Gaining Real-Life Skills Over the Web (GROW)
7 de marzo de 2022 actualizado por: Children's Hospital Medical Center, Cincinnati
Gaining Real-Life Skills Over the Web (GROW)
Gaining Real-life Skills Over the Web (GROW) is an online parenting-skills intervention for caregivers of children aged 0-4 who sustained traumatic brain injuries.
GROW is designed to promote family and child coping and adjustment for caregivers.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This project develops and evaluates an online learning environment of web-based intervention modules designed to promote family and child coping and adjustment (GROW: Gaining Real-life Skills Over the Web) based on a comprehensive needs assessment of children aged 0 to 14 years old, who experienced a traumatic brain injury (TBI) between the ages of 0 to 4 years, and their families.
The incidence of TBI peaks between the ages 0 to 4 years, yet there are no evidenced-based interventions to facilitate neurocognitive development and socio-emotional functioning of children injured during this critical development period.
To address the unmet need of caregivers of infants and toddlers with TBI, the project uses a three-phase development process to generate proof of concept and initial proof of product.
Phase 1 involves a comprehensive needs assessment that includes quantitative assessment of family and child needs, qualitative assessment through focus groups and interviews of families, feedback from family and professional advisory boards, and consultation with professionals implementing interventions with similar populations (e.g., families of children with very low birth weight).
During Phase 2, the project develops the content and manual for the intervention modules, designs the online learning environment, and conducts intensive, iterative usability testing.
Phase 3 involves a pilot of the GROW program with 20 families to evaluate its usability, acceptability, and qualitative and quantitative impact on stakeholder identified outcomes.
Tipo de estudio
Intervencionista
Inscripción (Actual)
18
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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Ohio
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Cincinnati, Ohio, Estados Unidos, 45229
- Cincinnati Children's Hospital Medical 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
1 segundo a 4 años (Niño)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Age at injury and enrollment: ages 0-4, inclusive
- Overnight hospitalization for traumatic brain injury
- Mechanism of injury: Non-penetrating traumatic brain injury; abusive head trauma (AHT) will be included
- Language: English must be the primary spoken language in the home
Exclusion Criteria:
- Does not reside with the caregiver at least half-time
- The caregiving situation is not stable (i.e., there must be no scheduled custody hearings)
- English is not the primary language spoken in the home
- Families of children who are non-responsive or in a persistent vegetative state will also be excluded
- Caregivers with a psychiatric hospitalization in the past year will be ineligible to participate
- If AHT is the suspected injury mechanism, the child must not reside with the suspected abuser, must have been in the current living situation for at least 6 months, and must be anticipated to remain in this living situation for the next 6 months. The study team will only recruit non-abusing caregivers (including foster parents) to participate.
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: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Otro: GROW Intervention
Every participant received the GROW Intervention, chose not to participate in the GROW intervention, or dropped out before completing the GROW Intervention.
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The highly interactive GROW Program consists of 5 core modules and 1 optional, supplemental session.
Each session is expected to take 15-20 minutes to complete, and at the end of each module, parents record a 5 minute "special play time" video interacting with their child to demonstrate the skills they learned in the session.
Each online module is followed by a meeting with a trained therapist who will discuss their "special play time" video and the skills they are learning.
Parents make their way through the 5 core modules sequentially before accessing the supplemental session that may be relevant to them.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Center for Epidemiologic Studies Depression(CES-D) Scale Change
Periodo de tiempo: Pre-Intervention and Immediately Post-Intervention
|
Measuring caregiver psychological distress, the CES-D consists of 20 items that are rated on a 4-point likert scale (from 1: rarely or none of the time to 4: most or all of the time).
Scores range from zero to sixty.
Higher scores indicated a higher frequency of depressive symptoms during the last week.
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Pre-Intervention and Immediately Post-Intervention
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Parenting Stress Index (PSI) Change
Periodo de tiempo: Pre-Intervention and Immediately Post-Intervention
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The study team used the 36 item short form PSI to measure caregiver stress.
Using a 4-point likert scale, the stress scores range from 18 to 90, with lower scores indicating lower levels of parental stress.
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Pre-Intervention and Immediately Post-Intervention
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Patient-Reported Outcomes Measurement Information System Change
Periodo de tiempo: Pre-Intervention and Immediately Post-Intervention
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The study team used only the Sleep, Stress, and Anxiety Measures which are rated on a 5-point likert scale.
Each measure has a range in score from 7 to 35 with higher scores indicating greater severity.
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Pre-Intervention and Immediately Post-Intervention
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Family Burden of Injury Interview (FBII) Change
Periodo de tiempo: Pre-Intervention and Immediately Post-Intervention
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The FBII measures family burden.
Open-ended answers are coded Yes/No and are given a stress rating of 0 (not at all)-5(extremely stressful).
Caregiver responses are averaged to provide an index of injury-related family burden.
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Pre-Intervention and Immediately Post-Intervention
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MacArthur-Bates Communicative Development Inventories (MB-CDI) Change
Periodo de tiempo: Pre-Intervention and Immediately Post-Intervention
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Using the short form MB-CDIs to measure child language abilities, the scoring scale is a minimum of 0- maximum of 310 with greater scores showing better language abilities.
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Pre-Intervention and Immediately Post-Intervention
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Caregiver-Child Observation Change
Periodo de tiempo: Pre-Intervention and Immediately Post-Intervention
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Using the Parent/Child Toy Play Ratings in the Play and Learning Strategies (PALS) manual, 6 domains (warmth, contingent responsiveness, demonstration/physical teaching, verbal stimulation/scaffolds, restrictions, and negativity/intrusiveness) are rated on scales of 1 to 5 with 1 being the worst rating and 5 being the best.
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Pre-Intervention and Immediately Post-Intervention
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GROW Satisfaction Survey
Periodo de tiempo: Immediately Post-Intervention
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Satisfaction with intervention measured in both 5-point likert scale ratings (with higher values showing greater satisfaction) and open-ended feedback about participant experience in the program.
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Immediately Post-Intervention
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Background & Family Information Form
Periodo de tiempo: Pre-Intervention
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Demographics rehabilitation services
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Pre-Intervention
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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 (Actual)
30 de septiembre de 2017
Finalización primaria (Actual)
30 de septiembre de 2021
Finalización del estudio (Actual)
30 de septiembre de 2021
Fechas de registro del estudio
Enviado por primera vez
30 de agosto de 2021
Primero enviado que cumplió con los criterios de control de calidad
3 de diciembre de 2021
Publicado por primera vez (Actual)
16 de diciembre de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
21 de marzo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
7 de marzo de 2022
Última verificación
1 de septiembre de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 90IFDV0003
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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