- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT05223842
Family Promoting Positive Emotions Pilot Study
Targeting Positive Emotions to Prevent Emotional Disturbances in Children During COVID-19
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
Tennessee
-
Nashville, Tennessee, Estados Unidos, 37203
- Vanderbilt University
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion criteria for mothers:
- Age 18 and older who report at least subthreshold current depressive symptoms (> score of 8 on the Patient Health Questionnaire) and moderate COVID-19-related stress
- Can read and speak in English.
- Have access to a computer with a videoconferencing platform.
Inclusion criteria for children:
- Age 8-12 years who can participate with their biological mother who is 18 years or older that meets the above criteria.
- Can read and speak in English.
Exclusion criteria for mothers:
- Current substance use disorder.
- Intellectual disabilities.
- Diagnosis of mania or bipolar disorder.
- Diagnosis of a psychotic disorder (e.g., schizophrenia).
- Visual or hearing impairments that interfere with completing study measures and sessions.
Exclusion criteria for children:
- Diagnoses of autism spectrum disorders or developmental disorders.
- Intellectual disabilities.
- Diagnosis of mania or bipolar disorder.
- Diagnosis of a psychotic disorder (e.g., schizophrenia).
- Currently experiencing depressive symptoms.
- Visual or hearing impairments that interfere with completing study measures and sessions.
- Offspring of mothers who have previously participated in the study with another biological child.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Family Promoting Positive Emotions Group
Each dyad (mother and their child) will receive 8 sessions of promoting positive emotions intervention with a clinician for 8 weeks.
|
F-PPE is an 8-session dyadic intervention designed to enhance positive emotionality and buffer against the effects of stress on anhedonia in children.
The intervention will be administered online through videoconferencing sessions with a clinician to mothers and their children.
|
|
Comparador Ativo: Written Information Group
Mothers will be sent written information and resources on depression for 8 weeks over email.
|
Mothers assigned to the Written Information condition will receive email newsletters providing resources relevant to depression.
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Child perceived stress
Prazo: 8 weeks
|
The National Institutes of Health Toolbox Perceived Stress survey consists of 10 questions with options ranging in value from 1 to 5 to assess self-reported perceived stress for children (self- and parent-report). The minimum score is 10 and the maximum score is 50, with higher values meaning greater stress. Hypothesis 1a: Children in the F-PPE group will show lower post-intervention perceived stress compared to the written information group. |
8 weeks
|
|
Child emotional distress
Prazo: 8 weeks
|
The Patient-Reported Outcomes Measurement Information System (Anxiety, Depression, Anger) short form consists of questions with five response options ranging in value from 1 to 5 to assess self-reported anxiety, depression, anger and irritability for participants (parent, child, and parent report). Total scores on the emotional distress scales for children range from 33 to 165 for self-report and 26 to 130 for parent report, with higher scores reflect greater distress. Hypothesis 1b: Children in the F-PPE group will show lower post-intervention emotional distress compared to the written information group. |
8 weeks
|
|
Child positive affect
Prazo: 8 weeks
|
Positive affect will be assessed using the positive affect scale of the Positive and Negative Affect Schedule for Children administered through ecological momentary assessment over 10 days. Children rate their current affect on 5 items with a 1 to 5 scale for total scores from 5 to 25, with greater values reflecting greater positive affect. Hypothesis 2a: Children in the F-PPE group will show relative increases in daily positive affect from pre- to post-intervention compared to the written information condition. Hypothesis 2b: Changes in positive affect will partly account for F- PPE effects on child perceived stress and emotional distress. Hypothesis 2c: Changes in positive affect will partly account for F- PPE effects on child perceived stress and emotional distress. |
8 weeks
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Child reward learning
Prazo: 8 weeks
|
Reward learning will be measured using a Reinforcement Learning Task. The extent to which children begin to preferentially select the button that is more likely to be reinforced as a reward across the task will be used to quantify reinforcement learning. Hypothesis 3a: Children in the F-PPE group will show relative increases in reward learning from pre- to post-intervention compared to the written information condition. Hypothesis 3b: Changes in reward learning will partly account for F- PPE effects on child perceived stress and emotional distress. Hypothesis 3c: Changes in reward learning will partly account for F- PPE effects on child perceived stress and emotional distress. |
8 weeks
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Autumn J Kujawa, PhD, Vanderbilt University
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
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
- Processos Patológicos
- Doenças do Sistema Nervoso
- Manifestações Neurológicas
- Manifestações Neurocomportamentais
- Espectro da Esquizofrenia e Outros Transtornos Psicóticos
- Depressão
- Desordem depressiva
- Doença
- Transtornos Psicóticos
- Anedonia
- Transtornos Mentais, Desordem Mental
- Transtornos de Humor
- Sintomas Comportamentais
Outros números de identificação do estudo
- 211324
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Prazo de Compartilhamento de IPD
Critérios de acesso de compartilhamento IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .