An interventional study of MoodRing App and Usual Care in Depression in Adolescence, sponsored by Ana Radovic. Terminated at 1 site in United States. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Ana Radovic · Not applicable, Interventional, and Health services research
The MoodRing intervention is a mobile application for adolescents, parents, and an accompanying web-based clinician portal which enables adolescents to monitor their mood through the use of passively collected smartphone data. This randomized controlled trial will evaluate whether MoodRing as compared to usual care improves the quality of depression management.
This is a randomized controlled trial to evaluate the efficacy of MoodRing as compared to usual care for adolescents who have a prior diagnosis of depression. Adolescents with depressive symptoms, their parents, and their mental healthcare providers (if interested) will participate in a 6 month study. Adolescents age 12-18 and their parent will be consented for the study and be sent an online survey to obtain baseline measures. Those who complete the baseline measures will then be randomized to receive the MoodRing intervention or treatment as usual. Adolescents and parents will be asked to complete data collection at 3 months and 6 month time points post-randomization by online survey. Additionally, data will be collected for 3 and 6 month timepoints via the adolescent's electronic health record data. At 6 months, online surveys will be sent and an invitation to interview for patients' mental healthcare providers who consent to participate in the study.
Adolescent-parent dyads will be randomized at a 1:1 ratio (using randomized block sizes) to either 1) MoodRing or 2) usual care. 100 adolescent-parent dyads (200 total individuals) will be randomized to MoodRing and 100 adolescent-parent dyads (200 total individuals) will be randomized to usual care. We expect 50 clinicians will participate. In both arms, passively collected data will be obtained from adolescent smartphones as well as weekly mood surveys and monthly sleep surveys. In the 1) MoodRing arm adolescents will download the MoodRing-adolescent app, parents will download the MoodRing-parent app, and healthcare providers if interested will have access to a clinician dashboard. The randomization tables will be generated by the study statistician.
The investigators hypothesize that adolescents who receive MoodRing as compared to usual care will have:
H1: Improved self-management of depression as measured by change of baseline for the average score on the Partners in Health Scale
EH2: The investigators will also explore whether MoodRing as compared to usual care will result in improved quality of depression management as measured by frequency of symptom reassessment, medication adherence, and therapy adherence, less healthcare utilization, decreased depression symptoms, improved sleep quality, and increased application of self-management activities through increased self-efficacy, utilization of self-management skills and knowledge and social support.
H3: The investigators anticipate healthcare providers, adolescents, and parents will report satisfaction with use of MoodRing.
* After date September 2022, we decided to make a change to the protocol and primary outcome. Due to recruitment challenges from mental health clinicians due to their clinical workload, we made a change to recruit adolescents directly including using social media. This introduced more heterogeneity to access to mental health care as well as less access to electronic health records systems that were external to our site which made it less likely to be able to measure quality of depression management. For this reason, the goal to recruit healthcare providers was discontinued. And the primary outcome was changed to self-management, changing our hypothesis to:
We hypothesized that MoodRing will help adolescents better self-manage their depression.
Secondary outcome measures were changed from "change in symptoms" to just that symptom total at 3 months and 6 months for better clinical interpretability.
This is the only study on the registry with Ana Radovic as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Adolescent:
Parent/Guardian:
Healthcare Provider:
- involved in providing mental health treatment (psychotherapy or antidepressant prescribing or making referrals) to adolescent participant - can be a primary care provider, therapist, subspecialist, psychiatrist
Exclusion Criteria:
Adolescent:
Parent:
- If their adolescent child is excluded
Healthcare Provider:
- None
Participants in this arm will receive no intervention and access treatment as usual per their mental health services provider. A mobile application (AWARE) which is not interactive and is only for purposes of data collection will be downloaded on the adolescents' smartphone.
Other: Usual Care
Adolescent participants in this arm will download two mobile applications - a data collection non-interactive app to collect passive sensing data (AWARE) and the MoodRing (MR) mobile application with which they can visualize their data about their mood, sleep, activity, enter their own mood score, and access psychoeducational resources including links to a research-based website, SOVA. Their parents will download a parent MoodRing application which provides them with parenting resources and articles and a weekly report of their adolescents' mood as predicted by passive sensing. Clinical providers will receive access to a web portal where they can view their adolescent patients' data who are enrolled in the study.
Device: MoodRing App
Adolescents and parents in the MR arm will receive instructions to download the MR app and AWARE app, customize the app, utilize an app-based self-guided onboarding, and review questions with the research team. The MR app provides the adolescent and their parent a notification to view a weekly report predicting their mood score (i.e. depression severity level similar to the Patient health questionnaire-9). The MR app will provide a library of coping strategies for adolescents and opportunities to self-track their mood. Clinicians in the MR Arm will get access to a MR portal online. They will be able to view patients they are a provider for. The clinician will receive in-person and/or video-based training to use the portal.
Adolescents and parents in the usual care arm will receive instructions to download the AWARE app. This app will only track data and will not be interactive. Otherwise they will receive care as per routine by their healthcare provider team.
