Clinical trial NCT06443918: A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Official title: A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mental Health and Well-being
Family Functioning
Keywords: Mental health and well-being
Child development
Digital mental health
Digital intervention
Family functioning
Lead sponsor: Colliga Apps Corp.
Sponsor class: INDUSTRY
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-06-05
Enrollment: 357
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Child mental health symptoms measured by the Child Behavior Checklist
timeFrame: 8 weeks
measure: Child attachment measured via the Attachment Style Classification Questionnaire for Latency Age Children
timeFrame: 8 weeks
measure: Parent-child conflict measured via the Parent-Child Conflict Tactics Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Caregiver mental health measured via the Symptoms Checklist 27-Plus
timeFrame: 8 weeks
measure: Caregiver attachment measured via the Experiences in Close Relationships Scale
timeFrame: 8 weeks
measure: Inter-parental conflict measured via the Conflict Tactics Scale
timeFrame: 8 weeks
Other outcomes:
measure: Child physical health measured via the Child Health Questionnaire
timeFrame: 8 weeks
measure: Caregiver physical health measured via the Patient Health Questionnaire
timeFrame: 8 weeks
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
city: Austin
country: United States
facility: The University of Texas at Austin
state: Texas
Study officials:
affiliation: Colliga Apps
name: Matthew Ahle, B.S.
role: PRINCIPAL_INVESTIGATOR
affiliation: The University of Texas at Austin
name: Adela Timmons, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida International University
name: Jonthan Comer, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: