- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01822392
On-line Treatment for Conduct Problems
4 de febrero de 2015 actualizado por: Alan E. Kazdin, Yale University
The research evaluates the use of online versions of delivering an effective psychological treatment for children clinically referred for serious oppositional, aggressive, and antisocial behavior.
The goal is to develop models of delivery that reach families in need that are not being served by in-person treatment.
The project has immediate implications for the treatment of children but more generally addresses several issues critical to treatments that are based on Internet, telepsychiatry, and related technologies.
Descripción general del estudio
Estado
Terminado
Tipo de estudio
Intervencionista
Inscripción (Actual)
86
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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Connecticut
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New Haven, Connecticut, Estados Unidos, 06511
- Yale Parenting Center
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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 12 años (Niño)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Diagnosis of Conduct Disorder of Oppositional Defiant Disorder (for the child)
- Residence in the state of CT
- Access to a computer and high-speed Internet access
- English fluency (at least one parent)
- No history of significant developmental delay (for the child)
- Parental consent
Exclusion Criteria:
- Participation in another form of psychotherapy or counseling that is directed toward the reduction of social, emotional, or behavioral problems
- Evidence of recent suicidality (for the child)
- Current or lifetime diagnosis of a Pervasive Developmental Disorder
- Primary diagnoses of a mood or anxiety disorder
- Acute family crisis
- Parent or guardian who can participate in treatment shows current psychosis or an uncontrolled medical condition
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: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Comparador activo: Online treatment, High therapist contact
Participants receive online Parent Management Training (interactive).
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Experimental: Online treatment, Low therapist contact
Participants receive online Parent Management Training (recorded).
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Child Behavior Checklist
Periodo de tiempo: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Internalizing and externalizing behavior problems in children
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Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Child Global Assessment Scale
Periodo de tiempo: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
|
Therapist-rated measure of overall child impairment and functioning
|
Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Interview for Antisocial Behavior
Periodo de tiempo: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Presence of a broad range of overt and covert antisocial behaviors in children
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Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Research Diagnostic Interview
Periodo de tiempo: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Clinical symptoms and diagnoses based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria
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Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Parenting Stress Index
Periodo de tiempo: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Sources of stress for the parent
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Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Beck Depression Inventory
Periodo de tiempo: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Parental symptoms of depression
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Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Management of Child Behavior Scale
Periodo de tiempo: Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Parenting practices
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Change from pretreatment (Week 0; immediately before the start of treatment) to posttreatment (immediately after treatment is completed; Week 8)
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Parent-Therapist Relationship Scale (Therapist version)
Periodo de tiempo: Midtreatment (Week 4 of treatment)
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Characteristics of the therapeutic relationship according to therapist report
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Midtreatment (Week 4 of treatment)
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Parent-Therapist Relationship Scale (Therapist version)
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Characteristics of the therapeutic relationship according to therapist report
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Posttreatment (immediately after treatment is completed; Week 8)
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Parent-Therapist Relationship Scale (Parent version)
Periodo de tiempo: Midtreatment (Week 4 of treatment)
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Characteristics of the therapeutic relationship according to parent report
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Midtreatment (Week 4 of treatment)
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Parent-Therapist Relationship Scale (Parent version)
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Characteristics of the therapeutic relationship according to parent report
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Posttreatment (immediately after treatment is completed; Week 8)
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Barriers to Participation in Treatment (Therapist version)
Periodo de tiempo: Midtreatment (Week 4 of treatment)
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Stressors and obstacles that interfere with treatment
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Midtreatment (Week 4 of treatment)
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Barriers to Participation in Treatment (Therapist version)
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Stressors and obstacles that interfere with treatment
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Posttreatment (immediately after treatment is completed; Week 8)
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Barriers to Participation in Treatment (Parent version)
Periodo de tiempo: Midtreatment (Week 4 of treatment)
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Stressors and obstacles that interfere with treatment
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Midtreatment (Week 4 of treatment)
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Barriers to Participation in Treatment (Parent version)
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Stressors and obstacles that interfere with treatment
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Posttreatment (immediately after treatment is completed; Week 8)
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Weekly Participation in Treatment
Periodo de tiempo: Weekly (during treatment)
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Attendance and participation in treatment sessions
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Weekly (during treatment)
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Treatment Adherence Inventory (Therapist version)
Periodo de tiempo: Midtreatment (Week 4 of treatment)
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Parental compliance with specific treatment techniques
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Midtreatment (Week 4 of treatment)
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Treatment Adherence Inventory (Therapist version)
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Parental compliance with specific treatment techniques
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Posttreatment (immediately after treatment is completed; Week 8)
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Treatment Adherence Inventory (Parent version)
Periodo de tiempo: Midtreatment (Week 4 of treatment)
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Parental compliance with specific treatment techniques
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Midtreatment (Week 4 of treatment)
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Treatment Adherence Inventory (Parent version)
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Parental compliance with specific treatment techniques
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Posttreatment (immediately after treatment is completed; Week 8)
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Therapist Evaluation Inventory
Periodo de tiempo: Midtreatment (Week 4 of treatment)
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Acceptability of treatment based on therapist report
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Midtreatment (Week 4 of treatment)
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Therapist Evaluation Inventory
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Acceptability of treatment based on therapist report
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Posttreatment (immediately after treatment is completed; Week 8)
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Parent Evaluation Inventory
Periodo de tiempo: Midtreatment (Week 4 of treatment)
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Acceptability of treatment based on parent report
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Midtreatment (Week 4 of treatment)
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Parent Evaluation Inventory
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Acceptability of treatment based on parent report
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Posttreatment (immediately after treatment is completed; Week 8)
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Acceptability of Treatment Modality
Periodo de tiempo: Midtreatment (Week 4 of treatment)
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Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically
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Midtreatment (Week 4 of treatment)
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Acceptability of Treatment Modality
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Parent-report measure rating the acceptability of online treatment and barriers that may affect participants receiving online treatment specifically
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Posttreatment (immediately after treatment is completed; Week 8)
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Perspectives on Treatment Interview
Periodo de tiempo: Posttreatment (immediately after treatment is completed; Week 8)
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Open-ended interview questions about parents' experiences in treatment and their impressions of different aspects of online treatment delivery
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Posttreatment (immediately after treatment is completed; Week 8)
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Alan E. Kazdin, Ph.D., Yale University
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 noviembre de 2012
Finalización primaria (Actual)
1 de diciembre de 2014
Finalización del estudio (Actual)
1 de diciembre de 2014
Fechas de registro del estudio
Enviado por primera vez
22 de marzo de 2013
Primero enviado que cumplió con los criterios de control de calidad
27 de marzo de 2013
Publicado por primera vez (Estimar)
2 de abril de 2013
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
6 de febrero de 2015
Última actualización enviada que cumplió con los criterios de control de calidad
4 de febrero de 2015
Última verificación
1 de febrero de 2015
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 1108008914
- 1R34MH093326-01A1 (Subvención/contrato del NIH de EE. UU.)
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. .
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