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

Last updated: March 6, 2026
Sponsor: Colliga Apps Corp.
Overall Status: Completed

Phase

N/A

Condition

N/A

Treatment

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

Clinical Study ID

NCT06443918
R44MH123368
R44MH123368
  • Ages > 6
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion criteria:

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

  • At least one participating family member identifies as belonging to an ethnic/racialminoritized group AND

  • Child mental health symptoms at or above the 70th percentile based on any subscaleof 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

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.

Study Design

Total Participants: 347
Treatment Group(s): 1
Primary Treatment: A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Phase:
Study Start date:
May 20, 2024
Estimated Completion Date:
January 14, 2026

Study 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.

Connect with a study center

  • Florida International University

    Miami, Florida 33199
    United States

    Site Not Available

  • The University of Texas at Austin

    Austin, Texas 78712
    United States

    Site Not Available

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