- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT07679620
Disseminating Effective Sexual Health Programs in Schools Using iCHAMPSS
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Belinda Hernandez, PhD, MPH
- Número de teléfono: (210) 276-9009
- Correo electrónico: Belinda.Hernandez@uth.tmc.edu
Copia de seguridad de contactos de estudio
- Nombre: Laura Thormaehlen
- Número de teléfono: (713) 500-9000
- Correo electrónico: Laura.C.Thormaehlen@uth.tmc.edu
Ubicaciones de estudio
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Texas
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Houston, Texas, Estados Unidos, 77030
- Reclutamiento
- The University of Texas Health Science Center at Houston
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Contacto:
- Belinda Hernandez, PhD, MPH
- Número de teléfono: (210) 276-9009
- Correo electrónico: Belinda.Hernandez@uth.tmc.edu
-
Contacto:
- Laura Thormaehlen
- Número de teléfono: (713) 500-9000
- Correo electrónico: Laura.C.Thormaehlen@uth.tmc.edu
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Licensed educator or administrator who holds one of the following positions: 1) district or school administrator (e.g., health coordinators, instructional specialists, and curriculum coordinators), 2) health and physical education teachers, and 3) social and health service staff (e.g., nurses and counselors) in a Texas school district participating in the iCHAMPSS 2.0 study
Exclusion Criteria:
- not holding a job in a Texas school district as a school stakeholder, OR holding a job in a Texas school district as a school stakeholder but not in a school district participating in the iCHAMPSS 2.0 study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Arm 1: 1 semester of implementation then 7 semesters of intervention
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iCHAMPSS 2.0 is designed for Program Champions, critical to EBP use, such as district and school administrators, SHAC members (which include parents), and health and physical education teachers, who are highly motivated to promote sexual health education. iCHAMPSS 2.0 has four features:
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Experimental: Arm 2: 1 semester of control, 1 semester of implementation then 7 semesters of intervention
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iCHAMPSS 2.0 is designed for Program Champions, critical to EBP use, such as district and school administrators, SHAC members (which include parents), and health and physical education teachers, who are highly motivated to promote sexual health education. iCHAMPSS 2.0 has four features:
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Experimental: Arm 3: 1 semesters of control, 1 semester of implementation then 6 semesters of intervention
|
iCHAMPSS 2.0 is designed for Program Champions, critical to EBP use, such as district and school administrators, SHAC members (which include parents), and health and physical education teachers, who are highly motivated to promote sexual health education. iCHAMPSS 2.0 has four features:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
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Change in percentage of schools within a district implementing an EBP
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Rate of implementation of the EBP
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of School Health Advisory Councils (SHACs) that have recommended a sexual health EBP to their school board
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Percentage of School Health Advisory Councils (SHACs) that have adopted a sexual health EBP to their school board
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Percentage of schools with the school board's approval of an Evidence Based Program (EBP)
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Percentage of schools with the principal's approval of an EBP
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Percentage of students receiving majority (over 50%) of a sexual health EBP
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Percentage of schools that have implemented the evidence-based program for more than one academic year as assessed by the implementation survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in perceived complexity as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
This is a 3 item questionnaire and each is scored form (1) Strongly disagree to (5) Strongly agree, maximum score of 15, higher score indicating worse outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in compatibility as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 5 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree maximum score 25, higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in relative advantage as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 4 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree, maximum score of 20, higher score indicating better better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in perceived social systems support in parent community as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 8 item questionnaire and each is scored from (1) not at all supportive to (4) very supportive , maximum score of 32 , higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in presence of school policy as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 2 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 10, higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in adequate resources as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 5 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score of 25, higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in presence of a program champion as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 4 item questionnaire and each is scored 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in implementation climate as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 6 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score of 30, higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
|
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Change in inter organizational relationships as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 4 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
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Change in intra organizational relationships as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 4 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in perceived need as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 4 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree, maximum score range of 20, higher score indicating worse outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
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Change in self-efficacy as assessed by the staff survey
Periodo de tiempo: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 19 item questionnaire and each is scored from 1(not at all confident)-4(very confident) , maximum score range of 76, higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Frequency of use of iCHAMPSS 2.0 as assessed by the website analytics
Periodo de tiempo: From baseline to end of school year (about 7 to 12 months from baseline)
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From baseline to end of school year (about 7 to 12 months from baseline)
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Time spent using iCHAMPSS 2.0 as assessed by the district coordinator survey
Periodo de tiempo: From baseline to end of school year (about 7 to 12 months from baseline)
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This will be reported categorically as less than one hour, 1-2 hours, 3-4 hours, 5-6 hours and 7 hours or more
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From baseline to end of school year (about 7 to 12 months from baseline)
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Number of recurring users of iCHAMPSS 2.0 as assessed by the website analytics
Periodo de tiempo: From baseline to end of school year (about 7 to 12 months from baseline)
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From baseline to end of school year (about 7 to 12 months from baseline)
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Number of unique users of iCHAMPSS 2.0 as assessed by the website analytics
Periodo de tiempo: From baseline to end of school year (about 7 to 12 months from baseline)
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From baseline to end of school year (about 7 to 12 months from baseline)
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Mean number of users per school district of iCHAMPSS 2.0 as assessed by the website analytics
Periodo de tiempo: From baseline to end of school year (about 7 to 12 months from baseline)
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From baseline to end of school year (about 7 to 12 months from baseline)
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Percentage of school districts/schools using iCHAMPSS 2.0 as assessed by the website analytics
Periodo de tiempo: From baseline to end of school year (about 7 to 12 months from baseline)
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From baseline to end of school year (about 7 to 12 months from baseline)
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Percentage of iCHAMPSS 2.0 tools used in each step as assessed by the website analytics
Periodo de tiempo: From baseline to end of school year (about 7 to 12 months from baseline)
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From baseline to end of school year (about 7 to 12 months from baseline)
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Perceived barriers to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
Periodo de tiempo: From baseline to end of school year (about 7 to 12 months from baseline)
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This will be reported as a percentage
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From baseline to end of school year (about 7 to 12 months from baseline)
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Perceived facilitators to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
Periodo de tiempo: From baseline to end of school year (about 7 to 12 months from baseline)
|
This will be reported as a percentage
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From baseline to end of school year (about 7 to 12 months from baseline)
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Colaboradores e Investigadores
Colaboradores
Investigadores
- Investigador principal: Belinda Hernandez, PhD, MPH, The University of Texas Health Science Center, Houston
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
Otros números de identificación del estudio
- HSC-SPH-24-0672
- R01HD111699 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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.
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. .