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

NCT06443918 | Completed DMC

• 1 other identifier: R44MH123368
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 2

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.

Conditions

Mental Health and Well-being; Family Functioning

Keywords

Mental health and well-being; Child development; Digital mental health; Digital intervention; Family functioning

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Child externalizing symptoms, measured by the Child Behavior Checklist (CBCL) Externalizing Problems scale

  8 weeks

• Caregiver mental health symptoms, measured by the 27-Plus (SCL-27-Plus) total score

  8 weeks

• Child attachment

  8 weeks

• Caregiver attachment

  8 weeks

• Parent-child aggression

  8 weeks

Other Outcomes (11)

• Anxious/ depressed

  8 weeks

• Withdrawn/ depressed

  8 weeks

• Other child syndrome-level symptoms

  8 weeks

Study Arms (2)

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.

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.

Interventions

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

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.

Intervention

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Active suicidal ideation OR
• Active homicidal ideation OR
• Current child abuse OR
• Current violence in the home

Sponsors & Collaborators

• Colliga Apps Corp.: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Florida International University

Miami, Florida, 33199, United States

Location

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Links

• Colliga Apps website

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants will be informed during consent that they will have a 50-50 chance of receiving the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 23, 2024
• First Posted: June 5, 2024
• Study Start: May 20, 2024
• Primary Completion: January 14, 2026
• Study Completion: January 14, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• 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.

Locations

US (2)