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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment A Just-in-Time Adaptive Intervention for Child and Family Mental Health?

Research shows that Just-in-Time Adaptive Interventions (JITAIs) in mobile health apps can effectively help manage mental health conditions like depression and anxiety by providing timely support. These interventions are designed to improve treatment effectiveness and user engagement by offering the right help at the right moment. ^{1 2 3 4 5}

Is the mobile app for family mental health safe for humans?

The research articles do not provide specific safety data for the mobile app for family mental health or its related interventions. They focus on the design, development, and feasibility of similar mental health apps, but do not mention any safety concerns. ^{1 5 6 7 8}

How is the JITAI treatment for family mental health different from other treatments?

The JITAI treatment is unique because it uses a mobile app to provide personalized, real-time support for child and family mental health, adapting to the user's needs as they change. This approach enhances engagement and effectiveness by delivering interventions exactly when they are needed, unlike traditional treatments that follow a fixed schedule. ^{3 4 7 9 10}

Research Team

Adela Timmons, Ph.D.

Principal Investigator

The University of Texas at Austin

Jonthan Comer, Ph.D.

Principal Investigator

Florida International University

Matthew Ahle, B.S.

Principal Investigator

Colliga Apps

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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 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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Adapting a Psychosocial Intervention for Smartphone Delivery to Middle-Aged and Older Adults with Serious Mental Illness. [2019]

2. Canada pubmed.ncbi.nlm.nih.gov

Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review. [2023]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. [2022]

4. Canada 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. [2022]

5. United States 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. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

OpenSIMPLe: A real-world implementation feasibility study of a smartphone-based psychoeducation programme for bipolar disorder. [2019]

7. Australia pubmed.ncbi.nlm.nih.gov

Using a mobile phone application in youth mental health - an evaluation study. [2019]

8. Switzerland 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. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Youth and Provider Perspectives on Behavior-Tracking Mobile Apps: Qualitative Analysis. [2021]

10. Switzerland 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. [2023]