Mobile App for Family Mental Health

Recruiting at 1 trial location

Overseen By Adela Timmons, Ph.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Colliga Apps Corp.

Disqualifiers: Suicidal ideation, Homicidal ideation, Child abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

357 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to improve mental health and family relationships. The app provides real-time feedback and activities to guide families and promote better interactions. As a Just-in-Time Adaptive Intervention (JITAI), it offers personalized support at the right moments. Researchers will divide participants into two groups—one using the actual app and the other using a placebo version—to determine the app's effectiveness. Families with a child aged 6-9 who have faced mental health challenges and meet certain income or ethnic criteria may be eligible, particularly those living in Texas or Florida. This unphased trial offers families the chance to contribute to innovative mental health solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on using an app to improve mental health, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that this app-based intervention is safe for improving child and family mental health?

Research has shown that Just-in-Time Adaptive Interventions (JITAIs) are generally safe and well-tolerated. These interventions adjust in real-time to offer support when needed most and have been used in various health settings without reports of serious side effects.

The mobile app for family mental health is a type of JITAI. It uses a smartphone to provide information about psychology and activities to improve family interactions. This method is non-invasive, meaning it doesn't involve physical procedures or medication.

Since this trial is not in a clinical phase, it focuses more on how the app can help rather than testing unknown risks. JITAIs have been studied in other areas, demonstrating they can be a safe way to support mental health and well-being. ^{1 2 3 4}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a novel use of technology to support family mental health. Unlike traditional therapy options that require in-person visits, this approach delivers psychoeducation and family-based activities through a smartphone app, allowing for real-time coaching of family interactions. This just-in-time adaptive intervention (JITAI) is designed to provide timely support tailored to the family’s immediate needs, which could lead to more effective and responsive mental health care. By utilizing smartwatches to monitor heart rate, activity levels, and sleep, this trial aims to gather comprehensive data that could offer insights into the dynamics of family mental health and improve intervention strategies.

What evidence suggests that this app-based intervention is effective for improving child and family mental health?

Research has shown that Just-in-Time Adaptive Interventions (JITAIs), tested in this trial, can greatly improve mental health. These interventions use real-time feedback to guide families, enhancing mental health and behavior. Studies suggest JITAIs can lead to moderate-to-large improvements in these areas. In this trial, the intervention arm will use JITAIs to deliver mental health education and activities through a smartphone app, aiming to enhance family functioning and overall well-being. ^{1 3 5 6}

Who Is on the Research Team?

Adela Timmons, Ph.D.

Principal Investigator

The University of Texas at Austin

Matthew Ahle, B.S.

Principal Investigator

Colliga Apps

Jonthan Comer, Ph.D.

Principal Investigator

Florida International University

Are You a Good Fit for This Trial?

This trial is for families looking to improve their mental health and family functioning. Participants will need a smartphone to download an app for the intervention sessions.

Inclusion Criteria

Family income less than or equal to the 33rd percentile for their county of residence

At least one participating family member identifies as belonging to an ethnic/racial minoritized group

Child mental health symptoms at or above the 70th percentile based on any subscale of the Strengths and Difficulties Questionnaire

Exclusion Criteria

Active homicidal ideation

Current child abuse

Current violence in the home

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in an 8-week app-based intervention with daily psychoeducation modules, JITAI sessions, and bi-weekly check-ins

8 weeks

Bi-weekly check-ins (virtual)

Follow-up

Participants are monitored for changes in mental health and family functioning through follow-up questionnaires

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The study tests an app-based just-in-time adaptive intervention (JITAI) designed to provide immediate feedback and coaching to enhance child and family mental health, comparing its effectiveness with a control group.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 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.

Group II: Control group Active Control 1 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 Is Running the Clinical Trial?

Colliga Apps Corp.

Lead Sponsor

Trials

1

Recruited

360+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A smartphone application for self-management was successfully adapted for middle-aged and older adults with serious mental illness, showing high usability and satisfaction among participants (mean age 55.3 years).

The study indicates that older adults with serious mental illness can effectively engage with tailored smartphone interventions, suggesting potential for these tools in community-based mental health services, although further research is needed to assess their effectiveness and necessary clinical support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting a Psychosocial Intervention for Smartphone Delivery to Middle-Aged and Older Adults with Serious Mental Illness. Fortuna, KL., Lohman, MC., Gill, LE., et al.[2019]

A smartphone-based psychoeducational program for bipolar disorder showed that 62% of users were satisfied, particularly among those who completed the program, indicating potential effectiveness in user engagement.

Despite positive outcomes in well-being and health domains after 6 months, the program had a high attrition rate of 66.2%, with older age being a predictor of better retention, highlighting the need for further research on improving retention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

OpenSIMPLe: A real-world implementation feasibility study of a smartphone-based psychoeducation programme for bipolar disorder. Hidalgo-Mazzei, D., Reinares, M., Mateu, A., et al.[2019]

A systematic review of 15 studies with 2627 participants found that app-based mHealth interventions significantly reduced anxiety symptoms, particularly when the interventions lasted at least 7 weeks, but showed no significant effect on depression symptoms.

