Web-MAP Intervention for Youth With Sickle Cell Disease (Web-MAP)
WEB MAP Intervention for Youth With Sickle Cell Disease
The proposed study will determine whether the efficacy of WebMAP cognitive behavioral therapy (CBT) treatment study generalizes to pediatric sickle cell disease (SCD), and explore whether the intervention is feasible and acceptable to this population. Feasibility of multi-institutional recruitment from sickle cell centers will also be determined. The short-term goal is to produce preliminary data to apply for an R01 proposal to carry out a multi-institutional randomized controlled trial (RCT) of internet-delivered behavioral intervention in a large population of youth with SCD. The long-term goal of this research is to develop effective, easily accessible, behavioral pain interventions for youth with SCD to reduce the long-term impact of pain on function, quality of life, and health service use in this population.
The design of this study is an experimental 2 (group) x 3 (time of measurement) randomized controlled trial design to test the acceptability and efficacy of the Web-MAP intervention in reducing pain and functional impairment in youth with sickle cell disease. (Figure 1) Subjects will be randomized to either the behavioral intervention or the online patient education control group. The treatment protocol will be implemented over 8 weeks in Internet-based treatment modules. The primary study outcome is pain and functional impairment measured at baseline, immediately post-treatment, and at 3-month follow-up.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
The proposed study will determine whether the efficacy of WebMAP generalizes to pediatric SCD, and explore whether the intervention is feasible and acceptable to this population. Feasibility of multi-institutional recruitment from sickle cell centers will also be determined. The short-term goal is to produce preliminary data to apply for an R01 proposal to carry out a multi-institutional randomized controlled trial (RCT) of internet-delivered behavioral intervention in a large population of youth with SCD. The long-term goal of this research is to develop effective, easily accessible, behavioral pain interventions for youth with SCD to reduce the long-term impact of pain on function, quality of life, and health service use in this population.
The design of this study is an experimental 2 (group) x 3 (time of measurement) randomized controlled trial design to test the acceptability and efficacy of the Web-MAP intervention in reducing pain and functional impairment in youth with sickle cell disease. (Figure 1) Subjects will be randomized to either the behavioral intervention or the online patient education control group. The treatment protocol will be implemented over 8 weeks in Internet-based treatment modules. The primary study outcome is pain and functional impairment measured at baseline, immediately post-treatment, and at 3-month follow-up.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Connecticut
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Hartford, Connecticut, Estados Unidos, 06106
- CCMC
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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:
- Documented sickle cell disease (verified by physician at SCD center if referred participant is a self referral)
- 11-18 years old
- Parental/patient consent and patient assent
- Internet and computer or smartphone access
- Score of >3 on the SCPBI-Y
Exclusion Criteria:
- Primary language spoken other than English
- 11<Age≤19
- Serious comorbid chronic condition (e.g., diabetes, arthritis, cancer)
- More than 4 sessions of outpatient behavioral therapy for pain management in the 6 months prior to the time of screening
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: WEB-MAP CBT
Web-MAP Group.
Participants will have access to the full version of the web program.
They will be asked to log in to the website using their own personal computer at home, work, school, or a public library.
Participants in the Web-MAP group will have access to treatment modules and daily diaries on the web site.
The online treatment will take between 8 and 9 weeks for participants to complete.
Children and parents will be asked to log onto the web site, read through the treatment modules, and complete practice assignments to learn new skills (e.g., relaxation).
Adolescents and parents will be asked to complete a total of 8 modules each.
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Web-MAP Group: Participants will have access to the full version of the web program.
They will be asked to log in to the website using their own personal computer at home, work, school, or a public library.
Participants in the Web-MAP group will have access to treatment modules and daily diaries on the web site.
The online treatment will take between 8 and 9 weeks for participants to complete.
Children and parents will be asked to log onto the web site, read through the treatment modules, and complete practice assignments to learn new skills (e.g., relaxation).
Adolescents and parents will be asked to complete a total of 8 modules each.
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Comparador activo: WEB-MAP Educational Control Group
OPEC (Online Patient Education Control) Group: The purpose of the patient education control group is to control for time, attention, and computer usage.
This group will serve as an attention control condition.
Children will continue with the standard medical care that has been prescribed for their pain problem.
Children and parents will be provided with access to a revised version of the Web-MAP study website, which will have two functional components: 1) information from publicly available educational websites about pediatric chronic pain management, 2) diary and assessments.
This version of the website differs from the one accessed by the treatment condition in that it does not provide access to behavioral and cognitive skills training via treatment modules for children and parents.
|
OPEC (Online Patient Education Control) Group: The purpose of the patient education control group is to control for time, attention, and computer usage.
This group will serve as an attention control condition.
Children will continue with the standard medical care that has been prescribed for their pain problem.
Children and parents will be provided with access to a revised version of the Web-MAP study website, which will have two functional components: 1) information from publicly available educational websites about pediatric chronic pain management, 2) diary and assessments.
This version of the website differs from the one accessed by the treatment condition in that it does not provide access to behavioral and cognitive skills training via treatment modules for children and parents.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Efficacy in pain reduction
Periodo de tiempo: 6 months
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We will compare pain intensity (pain scores), pain burden (Sickle Cell Pain Burden Interview), activity limitations (Child Activity Limitations Interview), quality of life (PedsQL), and health service use, and their corresponding changes from baseline to T2 (immediately after finishing the treatment arm) and T3 (6 months after enrollment in study).
We will used a paired sample t-test.
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6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Efficacy of reducing depressive symptoms
Periodo de tiempo: 6 months
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We will compare changes changes in depressive symptoms using the Centers for Epidemiological Study Depression scale from baseline to T2 (immediately after finishing the treatment arm) and T3 (6 months after enrollment in study).
We will used a paired sample t-test.
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6 months
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Feasibility of WEB-MAP program
Periodo de tiempo: 6 months
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We will conduct interviews with participants of the study using a script to start a dialogue on how user friendly their interface is, perceived difficulties or barriers, improvements to make, and general overall feedback to modify the program.
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6 months
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: William T Zempsky, MD, MPH, Connecticut Children's Medical Center
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 13-032
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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