mHealth App for Stress

Overseen By Elizabeth McBride, BA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of California, San Francisco

Disqualifiers: Non-English, Cognitive impairment, No internet, others

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

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health app designed to reduce stress for parents of youth involved in the justice system. The researchers aim to determine if the app can improve youth engagement with substance use treatment once they return to the community. Participants will either use the app or receive standard information on supporting their child during detention and reentry. Caregivers who may qualify have a child aged 12-17 with substance use issues who will soon be released from a juvenile facility into their care. As an unphased trial, this study provides a unique opportunity to contribute to innovative solutions for supporting families during challenging times.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this mHealth parenting stress app is safe?

Research shows that mobile health apps, like the mHealth parenting stress app, are generally safe and easy to use. A review of these apps for parents found no major negative effects, confirming their safety. Previous studies on similar apps, such as the Family Check-Up Online, found that users liked them and reported no significant safety issues.

The study aims to reduce stress for caregivers using a non-invasive method. The trial's "not applicable" phase indicates that the app functions more as a lifestyle change than a medication, usually implying a lower risk of side effects compared to drug trials. Overall, evidence suggests that using the mHealth parenting stress app is likely safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mHealth parenting stress app because it offers a new way to tackle parenting stress, especially during challenging times like an adolescent's detention and community reentry. Unlike traditional methods that rely on brochures and general advice, this app is interactive and can provide tailored support and guidance in real-time. The app aims to not only reduce stress for parents but also improve how young people engage with community-based treatments, potentially leading to better outcomes. This innovative approach harnesses technology for more personalized and immediate support, setting it apart from existing options.

What evidence suggests that the mHealth parenting stress app is effective for reducing parenting stress?

Research shows that helping parents manage stress can improve young people's participation in treatment, especially those with antisocial behavior. In this trial, some participants will use the mHealth parenting stress app, designed to reduce stress for parents of youth involved with the justice system. Studies have shown that similar online tools, like RAISE, effectively lower stress for parents. Reducing parental stress is expected to help these young people continue with their community treatment programs. Although specific data on this app's effectiveness is not yet available, early results from similar tools are encouraging. ^{2 5 6 7 8}

Who Is on the Research Team?

Johanna B Folk, PhD

Principal Investigator

University of California, San Francisco

Are You a Good Fit for This Trial?

This trial is for caregivers of justice-involved youth aged 12-17 with substance use issues. Caregivers must be parents or legal guardians, fluent in English, and have internet access. Excluded are those with cognitive impairments or active psychosis that affects consent ability.

Inclusion Criteria

I am the parent or guardian of a detained youth with substance use needs, aged 12-17, soon to be released to me.

Exclusion Criteria

I am mentally capable of understanding and consenting to participate.

Lack of proficiency in English

Caregivers who do not have access to a device with internet access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development

Development of a mHealth parenting stress intervention using participatory informatics

Not specified

Pilot Randomized Controlled Trial

Evaluate the intervention's preliminary efficacy in reducing parenting stress and increasing youth engagement in treatment

6 months

Follow-up

Participants are monitored for outcomes such as youth treatment engagement and parenting stress

6 months post baseline

What Are the Treatments Tested in This Trial?

Interventions

• mHealth parenting stress app

Trial Overview The study tests a mobile health app designed to reduce parenting stress among caregivers of justice-involved youth who need substance use treatment. It aims to improve treatment engagement by addressing this significant barrier.

How Is the Trial Designed?

Group I: mHealth parenting stress app Experimental Treatment 1 Intervention

mHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement.

Group II: Standard of care Active Control 1 Intervention

Caregiver participants will receive an informational brochure describing ways to support one's adolescent during detention and community reentry and any other usual care.

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials

2,636

Recruited

19,080,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

A scoping review of 16 studies found that pregnancy-specific apps often lack transparency and credibility regarding the information they provide, which raises safety concerns for users.

Key safety considerations identified include the need for better protection of personal data, the importance of evidence-based content, and the necessity for apps to be tailored to local guidelines and users' digital health literacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety considerations for assessing the quality of apps used during pregnancy: A scoping review. Carrandi, A., Hayman, M., Harrison, CL.[2023]

A review of 370 smartphone apps for child nutrition identified 33 that qualified for analysis, revealing that many lack updated information and do not cite their sources, which raises concerns about the reliability of the guidance provided to parents.

