A Just-in-Time Adaptive Intervention for Child and Family Mental Health
- Conditions
- Mental Health and Well-beingFamily Functioning
- Interventions
- Behavioral: A Just-in-Time Adaptive Intervention for Child and Family Mental Health
- Registration Number
- NCT06443918
- Lead Sponsor
- Colliga Apps Corp.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 357
Not provided
- Active suicidal ideation OR
- Active homicidal ideation OR
- Current child abuse OR
- Current violence in the home
Families meeting these exclusion criteria will undergo a clinical risk assessment and be referred for alternative treatment services.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention A Just-in-Time Adaptive Intervention for Child and Family Mental Health 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.
- Primary Outcome Measures
Name Time Method Child mental health symptoms measured by the Child Behavior Checklist 8 weeks Children in the intervention group will evidence decreased mental health symptoms compared to children in the control group.
Child attachment measured via the Attachment Style Classification Questionnaire for Latency Age Children 8 weeks Children in the intervention group will evidence increased secure attachment compared to children in the control group.
Parent-child conflict measured via the Parent-Child Conflict Tactics Scale 8 weeks Children in the intervention group will evidence decreased parent-child conflict compared to children in the control group.
- Secondary Outcome Measures
Name Time Method Caregiver mental health measured via the Symptoms Checklist 27-Plus 8 weeks Caregivers in the intervention group will evidence decreased mental health symptoms compared to caregivers in the control group.
Caregiver attachment measured via the Experiences in Close Relationships Scale 8 weeks Caregivers in the intervention group will evidence increased secure attachment compared to caregivers in the control group.
Inter-parental conflict measured via the Conflict Tactics Scale 8 weeks Caregivers in the intervention group will evidence decreased inter-parental conflict compared to caregivers in the control group.
Trial Locations
- Locations (2)
Florida International University
🇺🇸Miami, Florida, United States
The University of Texas at Austin
🇺🇸Austin, Texas, United States