Change From Baseline in Self-management at 3 Months
Adolescents will be asked the Partners in Health Scale The revised Partners in Health Scale (Smith 2016) assesses self-management with respect to a chronic condition, with regard to active involvement of a patient in managing their condition. Total scores range from 0 to 96 with higher scores indicating worse self-management. A larger negative change in self-management score means an improvement in self-management.
Time frame: From baseline to 3 months
Quality of Depression Management: Depression Symptom Reassessment
Attendance at a healthcare provider visit for depression symptom reassessment within 3 months (yes/no) measured by adolescent or parent self-report (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 3 months
Quality of Depression Management: Medication Adherence
Out of adolescents who are taking an antidepressant, receipt of at least 60 consecutive days (yes/no) measured by adolescent self-report. The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 3 months
Quality of Depression Management: Therapy Adherence
Out of adolescents who report being referred for psychotherapy, receipt of at least 3 sessions within 3 months (yes/no) measured by adolescent and parent self-report (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 3 months
Healthcare Utilization for Acute Care or Primary Care (for Non Mental-health Reason)
Average Number of visits for (greater number as reported by adolescent self-report and parent self-report): 1. urgent care; 2. emergency room; 3. inpatient hospitalization; 4. acute primary care provider visit for non-mental health related concern; 5. medical subspecialist visit 6. surgical subspecialist visit
Time frame: 3 month
Depression Severity at 3 Months
Adolescents will be asked the PHQ-9 Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
Time frame: 3 months
Sleep-Related Impairment at 3 Months
Adolescents will respond to the PROMIS Pediatric Sleep-Related Impairment scale. This scale has four questions with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 19 with higher scores indicating higher levels of sleep-related impairment.
Time frame: 3 months
Sleep Disturbance at 3 Months
Adolescents will respond to the PROMIS Pediatric Sleep Disturbance scale. This scale has four questions, the second (sleeping through the night) being reverse-scored, with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 20 with higher scores indicating higher levels of sleep disturbance.
Time frame: 3 months
Self-Efficacy at 3 Months
Adolescents will be asked the Mental Health Self-efficacy Scale (MHSES) The Mental Health Self-efficacy Scale (Clarke, 2014) measures one's belief in one's capability to perform mental health self-care behaviors. The score ranges from 6 to 60, with higher scores indicating higher confidence in mental health selfcare.
Time frame: 3 months
Self-management Behavior at 3 Months
Adolescents will be asked based on Question 12 of Partners in Health Scale about self-management behavior. This question asks the average amount of time (options including Daily, More than once a week, Once a week, Once a month, Once a semester, Once a year, Less than once a year, Never) spent in potentially useful self-management activities. Each time category will be described by a percentage. Each of the following are asked individually: (1) created to-do lists to help me focus; (2) found strategies to create pleasurable distractions; (3) engaged in some physical activity (cycling, walking, etc.); (4) set realistic short-term goals; (5) made sure I had a good day/night routine with got enough sleep; (6) ensured enough rest to avoid getting exhausted; (7) left the house regularly; (8) ate healthy A higher score indicates a better outcome.
Time frame: 3 months
Social Support at 3 Months
Adolescents will be asked the Medical Outcomes Study Social Support Survey The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. Each item ranges from 1 to 5 and the total score is averaged and ranges from 1 to 5, with higher levels associated with greater support.
Time frame: 3 months
Change in Self-management at 6 Months
Adolescents will be asked the Partners in Health Scale The revised Partners in Health Scale (Smith 2016) assesses self-management with respect to a chronic condition, with regard to active involvement of a patient in managing their condition. Total scores range from 0 to 96 with higher scores indicating worse self-management. A larger negative change in self-management score means an improvement in self-management.
Time frame: From baseline to 6 months
Quality of Depression Management: Depression Symptom Reassessment
Attendance at a healthcare provider visit for depression symptom reassessment within the past 3 months (yes/no) measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 6 months
Quality of Depression Management: Medication Adherence
Out of adolescents who are taking an antidepressant, receipt of at least 60 consecutive days (yes/no) within the past 3 months, measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 6 months
Quality of Depression Management: Therapy Adherence
Out of adolescents who are referred for psychotherapy, receipt of at least 3 sessions within the past 3 months (yes/no) measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
Time frame: 6 months
Healthcare Utilization for Acute Care or Primary Care (for Non Mental-health Reason)
Number of visits for (combined total between adolescent self-report, parent self-report, and electronic health-record review): 1. urgent care; 2. emergency room; 3. inpatient hospitalization; 4. acute primary care provider visit for non-mental health related concern; 5. medical or surgical subspecialist visit
Time frame: 6 month
Depression Severity at 6 Months
Adolescents will be asked the PHQ-9 Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
Time frame: 6 months
Self-management Behavior at 6 Months
Adolescents will be asked based on Question 12 of Partners in Health Scale about self-management behavior. This question asks the average amount of time (options including Daily, More than once a week, Once a week, Once a month, Once a semester, Once a year, Less than once a year, Never) spent in potentially useful self-management activities. Each of the following are asked individually: (1) created to-do lists to help me focus; (2) found strategies to create pleasurable distractions; (3) engaged in some physical activity (cycling, walking, etc.); (4) set realistic short-term goals; (5) made sure I had a good day/night routine with got enough sleep; (6) ensured enough rest to avoid getting exhausted; (7) left the house regularly; (8) ate healthy
Time frame: 6 months
Self-Efficacy at 6 Months
Adolescents will be asked the Mental Health Self-efficacy Scale (MHSES) The Mental Health Self-efficacy Scale (Clarke, 2014) measures one's belief in one's capability to perform mental health self-care behaviors. The score ranges from 6 to 60, with higher scores indicating higher confidence in mental health selfcare.
