Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home
22 de mayo de 2014 actualizado por: Nerissa Bauer, Indiana University
Attention deficit hyperactivity disorder (ADHD) affects 8% of US youth.
Even though evidence shows medications are effective in reducing ADHD symptoms, many families experience ongoing parenting stress around parent-child interactions.
Children often have ongoing impairments in functioning.
ADHD is a common condition identified and managed by primary care pediatricians.
However current care in the clinic is not optimal to address parents' and children's needs around ADHD chronic care.
Time is the biggest barrier.
Group visits are a viable option to improve pediatric ADHD care, but requires extensive study.
The goal of this proposed study is to test the feasibility and effectiveness of the group visit model for ADHD management within pediatric primary care.
This study will be a randomized feasibility study that will generate important pilot data, as well as result in an innovative, exportable pediatric ADHD group curriculum for primary care practice.
Descripción general del estudio
Descripción detallada
The specific research aims of this proposal are:
Aim 1: Develop and test a group curriculum for parents of children (age 6 to 18 years) with ADHD to increase parental knowledge about ADHD and self-confidence in managing issues related to their child's functioning in school and home.
Aim 2: Develop and test a group curriculum for children (age 6 to 18 years) with ADHD to teach social and educational skills to improve adaptive functioning at home and school.
Aim 3: To assess any added benefits to the parents, children and providers (related to group visit logistics and satisfaction) the group visit model has over usual care.
Aim 4: To assess whether the group visit model can be done efficiently and effectively in the setting of an actual general pediatric practice.
Tipo de estudio
Intervencionista
Inscripción (Actual)
56
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
6 años a 18 años (Niño, Adulto)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- children with ADHD and their parents
- children receiving routine ADHD follow-up care at the study clinic
- if on medication, must be "stable" for 3 months and therefore not needing monthly clinic appointments to titrate medication
Exclusion Criteria:
- conduct disorder
- autism
- moderate to severe intellectual disability
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: ADHD Group Curriculum
Participants assigned to the group visit intervention agree to participate in 5 group visits every 3 months rather than individual ADHD follow-up visits to the clinic.
Parents and children participate in separate but simultaneously run groups.
Group portion is 60 minutes and then parent-child dyads complete individual visits for medication titration and physical exam.
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Study specific ADHD Group curriculum was designed and implemented for the study.
Parent curriculum included the following topics: What is ADHD, medications, educational advocacy, how to prevent behavioral issues and how to defuse common behavioral challenges and manage stress.
Child curriculum included the following topics: what is ADHD, social skills and friendships, handling school and organization skills, understanding feelings and managing negative emotions
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Sin intervención: Control
Participants continue to go to the clinic for 5 routine ADHD follow-up visits to the clinic every 3 months as usual clinical protocol.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of clinic visits during study period
Periodo de tiempo: 12 months
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Feasibility of group visit model was measured as number of visits to the clinic by chart review.
We also looked at the number of group visits a family attended based on the sign in sheet provided at the beginning of each session.
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12 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Parent-rated ADHD symptoms
Periodo de tiempo: Baseline
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Parents completed validated Vanderbilt Rating Scale regarding child's ADHD symptoms.
Measures response to ADHD treatment, primarily medication.
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Baseline
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Parent-rated ADHD symptoms
Periodo de tiempo: 12 months
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Parents complete validated Vanderbilt Rating Scale to report child symptoms of ADHD.
Used to assess response to treatment, usually medication.
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12 months
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Child functioning at home
Periodo de tiempo: Baseline
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Parent report of adaptive functioning of child in the home setting using the Home Situations Questionnaire
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Baseline
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Child functioning at home
Periodo de tiempo: 12 months
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Parents report of child's adaptive functioning in the home setting using the Home Situations Questionnaire.
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12 months
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Teacher report of child's ADHD symptoms
Periodo de tiempo: baseline
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teachers received the validated Vanderbilt rating scale to rate student's ADHD symptoms in the classroom.
Parents were given the tool at time of enrollment and asked to give to teacher as per clinical care guidelines.
Monitors impact of ADHD treatment, usually medication.
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baseline
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teacher report of child's ADHD symptoms in school
Periodo de tiempo: 12 months
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teachers received the validated Vanderbilt rating scale to rate student's ADHD symptoms in the classroom.
Parents were given the tool at time of enrollment and asked to give to teacher as per clinical care guidelines.
Monitors impact of ADHD treatment, usually medication.
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12 months
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Child functioning at school
Periodo de tiempo: baseline
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teachers were invited to provide rating of child's adaptive functioning at school.
Parent given the tool at time of enrollment and instructed to give to teacher as per clinical care guidelines.
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baseline
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teacher rating of child's functioning in school
Periodo de tiempo: 12 months
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teachers were invited to provide rating of child's adaptive functioning at school.
Parent given the tool at time of enrollment and instructed to give to teacher as per clinical care guidelines.
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12 months
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Quality of Life
Periodo de tiempo: baseline
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Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
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baseline
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Quality of Life
Periodo de tiempo: 12 months
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Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
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12 months
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Parenting self-efficacy
Periodo de tiempo: Baseline
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Parent reported sense of confidence using the Parenting Sense of Confidence Scale
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Baseline
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Parenting Self-efficacy
Periodo de tiempo: 12 months
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Parent-reported sense of confidence using Parenting Sense of Confidence scale
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12 months
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Parental knowledge, satisfaction towards medication treatment
Periodo de tiempo: baseline
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Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
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baseline
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Parent knowledge and satisfaction towards medication treatment
Periodo de tiempo: 12 months
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Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
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12 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Participant feedback about the curriculum
Periodo de tiempo: after each group visit over 365 days
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parents and children separately complete a short 4 question survey about what they liked, what they did not like, what they are excited about doing after the group visit and suggestions for improvement.
Data used to continually refine the curriculum.
At the 5th group visit, participants participated in informal discussion about the group visit model and overall satisfaction with the intervention
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after each group visit over 365 days
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Pediatric facilitator and staff feedback
Periodo de tiempo: at the end of each group visit over 365 days
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collected informal feedback and reflection about the process, barriers and positive experiences overall about the group visit model and impact on the clinical workflow, suggestions for improvement that was used to continually refine the model for quality improvement
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at the end of each group visit over 365 days
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Nerissa S Bauer, MD, MPH, Indiana University School of Medicine
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de junio de 2012
Finalización primaria (Actual)
1 de octubre de 2013
Finalización del estudio (Actual)
1 de noviembre de 2013
Fechas de registro del estudio
Enviado por primera vez
18 de mayo de 2014
Primero enviado que cumplió con los criterios de control de calidad
20 de mayo de 2014
Publicado por primera vez (Estimar)
23 de mayo de 2014
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
26 de mayo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
22 de mayo de 2014
Última verificación
1 de mayo de 2014
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 1204008526
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .