behavioral principles to target youth's beliefs that they are a burden or drain on others.
|
The GIVE Module is a brief cognitive behavioral intervention targeting youths' beliefs that they are a burden or drain on others.
It consists of two sessions embedded within a larger CBT protocol for anxiety or depression.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
6-item Youth Perceived Burdensomeness Subscale of the Interpersonal Needs Questionnaire
Prazo: post-intervention (within one week of completing the GIVE Module)
|
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 6 and 42.
Higher scores indicate higher levels of perceived burdensomeness (worse outcome).
|
post-intervention (within one week of completing the GIVE Module)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
10-item Youth Rated Warmth Subscale of the Child Report of Parental Behavior Inventory
Prazo: post-intervention (within one week of completing the GIVE Module)
|
Youth ratings on parental warmth over the past week.
Each of 10 items is scored 1-3 (1 = not like parent; 3 = a lot like parent), yielding a total score of 10 to 30.
Higher scores indicate higher levels of parental warmth (better outcome).
|
post-intervention (within one week of completing the GIVE Module)
|
|
10-item Parent Rated Warmth Subscale of the Parent Report of Parental Behavior Inventory
Prazo: post-intervention (within one week of completing the GIVE Module)
|
Parent self-ratings on parental warmth over the past week.
Each of 10 items is scored 1-3 (1 = not like me; 3 = a lot like me), yielding a total score of 10 to 30.
Higher scores indicate higher levels of parental warmth (better outcome).
|
post-intervention (within one week of completing the GIVE Module)
|
|
41-item Youth Rated Screen for Child Anxiety Related Emotional Disorders
Prazo: post-intervention (within one week of completing the GIVE Module)
|
Youth self-ratings on anxiety symptom severity.
Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82.
Higher scores indicate higher levels of anxiety (worse outcome).
|
post-intervention (within one week of completing the GIVE Module)
|
|
41-item Parent Rated Screen for Child Anxiety Related Emotional Disorders
Prazo: post-intervention (within one week of completing the GIVE Module)
|
Parent ratings on youth anxiety symptom severity.
Each item is scored 0-2 (0 = not true; 2 = very true), yielding a total score of 0 to 82.
Higher scores indicate higher levels of anxiety (worse outcome).
|
post-intervention (within one week of completing the GIVE Module)
|
|
28-item Youth-rated Children's Depression Inventory - 2
Prazo: post-intervention (within one week of completing the GIVE Module)
|
Youth self-ratings on depressive symptom severity.
Each item is scored 0-2, yielding total scores of 0 to 56, with higher scores corresponding to more severe symptoms.
|
post-intervention (within one week of completing the GIVE Module)
|
|
17-item Parent Rated Children's Depression Inventory - 2
Prazo: post-intervention (within one week of completing the GIVE Module)
|
Parent ratings on youth depressive symptom severity.
Each item is scored 0-3, yielding total scores of 0 to 51, with higher scores corresponding to more severe symptoms.
|
post-intervention (within one week of completing the GIVE Module)
|
|
8-item Youth Rated Client Satisfaction Questionnaire
Prazo: post-intervention (within one week of completing the GIVE Module)
|
Youth ratings of satisfaction with the GIVE module.
Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32.
Higher scores indicate higher satisfaction (better outcome).
|
post-intervention (within one week of completing the GIVE Module)
|
|
8-item Parent Rated Client Satisfaction Questionnaire
Prazo: post-intervention (within one week of completing the GIVE Module)
|
Parent ratings of satisfaction with the GIVE module.
Each item is score 1-4 (1 = quite dissatisfied; 4 = very satisfied), yielding total scores of 8-32.
|
post-intervention (within one week of completing the GIVE Module)
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
20 de março de 2019
Conclusão Primária (Real)
30 de dezembro de 2020
Conclusão do estudo (Real)
30 de dezembro de 2020
Datas de inscrição no estudo
Enviado pela primeira vez
18 de dezembro de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
18 de dezembro de 2018
Primeira postagem (Real)
19 de dezembro de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de junho de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de maio de 2021
Última verificação
1 de maio de 2021
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 1F31MH116603 (Concessão/Contrato do NIH dos EUA)
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .