NCT06443918

A Just-in-Time Adaptive Intervention for Child and Family Mental Health

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 347 (actual)
• Sponsor: Colliga Apps Corp. · Industry
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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 Fitbits/Apple 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.

Conditions

• Mental Health and Well-being
• Family Functioning

Interventions

Type	Name	Description
BEHAVIORAL	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.

Timeline

• Start date: 2024-05-20
• Primary completion: 2026-01-14
• Completion: 2026-01-14
• First posted: 2024-06-05
• Last updated: 2026-03-10

Locations

2 sites across 1 country: United States