Despite some positive effects on anxiety, the overall evidence for the clinical use of these mHealth interventions is inconclusive due to small effect sizes and concerns about study quality, indicating a need for further research on optimal treatment duration and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness and Minimum Effective Dose of App-Based Mobile Health Interventions for Anxiety and Depression Symptom Reduction: Systematic Review and Meta-Analysis. Lu, SC., Xu, M., Wang, M., et al.[2022]

Both youth and mental health providers agree that mobile health apps, particularly behavior-tracking apps, could enhance psychotherapy by making it more enjoyable and accessible.

Concerns were raised about the potential burden of using these apps, particularly regarding negative emotions and user fatigue, highlighting the need for user-friendly features to encourage long-term engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Youth and Provider Perspectives on Behavior-Tracking Mobile Apps: Qualitative Analysis. Armstrong, CC., Odukoya, EJ., Sundaramurthy, K., et al.[2021]

A pilot study involving 22 adolescents and their parents showed that integrating a mobile app with family-focused therapy (FFT) led to significant improvements in depression scores over 27 weeks, indicating the potential efficacy of this approach.

Participants engaged with the app, completing 46%-65% of assessments and skill practices, and reported reduced parental criticism, suggesting that mobile apps can enhance treatment engagement and provide valuable feedback for clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. Miklowitz, DJ., Weintraub, MJ., Posta, F., et al.[2022]

POD Adventures is a blended problem-solving game-based intervention designed for adolescents in India, developed through extensive stakeholder engagement and user-testing with 126 participants, including students and service providers.

The intervention aims to provide accessible mental health support through a gamified app, emphasizing relatability and interactivity, and will be evaluated in a randomized controlled trial to assess its effectiveness in low-resource school settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design and Development of the "POD Adventures" Smartphone Game: A Blended Problem-Solving Intervention for Adolescent Mental Health in India. Gonsalves, PP., Hodgson, ES., Kumar, A., et al.[2023]

The SPARK intervention, which uses tablet-assisted interactive games and activities, aims to enhance provider fidelity and child engagement in evidence-based psychotherapies, potentially improving the quality of mental health care for children.

This study employs a hybrid effectiveness-implementation trial design across over two dozen community practice settings, allowing researchers to evaluate both the effectiveness of the SPARK intervention and the challenges of implementing technology in existing mental health clinics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid type 1 randomized controlled trial of a tablet-based application to improve quality of care in child mental health treatment. Anton, MT., Ridings, LE., Hanson, R., et al.[2021]

A mobile phone self-monitoring tool for mental health was used by 47 adolescents over 2-4 weeks, showing high engagement with 91% of entries completed in the first week.

Paediatricians found the tool beneficial, with 92% of them reporting it helped them understand their patients better, and 88% of participants felt the data accurately reflected their experiences.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a mobile phone application in youth mental health - an evaluation study. Reid, SC., Kauer, SD., Khor, AS., et al.[2019]

A scoping review of 32 articles revealed that eHealth applications can effectively promote child mental health in low- and middle-income countries (LMICs), focusing on interventions for families, school mental health services, and pediatric care systems.

Most eHealth studies reported positive outcomes, indicating that while many were conducted in high-income countries, their design strategies can be adapted for LMICs, highlighting the need for more research to test these strategies in diverse contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Technology to Promote Child Behavioral Health in the Context of Pediatric Care: A Scoping Review and Applications to Low- and Middle-Income Countries. Huang, KY., Lee, D., Nakigudde, J., et al.[2023]

A review of 28 popular smartphone apps for depression found that none utilized just-in-time adaptive intervention (JITAI) mechanisms, which are designed to provide tailored support based on an individual's state of vulnerability and receptivity.

Most apps relied on self-reported outcomes (71%) but did not use these measurements to customize content or timing, indicating a significant gap in leveraging the potential of JITAI mechanisms to enhance the effectiveness of depression interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review. Teepe, GW., Da Fonseca, A., Kleim, B., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06443918

A Just-in-Time Adaptive Intervention for Child and Family ... The intervention aims to improve child and family mental health and functioning through psychoeducation and family-based activities delivered via a smartphone ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11862764/

Just-In-Time Adaptive Interventions to Promote Behavioral ... This study aims to systematically review the literature to describe the landscape of existing JITAIs for behavioral health at any stage of intervention ...

3. jahonline.org jahonline.org/article/S1054-139X(25)00367-2/fulltext

Just-in-Time Adaptive Interventions for Adolescent and ... Meta-analyses indicate JITAIs can yield moderate-to-large improvements in behavioral and mental health outcomes [13,14], though no such review ...

4. trialx.com trialx.com/clinical-trials/listings/292363/a-just-in-time-adaptive-intervention-for-child-and-family-mental-health/?&radius=10&place=A&user_country=Concord%20N

A Just-in-Time Adaptive Intervention for Child and Family ... The intervention aims to improve child and family mental health. A JITAI provides in-the-moment feedback to coach families. The questions it ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5364076/

Just-in-Time Adaptive Interventions (JITAIs) in Mobile Health JITAI is an intervention design aiming to provide the right type/amount of support, at the right time, by adapting to an individual's changing internal and ...

6. researchprotocols.org researchprotocols.org/2025/1/e58917

Just-In-Time Adaptive Interventions to Promote Behavioral ... This study aims to systematically review the literature to describe the landscape of existing JITAIs for behavioral health at any stage of intervention ...