Ignite Creation Date:
2024-05-06 @ 6:54 PM
Last Modification Date:
2024-10-26 @ 2:56 PM
Study NCT ID:
NCT05822687
Status:
RECRUITING
Last Update Posted:
2023-04-21
First Post:
2023-02-17
Brief Title:
Factorial Optimization Trial to Test Effects of Coping Intervention Components
Sponsor:
Arizona State University
Organization:
Arizona State University
Study Overview
Official Title:
Promoting Effective Coping by Children Exposed to Post-divorce Interparental Conflict to Reduce Risk for Mental Health Problems
Status:
RECRUITING
Status Verified Date:
2024-07
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:
This study will identify components for inclusion in a coping intervention package to reduce mental health problems among children exposed to high interparental conflict after parental separationdivorce Reappraisal distraction and relaxation coping strategies are related to fewer mental health problems among children making intervention components based on these strategies key candidates for inclusion in an optimized coping intervention The primary aim is to experimentally assess the main and interactive effects of three digital intervention coping components reappraisal distraction relaxation on childrens coping efficacy emotional security and internalizing and externalizing problems Secondary aims are to assess indirect effects of the intervention components on childrens coping efficacy emotional security and internalizing and externalizing problems through their cognitive emotional and behavioral reactions to post-separationdivorce interparental conflict events
Detailed Description:
A randomized and counterbalanced 2x2x2 factorial trial N 144 children ages 9-12 will be conducted to assess the individual effects of the three digital coping intervention components The three components to be tested will be 1 Reappraisal No vs Yes 2 Distraction No vs Yes 3 Relaxation No vs Yes Components that meet a priori thresholds for meaningful change will be combined to form an intervention package that will be evaluated in a subsequent randomized controlled trial
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| K01MH120321 | NIH | None | httpsreporternihgovquickSearchK01MH120321 |