Time frame: 6 months
Social Support at 6 Months
Adolescents will be asked the Medical Outcomes Study Social Support Survey The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. Each item ranges from 1 to 5 and the total score is averaged and ranges from 1 to 5, with higher levels associated with greater support.
Time frame: 6 months
Sleep-Related Impairment at 6 Months
Adolescents will respond to the PROMIS Pediatric Sleep-Related Impairment scale. This scale has four questions with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 19 with higher scores indicating higher levels of sleep-related impairment.
Time frame: 6 months
Sleep Disturbance at 6 Months
Adolescents will respond to the PROMIS Pediatric Sleep Disturbance scale. This scale has four questions, the second (sleeping through the night) being reverse-scored, with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 20 with higher scores indicating higher levels of sleep disturbance.
Time frame: 6 months
Sleep Habits at 3 Months
Adolescents will respond to the School Based Sleep Habits Survey-Child Form which asks 43 questions about weekday and weeknight sleep patterns, sleep awakenings, and sleep time preferences.
Time frame: 3 months
Perceived Need for Service Use at 3 Months
The General-practice Users Perceived-need Inventory (GUPI) The General-Practice Users Perceived-Need Inventory (McNab, 2004) will be used to measure perceived need for treatment. There is no scoring. Adolescents will be asked this and parents about their perception of their adolescent's need for mental health services. The response will be evaluated by the total number of individuals who agree that they would like to or are already getting help with a) medication and b) counseling as comapred to those who respond they do not need this kind of help.
Time frame: 3 months
Perceived Severity at 3 Months
Rating scale of General Mental Health A rating scale of General Mental Health (Cadigan, 2018) will be used with two questions each ranging from 1 to 5 with regard to a self-rating of general mental health. Adolescents will be asked this and parents about their perception of their adolescent's mental health.
Time frame: 3 months
Anxiety Severity at 3 Months
Adolescents will be asked the GAD-7 Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Time frame: 3 months
Parent-Teen Communication Quality at 3 Months
M-PACS (The Parent-Adolescent Communication Scale (Olson, 1985) modified for mental health) asks 20 questions with regards to communication between parents and adolescents, with responses 1-5 from strongly disagree to strongly agree. Some items are reverse scored with a higher scale score indicating better communication. Both adolescents and parents will be asked these questions.
Time frame: 3 months
Parent-Teen Relationship Quality at 3 Months
The CPCS (Child Parent Connectedness Scale) asks 5 questions from a scale of 1-5 from strongly disagree to strongly agree with regards to connectedness and relationship satisfaction with each other. A higher score indicates higher child-parent connectedness. Both adolescents and parents will be asked these questions.
Time frame: 3 months
Suicidal Thoughts
Adolescents who respond with anything besides "none" to the 9th question of the PHQ-9 will be asked to complete the brief CSSR-S scale. This scale asks two questions, have you (the participant) wished you (the participant) were dead or wished you (the participant) could go to sleep and not wake up? (yes/no) and have you (the participant) actually had any thoughts of killing yourself? (yes/no). Positive answers indicate suicidal thinking. These will be asked on an online survey. Those adolescents responding positively will complete a full CSSR-S interview.
Time frame: 3 months
Sleep Habits at 6 Months
Adolescents will respond to the School Based Sleep Habits Survey-Child Form which asks 43 questions about weekday and weeknight sleep patterns, sleep awakenings, and sleep time preferences.
Time frame: 6 months
Perceived Severity at 6 Months
Rating scale of General Mental Health A rating scale of General Mental Health (Cadigan, 2018) will be used with two questions each ranging from 1 to 5 with regard to a self-rating of general mental health. Adolescents will be asked this and parents about their perception of their adolescent's mental health.
Time frame: 6 months
Perceived Need for Service Use at 6 Months
The General-practice Users Perceived-need Inventory (GUPI) The General-Practice Users Perceived-Need Inventory (McNab, 2004) will be used to measure perceived need for treatment. There is no scoring. Adolescents will be asked this and parents about their perception of their adolescent's need for mental health services. The response will be evaluated by the total number of individuals who agree that they would like to or are already getting help with a) medication and b) counseling as comapred to those who respond they do not need this kind of help.
Time frame: 6 months
Acceptability of MoodRing: Heathcare Provider Acceptability
System Usability Questionnaire (Bangor, 2008) asks 11 questions about the usability of a technological intervention. SUS scores range from 0-100. Higher scores indicate better usability.
