Terapéutica digital para problemas de conducta
Alcance y escalabilidad de la terapéutica digital para problemas de conducta infantil
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).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- Bellefield Towers
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
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. |
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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 activo: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Knowledge of Effective Parenting Test (KEPT)
Periodo de tiempo: Post assessment (4 months after baseline).
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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).
|
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Knowledge of Effective Parenting Test (KEPT)
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Parenting Skill Use Diary (PSUD)
Periodo de tiempo: 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).
|
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Parenting Skill Use Diary (PSUD)
Periodo de tiempo: 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).
|
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Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Periodo de tiempo: 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).
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Oppositional Defiant Disorder Subscale of the Vanderbilt Assessment
Periodo de tiempo: 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).
|
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Conduct Disorder Subscale of the Vanderbilt Assessment
Periodo de tiempo: 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).
|
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Conduct Disorder Subscale of the Vanderbilt Assessment
Periodo de tiempo: 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
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Síntomas de comportamiento
- Trastornos del neurodesarrollo
- Trastornos por Déficit de Atención y Conducta Disruptiva
- Comportamiento
- Comportamiento problemático
- Trastorno de oposición desafiante
- Desorden de conducta
- Comportamiento infantil
- Instalaciones de atención médica Fuerza laboral y servicios
- Personal de salud
- Doulas
Otros números de identificación del estudio
- STUDY22030138
- R01HD106930 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan 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.
Marco de tiempo para compartir IPD
Following publication of primary findings at the conclusion of the study.
Criterios de acceso compartido de 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 información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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