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

Family Functioning Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06443918
• Other study ID #: R44MH123368
• Secondary ID: R44MH123368
• Status: Recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: May 2024
• Source: Colliga Apps Corp.
• Contact: Matthew Ahle, B.S.
• Phone: 512-514-6037
• Email: mahle[@]colligaapps.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 357
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Family Functioning

Intervention

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.

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas
United States	Florida International University	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Colliga Apps Corp.	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Child physical health measured via the Child Health Questionnaire	Children in the intervention group will evidence decreased physical health symptoms compared to children in the control group.	8 weeks
Other	Caregiver physical health measured via the Patient Health Questionnaire	Caregivers in the intervention group will evidence decreased physical health symptoms compared to parents in the control group.	8 weeks
Primary	Child mental health symptoms measured by the Child Behavior Checklist	Children in the intervention group will evidence decreased mental health symptoms compared to children in the control group.	8 weeks
Primary	Child attachment measured via the Attachment Style Classification Questionnaire for Latency Age Children	Children in the intervention group will evidence increased secure attachment compared to children in the control group.	8 weeks
Primary	Parent-child conflict measured via the Parent-Child Conflict Tactics Scale	Children in the intervention group will evidence decreased parent-child conflict compared to children in the control group.	8 weeks
Secondary	Caregiver mental health measured via the Symptoms Checklist 27-Plus	Caregivers in the intervention group will evidence decreased mental health symptoms compared to caregivers in the control group.	8 weeks
Secondary	Caregiver attachment measured via the Experiences in Close Relationships Scale	Caregivers in the intervention group will evidence increased secure attachment compared to caregivers in the control group.	8 weeks
Secondary	Inter-parental conflict measured via the Conflict Tactics Scale	Caregivers in the intervention group will evidence decreased inter-parental conflict compared to caregivers in the control group.	8 weeks

External Links

•   Colliga Apps website