Time frame: at 6 months
Acceptability of MoodRing as a Clinical Tool: Heathcare Provider Acceptability
Acceptability of Intervention Measure (AIM) (Weiner, 2017) asks 4 questions on a 1-5 Likert scale with completely disagree to completely agree with regards to acceptability of an intervention and 3 questions were added including with regards to efficiency, help taking care of patients, patient benefit from the intervention. Higher scores indicate higher acceptability. Also an open-ended question will be asked about feedback using MoodRing.
Time frame: at 6 months
Acceptability of MoodRing: Adolescent/Parent Acceptability
System Usability Questionnaire (Bangor, 2008) asks 11 questions about the usability of a technological intervention. SUS scores 0-100. Higher scores indicate better usability. Adolescents and Parents - only those randomized to the MoodRing arm - will be asked these questions.
Time frame: at 6 months
Acceptability of MoodRing as a Self-management Tool: Adolescent/Parent Acceptability
Acceptability of Intervention Measure (AIM) (Weiner, 2017) asks 4 questions on a 1-5 Likert scale with completely disagree to completely agree with regards to acceptability of an intervention. Additional questions will be asked about perceived benefit, taking care of mental health, and confidence in mental health management. Higher scores indicate higher acceptability. Also an open-ended question will be asked about feedback using MoodRing. Adolescents and Parents - only those randomized to the MoodRing arm - will be asked these questions.
Time frame: at 6 months
Anxiety Severity at 6 Months
Adolescents will be asked the GAD-7 Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Time frame: 6 months
Parent-Teen Communication Quality at 6 Months
M-PACS (The Parent-Adolescent Communication Scale (Olson, 1985) modified for mental health) asks 20 questions with regards to communication between parents and adolescents, with responses 1-5 from strongly disagree to strongly agree. Some items are reverse scored with a higher scale score indicating better communication. Both adolescents and parents will be asked these questions.
Time frame: 6 months
Parent-Teen Relationship Quality at 6 Months
The CPCS (Child Parent Connectedness Scale) asks 5 questions from a scale of 1-5 from strongly disagree to strongly agree with regards to connectedness and relationship satisfaction with each other. A higher score indicates higher child-parent connectedness. Both adolescents and parents will be asked these questions.
Time frame: 6 months
Suicidal Thoughts
Adolescents who respond with anything besides "none" to the 9th question of the PHQ-9 will be asked to complete the brief CSSR-S scale. This scale asks two questions, have you (the participant) wished you (the participant) were dead or wished you (the participant) could go to sleep and not wake up? (yes/no) and have you (the participant) actually had any thoughts of killing yourself? (yes/no). Positive answers indicate suicidal thinking. These will be asked on an online survey. Those adolescents responding positively will complete a full CSSR-S interview.
Time frame: 6 months
Recruitment sources: 81.4% from social media advertisement (591/726), 9.5% completing an electronic interest form in clinic at UPMC Children's Hospital of Pittsburgh Center for Adolescent and Young Adult Health (69/726), and from 9% completing the University of Pittsburgh online interest form (Pitt+Me) (66/726). Out of these, 12.5% (91/726) were able to be reached to complete screening. Prior to the study a plan was made to enroll healthcare providers. One provider was approached did not enroll.
| Milestone | Usual Care | MoodRing |
|---|---|---|
| Started | 31 | 32 |
| Completed | 12 | 9 |
| Not completed | 19 | 23 |
| Withdrew: Dyads who did not complete 3 month due to parent not completing (only adolescent completed) | 13 | 15 |
| Withdrew: Dyads who did not complete 3 month due to adolescent not completing (only parent completed) | 3 | 3 |
| Withdrew: Lost to follow-up | 3 | 5 |
| Milestone | Usual Care | MoodRing |
|---|---|---|
| Started | 31 | 32 |
| Completed | 8 | 8 |
| Not completed | 23 | 24 |
| Withdrew: Dyads who did not complete 6 month due to parent not completing (only adolescent completed) | 14 | 13 |
| Withdrew: Dyads who did not complete 6 month due to parent not completing (only adolescent completed) | 1 | 5 |
| Withdrew: Lost to follow-up | 8 | 6 |
Adolescents will be asked the Partners in Health Scale The revised Partners in Health Scale (Smith 2016) assesses self-management with respect to a chronic condition, with regard to active involvement of a patient in managing their condition. Total scores range from 0 to 96 with higher scores indicating worse self-management. A larger negative change in self-management score means an improvement in self-management.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Change From Baseline in Self-management at 3 Months | 12 ± 14.3 | -1.84 ± 16.04 |
Attendance at a healthcare provider visit for depression symptom reassessment within 3 months (yes/no) measured by adolescent or parent self-report (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
| Participants | Usual Care | MoodRing |
|---|---|---|
| Quality of Depression Management: Depression Symptom Reassessment | 20 | 24 |
Out of adolescents who are taking an antidepressant, receipt of at least 60 consecutive days (yes/no) measured by adolescent self-report. The metric reported will be percentage of individuals per study arm with a 'yes' result.
