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

March 6, 2026 updated by: Colliga Apps Corp.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
347

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in child internalizing symptoms, measured by the Child Behavior Checklist (CBCL) Internalizing Problems scale
Time Frame: 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.
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Child externalizing symptoms, measured by the Child Behavior Checklist (CBCL) Externalizing Problems scale
Time Frame: 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.
8 weeks
Caregiver mental health symptoms, measured by the 27-Plus (SCL-27-Plus) total score
Time Frame: 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.
8 weeks
Child attachment
Time Frame: 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
8 weeks
Caregiver attachment
Time Frame: 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.
8 weeks
Parent-child aggression
Time Frame: 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.
8 weeks
Inter-parental aggression
Time Frame: 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.
8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Anxious/ depressed
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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
Time Frame: 8 weeks
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Colliga Apps Corp.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Mental Health (NIMH)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 14, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 5, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 10, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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