Ignite Creation Date:
2025-12-24 @ 10:33 PM
Ignite Modification Date:
2025-12-25 @ 8:05 PM
Study NCT ID:
NCT05722535
Status:
RECRUITING
Last Update Posted:
2025-05-15
First Post:
2023-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Shared Decision Making to Improve Family Media Use Planning
Sponsor:
Seattle Children's Hospital
Organization:
Study Overview
Official Title:
Using Shared Decision Making to Improve Family Media Use Planning
Status:
RECRUITING
Status Verified Date:
2025-05
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:
None
Brief Summary:
Investigators will conduct a pilot randomized controlled trial assessing the efficacy and feasibility of the newly developed Family Media Check-In (FMC).
Detailed Description:
The clinical trial portion of this study will enroll 150 families (child age 11-17, and at least one parent/guardian). Stratified randomization will be used to assign families to the intervention (FMC) or control (delayed FMC) condition. Families assigned to the intervention condition will be asked to complete the FMC within 2 weeks of randomization and will be sent a second survey one week after completion. Participants in the control condition will complete a condition-specific subset of these questions three weeks after baseline. Participants in both conditions will complete a follow-up survey two months after their second survey.
The primary outcomes will be measured at the first follow-up period and will be related to screen media planning and decision making. Two-month follow-up surveys will explore intervention impact on screen media practices.
Prior to the clinical trial portion of the study, the study team conducted interviews/focus groups, participatory design sessions, and usability testing sessions with a diverse group of families to refine the concept for the intervention and to iteratively develop the intervention itself. Changes in the behavioral targets and components of the intervention and outcomes for the evaluation (relative to the original grant proposal) were driven by family-expressed needs and priorities.
The primary outcomes will be measured at the first follow-up period and will be related to screen media planning and decision making. Two-month follow-up surveys will explore intervention impact on screen media practices.
Prior to the clinical trial portion of the study, the study team conducted interviews/focus groups, participatory design sessions, and usability testing sessions with a diverse group of families to refine the concept for the intervention and to iteratively develop the intervention itself. Changes in the behavioral targets and components of the intervention and outcomes for the evaluation (relative to the original grant proposal) were driven by family-expressed needs and priorities.
Study Oversight
Has Oversight DMC:
False
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?: