Mental Health and Well-beingNCT06443918

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

A study testing A Just-in-Time Adaptive Intervention for Child and Family Mental Health in people with Mental Health and Well-being and Family Functioning, run by Colliga Apps Corp. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 6 years and older
Conditions the study is for: Mental Health and Well-being, Family Functioning
What is being tested?: A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 347 participants
Where: 2 sitesUnited States
Study dates: 20 May 2024to 14 Jan 2026
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

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

Other trials in United States

About this study

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.

Read the 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.

Conditions: Mental Health and Well-being, Family Functioning
Being tested: A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Keywords: Mental health and well-being, Child development, Digital mental health, Digital intervention, Family functioning
Medical subject headings: Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06443918
Study group	Role	What they receive
Intervention	Experimental	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. Receives: Behavioral: A Just-in-Time Adaptive Intervention for Child and Family Mental Health
Control group	No intervention	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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 weeks

Secondary outcomes (6)

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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 202414 Jan 2026

First posted5 Jun 2024
Study start20 May 2024
Primary completion14 Jan 2026
Study completion14 Jan 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Mental Health and Well-beingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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).
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 347 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06443918
Sponsor's protocol ID: R44MH123368
Other IDs: R44MH123368
Status last verified: Mar 2026
First submitted: 23 Feb 2024
Last updated: 10 Mar 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Researchers can request access to data through Colliga's website by filling out a request form at: https://colliga.io/repository/.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Just-in-Time Adaptive Intervention for Child and Family Mental Health
ClinicalTrials.gov ID: NCT06443918
Acronym / sponsor ID: R44MH123368
Conditions: Mental Health and Well-being, Family Functioning
Keywords: Mental health and well-being, Child development, Digital mental health, Digital intervention, Family functioning
Study type: Interventional
Recruitment status: Completed
Enrolment: 347 participants (actual)
Lead sponsor: Colliga Apps Corp.Industry (pharma, biotech, devices)
Collaborators: National Institute of Mental Health (NIMH)
Study start: 20 May 2024 (actual)
Primary completion: 14 Jan 2026 (actual)
Study completion: 14 Jan 2026 (actual)
First posted: 5 Jun 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2
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).

Arm	Type	Receives
Intervention	Experimental	Behavioral: A Just-in-Time Adaptive Intervention for Child and Family Mental HealthThe 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.
Control group	No intervention	–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.

Who may qualify

Ages: 6 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
A Just-in-Time Adaptive Intervention for Child and Family Mental HealthFamilies 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.	Behavioural	Intervention

Primary outcome

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.

6 secondary outcomes

Child externalizing symptoms, measured by the Child Behavior Checklist (CBCL) Externalizing Problems scale
Time frame: 8 weeks
Caregiver mental health symptoms, measured by the 27-Plus (SCL-27-Plus) total score
Time frame: 8 weeks
Child attachment
Time frame: 8 weeks
Caregiver attachment
Time frame: 8 weeks
Parent-child aggression
Time frame: 8 weeks
Inter-parental aggression
Time frame: 8 weeks

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
Colliga Apps websiteLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Researchers can request access to data through Colliga's website by filling out a request form at: https://colliga.io/repository/.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matthew Ahle, B.S. principal investigator

Colliga Apps

Adela Timmons, Ph.D. principal investigator

The University of Texas at Austin

Jonthan Comer, Ph.D. principal investigator

Florida International University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in child internalizing symptoms, measured by the Child Behavior Checklist (CBCL) Internalizing Problems scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06443918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.