| Participants | Usual Care | MoodRing |
|---|---|---|
| Quality of Depression Management: Medication Adherence | 16 | 12 |
Out of adolescents who report being referred for psychotherapy, receipt of at least 3 sessions within 3 months (yes/no) measured by adolescent and parent self-report (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
| Participants | Usual Care | MoodRing |
|---|---|---|
| Quality of Depression Management: Therapy Adherence | 15 | 14 |
Average Number of visits for (greater number as reported by adolescent self-report and parent self-report): 1. urgent care; 2. emergency room; 3. inpatient hospitalization; 4. acute primary care provider visit for non-mental health related concern; 5. medical subspecialist visit 6. surgical subspecialist visit
| average number of visits | Usual Care | MoodRing |
|---|---|---|
| Urgent Care Visits | 0.21 ± 0.53 | 0.20 ± 0.48 |
| Emergency Room | 0.10 ± 0.31 | 0.22 ± 0.54 |
| Inpatient Hospitalization | 0.10 ± 0.39 | 0 ± 0 |
| Acute PCP visit non mental health | 0.52 ± 0.79 | 0.44 ± 0.95 |
| Medical Subspecialist Visit | 0.62 ± 0.94 | 0.37 ± 0.71 |
| Surgical Subspecialist Visit | 0.15 ± 0.46 | 0.15 ± 0.53 |
Adolescents will be asked the PHQ-9 Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Depression Severity at 3 Months | 11.19 ± 3.56 | 11.17 ± 5.14 |
Adolescents will respond to the PROMIS Pediatric Sleep-Related Impairment scale. This scale has four questions with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 19 with higher scores indicating higher levels of sleep-related impairment.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Sleep-Related Impairment at 3 Months | 13.12 ± 3.85 | 13.17 ± 3.81 |
Adolescents will respond to the PROMIS Pediatric Sleep Disturbance scale. This scale has four questions, the second (sleeping through the night) being reverse-scored, with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 20 with higher scores indicating higher levels of sleep disturbance.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Sleep Disturbance at 3 Months | 13.48 ± 2.74 | 13.67 ± 3.67 |
Adolescents will be asked the Mental Health Self-efficacy Scale (MHSES) The Mental Health Self-efficacy Scale (Clarke, 2014) measures one's belief in one's capability to perform mental health self-care behaviors. The score ranges from 6 to 60, with higher scores indicating higher confidence in mental health selfcare.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Self-Efficacy at 3 Months | 33.62 ± 9.43 | 35.72 ± 9.77 |
Adolescents will be asked based on Question 12 of Partners in Health Scale about self-management behavior. This question asks the average amount of time (options including Daily, More than once a week, Once a week, Once a month, Once a semester, Once a year, Less than once a year, Never) spent in potentially useful self-management activities. Each time category will be described by a percentage. Each of the following are asked individually: (1) created to-do lists to help me focus; (2) found strategies to create pleasurable distractions; (3) engaged in some physical activity (cycling, walking, etc.); (4) set realistic short-term goals; (5) made sure I had a good day/night routine with got enough sleep; (6) ensured enough rest to avoid getting exhausted; (7) left the house regularly; (8) ate healthy A higher score indicates a better outcome.
| Participants | Usual Care | MoodRing |
|---|---|---|
| Created to-do lists to help me focus — Daily | 4 | 5 |
| Created to-do lists to help me focus — More than Once a Week | 3 | 3 |
| Created to-do lists to help me focus — Once a Week | 3 | 5 |
| Created to-do lists to help me focus — Once a month | 7 | 0 |
| Created to-do lists to help me focus — Once a semester (3-4 months) | 4 | 3 |
| Created to-do lists to help me focus — Once a year | 1 | 3 |
| Created to-do lists to help me focus — Less than once a year | 4 | 0 |
| Created to-do lists to help me focus — Never | 0 | 6 |
| Found strategies to create pleasurable distractions — Daily | 2 | 5 |
| Found strategies to create pleasurable distractions — More than Once a Week | 7 | 6 |
| Found strategies to create pleasurable distractions — Once a Week | 9 | 3 |
| Found strategies to create pleasurable distractions — Once a month | 3 | 7 |
| Found strategies to create pleasurable distractions — Once a semester (3-4 months) | 3 | 2 |
| Found strategies to create pleasurable distractions — Once a year | 1 | 1 |
| Found strategies to create pleasurable distractions — Less than once a year | 1 | 1 |
