Family Functioning, Mental Health and Well-being
Conditions
Keywords
Mental health and well-being, Child development, Digital mental health, Digital intervention, Family functioning
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.
Interventions
BEHAVIORALA 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.
Sponsors
Colliga Apps Corp.
National Institute of Mental Health (NIMH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants will be informed during consent that they will have a 50-50 chance of receiving the intervention.
Intervention model description
Half of families will be randomly assigned to the intervention group. 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. The intervention also includes real-time feedback and coaching of family interactions through a just-in-time adaptive intervention (JITAI).
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in child internalizing symptoms, measured by the Child Behavior Checklist (CBCL) Internalizing Problems scale | 8 weeks | Assesses caregiver-reported child internalizing symptoms (e.g., anxiety, depression, withdrawal) using the Child Behavior Checklist (CBCL) Internalizing Problems scale, evaluated as change from baseline to post-intervention follow-up to determine intervention effects on child emotional functioning. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Child externalizing symptoms, measured by the Child Behavior Checklist (CBCL) Externalizing Problems scale | 8 weeks | Assesses caregiver-reported child externalizing behaviors (e.g., aggression, rule-breaking) using the Child Behavior Checklist (CBCL) Externalizing Problems scale to characterize broader child functioning and potential spillover effects of the intervention. |
| Caregiver mental health symptoms, measured by the 27-Plus (SCL-27-Plus) total score | 8 weeks | Evaluates caregiver psychological distress across multiple symptom domains using the Symptom Checklist-27-Plus (SCL-27-Plus) total score to examine changes in caregiver mental health associated with participation. |
| Child attachment | 8 weeks | Assesses the quality of the child's attachment-related behaviors and relational security within the caregiver-child relationship using the Attachment Style Questionnaire for Latency Age Children to evaluate changes in child attachment functioning |
| Caregiver attachment | 8 weeks | Measures the frequency and severity of aggressive or harsh behaviors occurring within the parent-child relationship using the Conflict Tactics Scale Parent-Child version. |
| Parent-child aggression | 8 weeks | Measures the frequency and severity of aggressive or harsh behaviors occurring within the parent-child relationship using the Conflict Tactics Scale Parent-Child version. |
| Inter-parental aggression | 8 weeks | Assesses the occurrence and intensity of conflict and aggressive behaviors between caregivers using the Conflict Tactics Scale (Partner Version; CTS2) partner-report form to characterize changes in inter-parental conflict. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMatthew Ahle, B.S.
Colliga Apps
PRINCIPAL_INVESTIGATORAdela Timmons, Ph.D.
The University of Texas at Austin
PRINCIPAL_INVESTIGATORJonthan Comer, Ph.D.
Florida International University
Outcome results
None listed