Only a small number of apps offer expert consultations or specific nutrient requirements, indicating a lack of uniform guidelines in the development of these applications, which could affect their effectiveness in supporting child nutrition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive overview of smartphone applications delivering child nutrition information. Srivastava, R., Kushwaha, S., Khanna, P., et al.[2022]

The mobile health (mHealth) platform demonstrated an 80.10% accuracy in assessing asthma attack risk using physiological and environmental sensors, indicating its potential effectiveness for asthma self-management in children.

Usability testing showed that children could easily wear and understand the system, suggesting it could be a user-friendly tool for improving asthma management and potentially reducing hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Secure Wireless Sensing Smartwatch Application for the Self-Management of Pediatric Asthma. Hosseini, A., Buonocore, CM., Hashemzadeh, S., et al.[2019]

A study involving 183 parents assessed their preferences for mobile app features related to children's health behaviors, revealing a strong interest in features that enhance communication, motivation, and opportunities for physical activity and diet.

Parents preferred features that promote procedural knowledge, self-monitoring, and goal-setting for physical activity over sleep, indicating a targeted approach could improve the effectiveness of mHealth interventions in pediatric health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parents' Perspectives on the Theoretical Domains Framework Elements Needed in a Pediatric Health Behavior App: A Crowdsourced Social Validity Study. Cushing, CC., Fedele, DA., Brannon, EE., et al.[2020]

A study involving 1850 pregnant women in China found that while many used maternal and child health (MCH) apps, there was no significant association between app use and improved pregnancy outcomes, such as preterm birth or low birth weight.

The research highlighted social disparities in app usage, with nonusers generally being older and having lower education and income levels, emphasizing the need for better app development and testing before clinical recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone App Use Among Pregnant Women in China and Associations Between App Use and Perinatal Outcomes: Retrospective Study. Zhang, P., Chen, H., Shang, J., et al.[2023]

The mobile health technology, Calm Mom, was found to be acceptable and feasible for helping adolescent mothers manage their emotions and stress in real-life situations, as indicated by positive feedback from participants.

While technical challenges limited the use of the wrist-worn sensorband for stress alerts, those who received alerts reported that it significantly aided their emotional regulation and adaptive behavior during stressful interactions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theoretically-Based Emotion Regulation Strategies Using a Mobile App and Wearable Sensor Among Homeless Adolescent Mothers: Acceptability and Feasibility Study. Leonard, NR., Casarjian, B., Fletcher, RR., et al.[2020]

The Analytics Platform to Evaluate Effective Engagement (APEEE) was developed to analyze engagement with the iCanCope app for young people with chronic pain, allowing for real-time data analysis and visualization.

Preliminary evaluations indicated that researchers found APEEE to be a valuable tool for enhancing the assessment of mHealth app engagement, which could lead to more effective and evidence-based care for pediatric chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Analytics Platform to Evaluate Effective Engagement With Pediatric Mobile Health Apps: Design, Development, and Formative Evaluation. Pham, Q., Graham, G., Lalloo, C., et al.[2023]

A user-centered design (UCD) approach was successfully used to develop a mobile health application for Thai women, highlighting that usability is a critical weakness in existing women's m-health applications.

Feedback from both end-users (30 women) and IT experts (13 experts) revealed differing perspectives on usability and functionality, emphasizing the importance of involving both groups in the development process to better meet user expectations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health application for Thai women: investigation and model. Kongjit, C., Nimmolrat, A., Khamaksorn, A.[2022]

A review of 90 mHealth apps for pediatric care identified 27 that met quality assessment criteria, highlighting a lack of comprehensive evaluations in this area.

The top-rated apps, Medscape, Skyscape, and iGuideline, provide reliable resources for healthcare professionals, while the lowest-rated app, PediaBP, indicates variability in app quality and the need for further studies to ensure reliability in pediatric mHealth applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Health Applications for Pediatric Care: Review and Comparison. Morse, SS., Murugiah, MK., Soh, YC., et al.[2020]

A study observing 19 consultations between parents of preterm infants and pediatricians identified key communication themes such as breastfeeding, discharge criteria, and medication, highlighting the importance of these topics in parent-pediatrician interactions.