| Found strategies to create pleasurable distractions — Never | 0 | 0 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Daily | 2 | 11 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — More than Once a Week | 8 | 1 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Once a Week | 9 | 10 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Once a month | 4 | 2 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Once a semester (3-4 months) | 2 | 1 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Once a year | 0 | 0 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Less than once a year | 1 | 0 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Never | 0 | 0 |
| Set realistic short-term goals — Daily | 2 | 4 |
| Set realistic short-term goals — More than Once a Week | 5 | 3 |
| Set realistic short-term goals — Once a Week | 1 | 7 |
| Set realistic short-term goals — Once a month | 7 | 2 |
| Set realistic short-term goals — Once a semester (3-4 months) | 9 | 2 |
| Set realistic short-term goals — Once a year | 2 | 2 |
| Set realistic short-term goals — Less than once a year | 0 | 2 |
| Set realistic short-term goals — Never | 0 | 3 |
| Made sure I had a good day/night routine and got enough sleep — Daily | 1 | 4 |
| Made sure I had a good day/night routine and got enough sleep — More than Once a Week | 10 | 8 |
| Made sure I had a good day/night routine and got enough sleep — Once a Week | 5 | 6 |
| Made sure I had a good day/night routine and got enough sleep — Once a month | 3 | 2 |
| Made sure I had a good day/night routine and got enough sleep — Once a semester (3-4 months) | 4 | 3 |
| Made sure I had a good day/night routine and got enough sleep — Once a year | 2 | 0 |
| Made sure I had a good day/night routine and got enough sleep — Less than once a year | 0 | 2 |
| Made sure I had a good day/night routine and got enough sleep — Never | 1 | 0 |
| Ensured enough rest to avoid getting exhausted — Daily | 2 | 2 |
| Ensured enough rest to avoid getting exhausted — More than Once a Week | 7 | 8 |
| Ensured enough rest to avoid getting exhausted — Once a Week | 9 | 6 |
| Ensured enough rest to avoid getting exhausted — Once a month | 1 | 5 |
| Ensured enough rest to avoid getting exhausted — Once a semester (3-4 months) | 4 | 1 |
| Ensured enough rest to avoid getting exhausted — Once a year | 2 | 1 |
| Ensured enough rest to avoid getting exhausted — Less than once a year | 0 | 1 |
| Ensured enough rest to avoid getting exhausted — Never | 1 | 1 |
| Left the house regulary — Daily | 5 | 9 |
| Left the house regulary — More than Once a Week | 12 | 10 |
| Left the house regulary — Once a Week | 5 | 2 |
| Left the house regulary — Once a month | 3 | 1 |
| Left the house regulary — Once a semester (3-4 months) | 0 | 0 |
| Left the house regulary — Once a year | 1 | 1 |
| Left the house regulary — Less than once a year | 0 | 1 |
| Left the house regulary — Never | 0 | 1 |
| Ate healthy — Daily | 4 | 3 |
| Ate healthy — More than Once a Week | 14 | 12 |
| Ate healthy — Once a Week | 5 | 4 |
| Ate healthy — Once a month | 1 | 2 |
| Ate healthy — Once a semester (3-4 months) | 0 | 2 |
| Ate healthy — Once a year | 1 | 0 |
| Ate healthy — Less than once a year | 0 | 1 |
| Ate healthy — Never | 1 | 1 |
Adolescents will be asked the Medical Outcomes Study Social Support Survey The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. Each item ranges from 1 to 5 and the total score is averaged and ranges from 1 to 5, with higher levels associated with greater support.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Social Support at 3 Months | 3.66 ± 0.84 | 4.08 ± 0.72 |
Adolescents will be asked the Partners in Health Scale The revised Partners in Health Scale (Smith 2016) assesses self-management with respect to a chronic condition, with regard to active involvement of a patient in managing their condition. Total scores range from 0 to 96 with higher scores indicating worse self-management. A larger negative change in self-management score means an improvement in self-management.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Change in Self-management at 6 Months | -1.55 ± 13.3 | -4.6 ± 16.2 |
Attendance at a healthcare provider visit for depression symptom reassessment within the past 3 months (yes/no) measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
| Participants | Usual Care | MoodRing |
|---|---|---|
| Quality of Depression Management: Depression Symptom Reassessment | 14 | 16 |
Out of adolescents who are taking an antidepressant, receipt of at least 60 consecutive days (yes/no) within the past 3 months, measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
| Participants | Usual Care | MoodRing |
|---|---|---|
| Quality of Depression Management: Medication Adherence | 11 | 11 |
Out of adolescents who are referred for psychotherapy, receipt of at least 3 sessions within the past 3 months (yes/no) measured by adolescent, parent self-report and electronic health record review (yes if any are yes, no if all are no). The metric reported will be percentage of individuals per study arm with a 'yes' result.
