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

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.

Study Overview

• Status: Completed
• Conditions: Family Functioning; Mental Health and Well-being
• Intervention / Treatment: Behavioral: A Just-in-Time Adaptive Intervention for Child and Family 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.

• Study Type: Interventional
• Enrollment (Actual): 347
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33199
      • Florida International University
  • Texas
    • Austin, Texas, United States, 78712
      • The University of Texas at Austin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention aims to improve child and family mental health and functioning through psychoeducation and family-based activities delivered via a smartphone app. This intervention also includes a just-in-time adaptive intervention (JITAI) for coaching family interactions in real-time. Caregivers will wear smartwatches and carry smartphones for 8 weeks. Children will wear smartwatches. A variety of types of data will be collected from the phones and watches, such as heart rate, activity levels, and sleep. We will also collect daily surveys, daily audio recordings, a 15-minute survey every 2 weeks about their experiences using the app, and check-in calls every 2 weeks.	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.
No Intervention: Control group; Caregivers will wear smartwatches and carry smartphones for 8 weeks. Children will wear smartwatches. Participants will complete placebo psychoeducational modules matched in length and reading level to the intervention content. A variety of types of data will be collected from the phones and watches, such as heart rate, activity levels, and sleep. We will also collect daily surveys, daily audio recordings, a 15-minute survey every 2 weeks about their experiences using the app, and check-in calls every 2 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in child internalizing symptoms, measured by the Child Behavior Checklist (CBCL) Internalizing Problems scale	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Child externalizing symptoms, measured by the Child Behavior Checklist (CBCL) Externalizing Problems scale	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.	8 weeks
Caregiver mental health symptoms, measured by the 27-Plus (SCL-27-Plus) total score	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.	8 weeks
Child attachment	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	8 weeks
Caregiver attachment	Measures the frequency and severity of aggressive or harsh behaviors occurring within the parent-child relationship using the Conflict Tactics Scale Parent-Child version.	8 weeks
Parent-child aggression	Measures the frequency and severity of aggressive or harsh behaviors occurring within the parent-child relationship using the Conflict Tactics Scale Parent-Child version.	8 weeks
Inter-parental aggression	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.	8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxious/ depressed	Examines caregiver-reported child anxious/depressed symptoms using the CBCL Anxious/Depressed syndrome subscale to characterize symptom-specific changes over time.	8 weeks
Withdrawn/ depressed	Assesses caregiver-reported child withdrawn/depressed behaviors using the CBCL Withdrawn/Depressed syndrome subscale to evaluate patterns of social withdrawal and depressive features.	8 weeks
Other child syndrome-level symptoms	Evaluates additional CBCL syndrome-level symptom domains to descriptively characterize broader child symptom profiles and trajectories across the intervention period.	8 weeks
Caregiver syndrome-level symptoms	Assesses caregiver psychological symptom patterns across syndrome-level domains of the Symptom Checklist-27-Plus to describe changes in specific areas of caregiver distress.	8 weeks
Child health symptoms	Evaluates caregiver-reported child physical and health-related symptoms using the Child Health Questionnaire to characterize changes in child health functioning.	8 weeks
Caregiver health symptoms	Assesses caregiver self-reported physical or somatic symptoms using the Physical Health Questionnaire to examine potential changes in caregiver health status.	8 weeks
Daily symptom trajectories	Characterizes longitudinal patterns of caregiver- and/or child-reported symptoms collected via repeated daily surveys across the intervention period to examine within-person symptom dynamics.	8 weeks
Engagement	Describes participant interaction with the digital intervention, including module completion, AI coaching session use, and survey completion, using backend application analytics to characterize adherence and exposure.	8 weeks
Immediate mood symptoms and family interactional quality following reported skill use	Examines proximal changes in self-reported mood and perceived family interaction quality immediately following participant-reported use of intervention skills using in-app daily assessments.	8 weeks
Immediate mood symptoms and family interactional quality following module sessions	Evaluates short-term changes in mood and perceived family functioning immediately after completion of intervention modules using module-based surveys.	8 weeks
Immediate sentiments detected following AI-coaching prompts	Characterizes participant sentiment derived from AI-assisted coaching interactions using Microsoft Azure natural language processing to detect positive, negative, and neutral sentiment during parent-child play sessions.	8 weeks

Collaborators and Investigators

• Sponsor: Colliga Apps Corp.
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Matthew Ahle, B.S., Colliga Apps; Principal Investigator: Adela Timmons, Ph.D., The University of Texas at Austin; Principal Investigator: Jonthan Comer, Ph.D., Florida International University

Publications and helpful links

Helpful Links

• Colliga Apps website

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2024
• Primary Completion (Actual): January 14, 2026
• Study Completion (Actual): January 14, 2026

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Child development; Family functioning; Digital intervention; Digital mental health; Mental health and well-being
• Additional Relevant MeSH Terms: Behavior; Personal Satisfaction; Psychological Well-Being
• Other Study ID Numbers: R44MH123368 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Researchers can request access to data through Colliga's website by filling out a request form at: https://colliga.io/repository/.
• IPD Sharing Time Frame: Data will become available within 1 year after the completion of the clinical trial. Individual requests for data access will be processed within 3 months. Data will be available for individual researchers' use for 1 year with an opportunity to renew yearly. The repository will be maintained for at least 3 years.
• IPD Sharing Access Criteria: Requests can be submitted by providing the researcher's name, contact information, desired date of dataset access, and explanation for the use of data. Colliga Apps administrators will process requests and give access to approved and verified researchers after the completion of a data use agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No