Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443918
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-02-23
Brief Title:
A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Sponsor:
Colliga Apps Corp
Organization:
Colliga Apps Corp
Study Overview
Official Title:
A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Status:
RECRUITING
Status Verified Date:
2024-05
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:
The goal of this clinical trial is to test an app-based just-in-time-adaptive intervention JITAI The intervention aims to improve child and family mental health A JITAI provides in-the-moment feedback to coach families The questions it tests are if the app will improve mental health and family functioning Participants will download an app on their phone and complete JITAI sessions Researchers will compare intervention and control groups to see if the app improves mental health
Detailed Description:
The following study tests the efficacy of an app-based program designed to improve child and family mental health and well-being The intervention will include family-based activities for improving child and family mental health and functioning delivered as psychoeducation and activities through the smartphone app as well as a just-in-time adaptive intervention JITAI component where AI analysis for family interactions will be used to provide real-time dynamic feedback to families Participants will be informed during consent that they will have a 50-50 chance of receiving the intervention The study will assess caregiver and child functioning in a variety of domains such as mental health symptoms attachment style and family conflict through a series of baseline and follow-up questionnaires Caregivers may use their own smartphones or they will be lent smartphones for the study Caregivers and children will also be lent FitbitsApple Watches The intervention will last 8 weeks Data will include daily surveys daily audio recordings 15-minute surveys every 2 weeks about their experiences using the app bi-weekly check-ins psychoeducational modules homework activities JITAI sessions and passively sensed data The intervention will be administered through the smartphone app and will include daily 5-15-minute psychoeducation modules and practice sessions and daily JITAI sessions
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 |
|---|---|---|---|
| R44MH123368 | NIH | None | httpsreporternihgovquickSearchR44MH123368 |