Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05160194
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2021-08-30
Brief Title:
Gaining Real-Life Skills Over the Web
Sponsor:
Childrens Hospital Medical Center Cincinnati
Organization:
Childrens Hospital Medical Center Cincinnati
Study Overview
Official Title:
Gaining Real-Life Skills Over the Web GROW
Status:
COMPLETED
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GROW
Brief Summary:
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
Detailed Description:
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None