An app-based intervention to improve child and family mental health
A Just-in-Time Adaptive Intervention for Child and Family Mental Health
NA · Colliga Apps Corp. · NCT06443918
This study is testing an app designed to help improve the mental health of children aged 6-9 and their families by providing real-time support and activities.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 357 (estimated) |
| Ages | 6 Years and up |
| Sex | All |
| Sponsor | Colliga Apps Corp. (industry) |
| Locations | 2 sites (Miami, Florida and 1 other locations) |
| Trial ID | NCT06443918 on ClinicalTrials.gov |
What this trial studies
This clinical trial tests an app-based just-in-time adaptive intervention (JITAI) aimed at enhancing mental health and family functioning for children aged 6-9. Participants will engage with the app to receive real-time feedback and complete psychoeducational activities designed to support their mental well-being. The study will compare outcomes between families using the app and those in a control group over an 8-week period, assessing various aspects of mental health and family dynamics through surveys and data collection. Caregivers and children may use their own devices or be provided with smartphones and wearables for the duration of the study.
Who should consider this trial
Good fit: Ideal candidates include families with a child aged 6-9 who have mental health symptoms and meet specific socioeconomic or ethnic/racial criteria.
Not a fit: Patients with active suicidal or homicidal ideation, current child abuse, or violence in the home may not benefit from this intervention.
Why it matters
Potential benefit: If successful, this intervention could significantly improve mental health outcomes for children and their families.
How similar studies have performed: Other studies have shown promise with digital mental health interventions, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Miami, Florida and 1 other locations
- Florida International University — Miami, Florida, United States (NOT_YET_RECRUITING)
- The University of Texas at Austin — Austin, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Matthew Ahle, B.S. — Colliga Apps
- Study coordinator: Matthew Ahle, B.S.
- Email: mahle@colligaapps.com
- Phone: 512-514-6037
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mental Health and Well-being, Family Functioning, Mental health and well-being, Child development, Digital mental health, Digital intervention, Family functioning