| Participants | Usual Care | MoodRing |
|---|---|---|
| Quality of Depression Management: Therapy Adherence | 11 | 17 |
Number of visits for (combined total between adolescent self-report, parent self-report, and electronic health-record review): 1. urgent care; 2. emergency room; 3. inpatient hospitalization; 4. acute primary care provider visit for non-mental health related concern; 5. medical or surgical subspecialist visit
| patient visits | Usual Care | MoodRing |
|---|---|---|
| Urgent Care Visits | 0.22 ± 0.58 | 0.27 ± 0.64 |
| Emergency Room | 0 ± 0 | 0.15 ± 0.43 |
| Inpatient Hospitalization | 0 ± 0 | 0.04 ± 0.20 |
| Acute PCP visit non mental health | 0.30 ± 0.52 | 0.27 ± 0.56 |
| Medical Subspecialist Visit | 0.61 ± 1.19 | 0.94 ± 1.58 |
| Surgical Subspecialist Visit | 0.13 ± 0.43 | 0.15 ± 0.54 |
Adolescents will be asked the PHQ-9 Patient Health Questionnaire-9 measures depression severity with a score ranging from 0 to 27, a higher score indicating greater severity.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Depression Severity at 6 Months | 11.1 ± 4.88 | 8.45 ± 3.75 |
Adolescents will be asked based on Question 12 of Partners in Health Scale about self-management behavior. This question asks the average amount of time (options including Daily, More than once a week, Once a week, Once a month, Once a semester, Once a year, Less than once a year, Never) spent in potentially useful self-management activities. Each of the following are asked individually: (1) created to-do lists to help me focus; (2) found strategies to create pleasurable distractions; (3) engaged in some physical activity (cycling, walking, etc.); (4) set realistic short-term goals; (5) made sure I had a good day/night routine with got enough sleep; (6) ensured enough rest to avoid getting exhausted; (7) left the house regularly; (8) ate healthy
| Participants | Usual Care | MoodRing |
|---|---|---|
| to help me focus — Daily | 3 | 5 |
| to help me focus — More than Once a Week | 2 | 3 |
| to help me focus — Once a Week | 6 | 1 |
| to help me focus — Once a month | 3 | 3 |
| to help me focus — Once a semester (3-4 months) | 3 | 2 |
| to help me focus — Once a year | 0 | 3 |
| to help me focus — Less than once a year | 2 | 2 |
| to help me focus — Never | 1 | 1 |
| Found strategies to create pleasurable distractions — Daily | 3 | 7 |
| Found strategies to create pleasurable distractions — More than Once a Week | 4 | 5 |
| Found strategies to create pleasurable distractions — Once a Week | 7 | 3 |
| Found strategies to create pleasurable distractions — Once a month | 3 | 4 |
| Found strategies to create pleasurable distractions — Once a semester (3-4 months) | 2 | 0 |
| Found strategies to create pleasurable distractions — Once a year | 0 | 1 |
| Found strategies to create pleasurable distractions — Less than once a year | 1 | 0 |
| Found strategies to create pleasurable distractions — Never | 0 | 0 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Daily | 6 | 6 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — More than Once a Week | 5 | 4 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Once a Week | 3 | 7 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Once a month | 5 | 1 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Once a semester (3-4 months) | 1 | 1 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Once a year | 0 | 1 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Less than once a year | 0 | 0 |
| Engaged in some moderate physical activity (cycling, walking, etc.) — Never | 0 | 0 |
| Set realistic short-term goals — Daily | 2 | 5 |
| Set realistic short-term goals — More than Once a Week | 4 | 4 |
| Set realistic short-term goals — Once a Week | 2 | 6 |
| Set realistic short-term goals — Once a month | 4 | 2 |
| Set realistic short-term goals — Once a semester (3-4 months) | 5 | 2 |
| Set realistic short-term goals — Once a year | 2 | 1 |
| Set realistic short-term goals — Less than once a year | 0 | 0 |
| Set realistic short-term goals — Never | 1 | 0 |
| Made sure I had a good day/night routine and got enough sleep — Daily | 2 | 3 |
| Made sure I had a good day/night routine and got enough sleep — More than Once a Week | 3 | 7 |
| Made sure I had a good day/night routine and got enough sleep — Once a Week | 5 | 6 |
| Made sure I had a good day/night routine and got enough sleep — Once a month | 6 | 2 |
| Made sure I had a good day/night routine and got enough sleep — Once a semester (3-4 months) | 3 | 1 |
| Made sure I had a good day/night routine and got enough sleep — Once a year | 0 | 0 |
| Made sure I had a good day/night routine and got enough sleep — Less than once a year | 0 | 0 |
| Made sure I had a good day/night routine and got enough sleep — Never | 1 | 1 |
| Ensured enough rest to avoid getting exhausted — Daily | 3 | 1 |
| Ensured enough rest to avoid getting exhausted — More than Once a Week | 5 | 7 |
| Ensured enough rest to avoid getting exhausted — Once a Week | 2 | 8 |
| Ensured enough rest to avoid getting exhausted — Once a month | 7 | 2 |
| Ensured enough rest to avoid getting exhausted — Once a semester (3-4 months) | 2 | 0 |
| Ensured enough rest to avoid getting exhausted — Once a year | 0 | 1 |
| Ensured enough rest to avoid getting exhausted — Less than once a year | 1 | 0 |
| Ensured enough rest to avoid getting exhausted — Never | 0 | 1 |
| Left the house regularly — Daily | 4 | 10 |
| Left the house regularly — More than Once a Week | 11 | 6 |
| Left the house regularly — Once a Week | 5 | 2 |
| Left the house regularly — Once a month | 0 | 1 |
| Left the house regularly — Once a semester (3-4 months) | 0 | 1 |
| Left the house regularly — Once a year | 0 | 0 |
| Left the house regularly — Less than once a year | 0 | 0 |
| Left the house regularly — Never | 0 | 0 |
| Ate healthy — Daily | 5 | 3 |
| Ate healthy — More than Once a Week | 6 | 9 |
| Ate healthy — Once a Week | 6 | 4 |
| Ate healthy — Once a month | 2 | 1 |
| Ate healthy — Once a semester (3-4 months) | 0 | 2 |
| Ate healthy — Once a year | 1 | 1 |
| Ate healthy — Less than once a year | 0 | 0 |
| Ate healthy — Never | 0 | 0 |
Adolescents will be asked the Mental Health Self-efficacy Scale (MHSES) The Mental Health Self-efficacy Scale (Clarke, 2014) measures one's belief in one's capability to perform mental health self-care behaviors. The score ranges from 6 to 60, with higher scores indicating higher confidence in mental health selfcare.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Self-Efficacy at 6 Months | 37.5 ± 9.32 | 39.95 ± 10.56 |
Adolescents will be asked the Medical Outcomes Study Social Support Survey The Medical Outcome Study Social Support Scale (Sherbourne, 1991) measures types of social support. Each item ranges from 1 to 5 and the total score is averaged and ranges from 1 to 5, with higher levels associated with greater support.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Social Support at 6 Months | 4.03 ± 0.76 | 4.04 ± 0.83 |
Adolescents will respond to the PROMIS Pediatric Sleep-Related Impairment scale. This scale has four questions with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 19 with higher scores indicating higher levels of sleep-related impairment.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Sleep-Related Impairment at 6 Months | 12.9 ± 4.79 | 13.05 ± 3.02 |
Adolescents will respond to the PROMIS Pediatric Sleep Disturbance scale. This scale has four questions, the second (sleeping through the night) being reverse-scored, with response options of never, almost never, sometimes, almost always, and always, ranges from 4 to 20 with higher scores indicating higher levels of sleep disturbance.