Both parents and pediatricians expressed a strong interest in a neonatal mHealth app that could enhance communication, with desired features including the ability to ask questions, track growth, and access hospital-specific information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using Digital Communication Technology to Improve Neonatal Care: Two-Part Explorative Needs Assessment. Tenfelde, K., Antheunis, M., Krahmer, E., et al.[2023]

A systematic review of 29 studies on mHealth apps for pregnancy found that many lifestyle apps are usable and effective in promoting healthy behaviors, such as reducing weight gain and increasing fruit and vegetable intake, with 10 out of 19 studies reporting positive acceptability.

While medical mHealth apps showed effectiveness in areas like asthma care and vaccination encouragement, the overall evidence on their effectiveness is limited, indicating a need for further research before widespread implementation in healthcare.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Usability and Effectiveness of Mobile Health Technology-Based Lifestyle and Medical Intervention Apps Supporting Health Care During Pregnancy: Systematic Review. Overdijkink, SB., Velu, AV., Rosman, AN., et al.[2023]

A systematic review of 116 peer-reviewed articles on pediatric health apps revealed that their primary purposes are to support clinical decision-making, patient education, and self-management, with a focus on topics like cancer, obesity, and asthma.

Most of the analyzed apps target children and their caregivers, and the studies assessing these apps predominantly used observational methods, with an average participant sample size of 842, primarily conducted in the USA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pediatric apps: what are they for? A scoping review. Nievas Soriano, BJ., Uribe-Toril, J., Ruiz-Real, JL., et al.[2022]

The paper presents a systematic method for developing mHealth interventions that are tailored to the needs of child-parent dyads, ensuring that these interventions are more accessible and effective for health behavior change.

It introduces the Website Analysis and MeasureMent Inventory framework to analyze qualitative data, which can enhance user engagement and appeal, exemplified by its application in creating a mobile app for children with sickle cell disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An approach to revising mHealth interventions for children and families: A case example in sickle cell disease. Phillips, S., Kanter, J., Ruggiero, KJ., et al.[2021]

A usability test of a mobile health app designed for cancer patients showed a high system usability score of 92.5, indicating that most participants could easily navigate the app to report chemotherapy side effects.

While the app has the potential to enhance patient safety and empower users, some patients may struggle with smartphone apps due to their age or health conditions, suggesting that alternative support methods are necessary for comprehensive patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, Development, and Evaluation of an mHealth App for Reporting of Side Effects During Cytostatic Treatment: Usability Test and Interview Study. Hægermark, EA., Kongshaug, N., Raj, SX., et al.[2023]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05032742?utm_source=trialradar

Study Details | NCT05032742 | Parenting Stress mHealth Addressing parenting stress improves youth treatment engagement and outcomes among youth exhibiting antisocial behavior, yet given the many barriers to ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40638918/

Stress Management Among Caregivers of Detained Youth RAISE (Reducing pArentIng StrEss) is a web-based application co-designed with caregivers of detained adolescents to reduce caregiver stress and ...

3. researchprotocols.org researchprotocols.org/2025/1/e67511

Stress Management Among Caregivers of Detained Youth RAISE is a web-based app designed to reduce stress in caregivers of detained youth, including an 8-week stress reduction intervention and self- ...

4. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT05032742

UCSF Mental Health Trial → Parenting Stress mHealth The current project aims to develop and evaluate a mobile health parenting stress intervention for caregivers of justice-involved youth.

5. withpower.com withpower.com/trial/mhealth-app-for-stress-00159

mHealth App for Stress Trial Overview The study tests a mobile health app designed to reduce parenting stress among caregivers of justice-involved youth who need substance use ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314697/

A systematic review and evaluation of mobile health apps ... The objective of this systematic review was to identify and evaluate the quality of publicly available mHealth apps designed for parents who are ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0885200624001364

Family Check-Up Online effects on parenting and ... The current study evaluates the efficacy of a mobile app-based parenting support program, the Family Check-Up Online (FCU-O) with telehealth coaching support, ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12167330/

mHealth Applications for Childhood Anxiety Disorders We review the literature on mHealth applications for childhood anxiety disorders, highlighting current use, limitations, and future directions.