A Just-in-Time Adaptive Intervention for Child and Family Mental Health
NCT ID: NCT06443918
Last Updated: 2024-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
357 participants
INTERVENTIONAL
2024-05-20
2025-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Intervention
The intervention aims to improve child and family mental health and functioning through psychoeducation and family-based activities delivered via a smartphone app. This intervention also includes a just-in-time adaptive intervention (JITAI) for coaching family interactions in real-time. Caregivers will wear smartwatches and carry smartphones for 8 weeks. Children will wear smartwatches. A variety of types of data will be collected from the phones and watches, such as heart rate, activity levels, and sleep. We will also collect daily surveys, daily audio recordings, a 15-minute survey every 2 weeks about their experiences using the app, and check-in calls every 2 weeks.
A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Families in the intervention group will download an app on their smartphones. The app will deliver psychoeducational modules and family-based homework activities. It will include a component where AI is used to assess the quality of family-based interactions and provide in-the-moment feedback and coaching to guide the family interaction.
Control group
Caregivers will wear smartwatches and carry smartphones for 8 weeks. Children will wear smartwatches. Participants will complete placebo psychoeducational modules matched in length and reading level to the intervention content. A variety of types of data will be collected from the phones and watches, such as heart rate, activity levels, and sleep. We will also collect daily surveys, daily audio recordings, a 15-minute survey every 2 weeks about their experiences using the app, and check-in calls every 2 weeks.
No interventions assigned to this group
Interventions
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A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Families in the intervention group will download an app on their smartphones. The app will deliver psychoeducational modules and family-based homework activities. It will include a component where AI is used to assess the quality of family-based interactions and provide in-the-moment feedback and coaching to guide the family interaction.
Eligibility Criteria
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Inclusion Criteria
* At least one participating family member identifies as belonging to an ethnic/racial minoritized group AND
* Child mental health symptoms at or above the 70th percentile based on any subscale of the Strengths and Difficulties Questionnaire AND
* Participants speak English and/or Spanish AND
* Have a child 6-9 years old at the time of enrollment AND
* Families must be located in Texas or Florida
Exclusion Criteria
* Active homicidal ideation OR
* Current child abuse OR
* Current violence in the home
6 Years
ALL
No
Sponsors
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National Institute of Mental Health (NIMH)
NIH
Colliga Apps Corp.
INDUSTRY
Responsible Party
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Principal Investigators
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Matthew Ahle, B.S.
Role: PRINCIPAL_INVESTIGATOR
Colliga Apps
Adela Timmons, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
The University of Texas at Austin
Jonthan Comer, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Florida International University
Locations
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Florida International University
Miami, Florida, United States
The University of Texas at Austin
Austin, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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Colliga Apps website
Other Identifiers
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