Terapia digital para problemas de comportamento
Alcance e escalabilidade da terapia digital para problemas de comportamento na infância
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Aim 1 is to evaluate the effectiveness of the UseIt! mHealth system as both a standalone and coach-assisted intervention compared to a control app condition. Aim 2 is to assess target (parent management training/cognitive behavioral therapy skill acquisition and use) engagement and validation. Aim 3 is to evaluate the effectiveness of the components of the UseIt! mHealth system. The investigators plan to recruit an anticipated total of 324 families for the study. Families will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted), or Group 3 (control app condition). Parents will use the app for four months before the administration of the post-treatment assessment. Parents will be trained to use the UseIt! mHealth system over the phone. The coach for the Group 2 condition will be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who will provide support to parents. The system is very user friendly and families can be trained in approximately 30 minutes. Assessments will take place at Baseline, Post (4 months from baseline), and 6-month follow-up. All assessments will be conducted online (Qualtrics survey links sent via email by research staff) and take approximately 1 hour to complete.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Bellefield Towers
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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:
- Males or females between the ages of 5-8 years
- Above the 90th percentile for Oppositional Defiant Disorder (ODD) and/or conduct disorders (CD) on the Vanderbilt Assessment Scale
- Residence with at least one parent/guardian at least 80% of the time
- Parent/legal guardian consent for participation
- Parent/guardian must have a smartphone device with daily internet access
Exclusion Criteria:
- A known preexisting behavioral or mental health diagnosis requiring alternative treatment (bipolar disorder, major depression, pervasive developmental disorder)
- Currently in treatment for childhood disruptive behavior
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Group 1: Standalone App
Standalone parenting app called UseIt! |
The UseIt! app is a parenting app with evidence-based parent management content. The app runs on both Android and iOS devices. It includes a digital library of parent management skills, a trouble-shooting guide, a behavior diary, a point counter, and a skills-alarm. |
|
Experimental: Group 2: App plus Coach
Standalone parenting app called UseIt! plus a coach. |
The UseIt! app is a parenting app with evidence-based parent management content. The app runs on both Android and iOS devices. It includes a digital library of parent management skills, a trouble-shooting guide, a behavior diary, a point counter, and a skills-alarm. The coach is be a bachelor's level paraprofessional with a degree in psychology or an allied discipline (e.g., social work) who provides support to parents. The coach will provide motivation and accountability but will not provide therapeutic/clinical support. The primary goal of the coach is to increase participant engagement with the UseIt! mHealth system. |
|
Comparador Ativo: Group 3: Control App
Control condition: mindfulness app called SmilingMind. |
The control app is a mindfulness app called SmilingMind. It is available for both Android and iOS devices. |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Knowledge of Effective Parenting Test (KEPT)
Prazo: Post assessment (4 months after baseline).
|
Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes. |
Post assessment (4 months after baseline).
|
|
Knowledge of Effective Parenting Test (KEPT)
Prazo: 6-month follow-up (10 months after baseline).
|
Average scores from the Knowledge of Effective Parenting Test (KEPT). This is a 21-item scale, with higher scores indicating better outcomes. |
6-month follow-up (10 months after baseline).
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Parenting Skill Use Diary (PSUD)
Prazo: Post assessment (4 months after baseline).
|
Average scores from the Parenting Skill Use Diary (PSUD). This is a proportion score (range 0 to 1), with higher scores indicating better outcomes. |
Post assessment (4 months after baseline).
|
|
Parenting Skill Use Diary (PSUD)
Prazo: 6-month follow-up (10 months after baseline).
|
Average scores from the Parenting Skill Use Diary (PSUD). This is a proportion score (range 0 to 1), with higher scores indicating better outcomes. |
6-month follow-up (10 months after baseline).
|
|
Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Prazo: Post assessment (4 months after baseline).
|
Average scores from the Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 24, with higher scores indicating worse outcomes. |
Post assessment (4 months after baseline).
|
|
Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Prazo: 6-month follow-up (10 months after baseline).
|
Average scores from the Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 24, with higher scores indicating worse outcomes. |
6-month follow-up (10 months after baseline).
|
|
Conduct Disorder Subscale of the Vanderbilt Assessment
Prazo: Post assessment (4 months after baseline).
|
Average scores from the Conduct Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 42, with higher scores indicating worse outcomes. |
Post assessment (4 months after baseline).
|
|
Conduct Disorder Subscale of the Vanderbilt Assessment
Prazo: 6-month follow-up (10 months after baseline).
|
Average scores from the Conduct Disorder Subscale of the Vanderbilt Assessment. Scores range from 0 to 42, with higher scores indicating worse outcomes. |
6-month follow-up (10 months after baseline).
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Oliver Lindhiem, PhD, University of Pittsburgh, Department of Psychiatry
Publicações e links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
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
- Transtornos Mentais, Desordem Mental
- Sintomas Comportamentais
- Distúrbios do Neurodesenvolvimento
- Transtornos de Déficit de Atenção e Comportamento Disruptivo
- Comportamento
- Comportamento problemático
- Transtorno Desafiador Opositivo
- Transtorno de conduta
- Comportamento infantil
- Instalações de saúde Força e serviços de trabalho
- Pessoal de saúde
- Doulas
Outros números de identificação do estudo
- STUDY22030138
- R01HD106930 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
All data collected for this project will be made available to other researchers for future data mining, following publication of primary findings at the conclusion of the study. The investigators will share data with other investigators within and outside the University of Pittsburgh upon submission of a standardized written request. All data sharing will follow the guidelines and rules of the NIH and our IRB. Data (both raw data and summary scores) will be shared electronically (secure digital file) as de-identified data.
Prazo de Compartilhamento de IPD
Following publication of primary findings at the conclusion of the study.
Critérios de acesso de compartilhamento IPD
To gain access, anyone not part of the original research protocol will submit a Data Analysis Request Form which requires elucidation of hypotheses to be tested and specific data requested. This form requires information about the investigator, including institutional affiliation, resume, proposed research, and conflict of interest statement. The investigator must document completion of the University of Pittsburgh Certification Program in Research Practice Fundamentals or a comparable training program at their own institution. Investigators outside the University of Pittsburgh must also complete a Data Use and Confidentiality Agreement before release of data to them.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
Informações sobre medicamentos e dispositivos, documentos de estudo
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