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

Colliga Apps Corp.

Status: Enrolling

Conditions: Family Functioning; Mental Health and Well-being

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

Study type: Interventional

Funder types: Industry; NIH

Identifiers

NCT06443918

R44MH123368 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 357 estimated patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• A family income less than or equal to the 33rd percentile for their county of residence OR
• 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 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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357 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

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

Control group

No Intervention group

Description:

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.