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

Trial Summary

What is the purpose of this trial?

Parenting stress is a well-documented barrier to youth engagement in community-based substance use treatment. The current project aims to develop and evaluate a mobile health parenting stress intervention for caregivers of justice-involved youth, a population with high rates of substance use and low rates of treatment engagement.

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 data supports the effectiveness of the mHealth parenting stress app treatment?

While there is no direct evidence for the mHealth parenting stress app, research shows that mobile health apps can help with patient education and self-management, especially in chronic conditions like asthma and obesity. This suggests that similar apps could potentially help parents manage stress by providing education and self-management tools. ^{1 2 3 4 5}

Is the mHealth App for Stress safe for use in humans?

There is no specific safety data available for the mHealth App for Stress or its related versions in the provided research articles. ^{1 6 7 8 9}

How is the mHealth Parenting Stress App treatment different from other stress treatments?

The mHealth Parenting Stress App is unique because it uses mobile technology to provide real-time support and emotion regulation strategies for parents, especially in stressful situations, unlike traditional treatments that may not offer immediate or on-the-go assistance. ^{10 11 12 13 14}

Research Team

Johanna B Folk, PhD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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.

I am a behavioral health provider or juvenile probation officer, over 18, and speak English fluently.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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 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]

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 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 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 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]

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]

References

1. Canada 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. [2020]

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

An Analytics Platform to Evaluate Effective Engagement With Pediatric Mobile Health Apps: Design, Development, and Formative Evaluation. [2023]

3. Germany pubmed.ncbi.nlm.nih.gov

Pediatric apps: what are they for? A scoping review. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

An approach to revising mHealth interventions for children and families: A case example in sickle cell disease. [2021]

5. Canada 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. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Secure Wireless Sensing Smartwatch Application for the Self-Management of Pediatric Asthma. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Comprehensive overview of smartphone applications delivering child nutrition information. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Mobile Health Applications for Pediatric Care: Review and Comparison. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Safety considerations for assessing the quality of apps used during pregnancy: A scoping review. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Mobile health application for Thai women: investigation and model. [2022]

11. Canada pubmed.ncbi.nlm.nih.gov

Mobile Phone App Use Among Pregnant Women in China and Associations Between App Use and Perinatal Outcomes: Retrospective Study. [2023]

12. Canada 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. [2020]

13. Canada pubmed.ncbi.nlm.nih.gov

Using Digital Communication Technology to Improve Neonatal Care: Two-Part Explorative Needs Assessment. [2023]

14. Canada 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. [2023]