| score on a scale | Usual Care | MoodRing |
|---|---|---|
| Sleep Disturbance at 6 Months | 13.1 ± 2.63 | 13.65 ± 2.28 |
Adolescents will respond to the School Based Sleep Habits Survey-Child Form which asks 43 questions about weekday and weeknight sleep patterns, sleep awakenings, and sleep time preferences.
Results for this outcome have not been posted.
The General-practice Users Perceived-need Inventory (GUPI) The General-Practice Users Perceived-Need Inventory (McNab, 2004) will be used to measure perceived need for treatment. There is no scoring. Adolescents will be asked this and parents about their perception of their adolescent's need for mental health services. The response will be evaluated by the total number of individuals who agree that they would like to or are already getting help with a) medication and b) counseling as comapred to those who respond they do not need this kind of help.
Results for this outcome have not been posted.
Rating scale of General Mental Health A rating scale of General Mental Health (Cadigan, 2018) will be used with two questions each ranging from 1 to 5 with regard to a self-rating of general mental health. Adolescents will be asked this and parents about their perception of their adolescent's mental health.
Results for this outcome have not been posted.
Adolescents will be asked the GAD-7 Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Results for this outcome have not been posted.
M-PACS (The Parent-Adolescent Communication Scale (Olson, 1985) modified for mental health) asks 20 questions with regards to communication between parents and adolescents, with responses 1-5 from strongly disagree to strongly agree. Some items are reverse scored with a higher scale score indicating better communication. Both adolescents and parents will be asked these questions.
Results for this outcome have not been posted.
The CPCS (Child Parent Connectedness Scale) asks 5 questions from a scale of 1-5 from strongly disagree to strongly agree with regards to connectedness and relationship satisfaction with each other. A higher score indicates higher child-parent connectedness. Both adolescents and parents will be asked these questions.
Results for this outcome have not been posted.
Adolescents who respond with anything besides "none" to the 9th question of the PHQ-9 will be asked to complete the brief CSSR-S scale. This scale asks two questions, have you (the participant) wished you (the participant) were dead or wished you (the participant) could go to sleep and not wake up? (yes/no) and have you (the participant) actually had any thoughts of killing yourself? (yes/no). Positive answers indicate suicidal thinking. These will be asked on an online survey. Those adolescents responding positively will complete a full CSSR-S interview.
Results for this outcome have not been posted.
Adolescents will respond to the School Based Sleep Habits Survey-Child Form which asks 43 questions about weekday and weeknight sleep patterns, sleep awakenings, and sleep time preferences.
Results for this outcome have not been posted.
Rating scale of General Mental Health A rating scale of General Mental Health (Cadigan, 2018) will be used with two questions each ranging from 1 to 5 with regard to a self-rating of general mental health. Adolescents will be asked this and parents about their perception of their adolescent's mental health.
Results for this outcome have not been posted.
The General-practice Users Perceived-need Inventory (GUPI) The General-Practice Users Perceived-Need Inventory (McNab, 2004) will be used to measure perceived need for treatment. There is no scoring. Adolescents will be asked this and parents about their perception of their adolescent's need for mental health services. The response will be evaluated by the total number of individuals who agree that they would like to or are already getting help with a) medication and b) counseling as comapred to those who respond they do not need this kind of help.
Results for this outcome have not been posted.
System Usability Questionnaire (Bangor, 2008) asks 11 questions about the usability of a technological intervention. SUS scores range from 0-100. Higher scores indicate better usability.
Results for this outcome have not been posted.
Acceptability of Intervention Measure (AIM) (Weiner, 2017) asks 4 questions on a 1-5 Likert scale with completely disagree to completely agree with regards to acceptability of an intervention and 3 questions were added including with regards to efficiency, help taking care of patients, patient benefit from the intervention. Higher scores indicate higher acceptability. Also an open-ended question will be asked about feedback using MoodRing.
Results for this outcome have not been posted.
System Usability Questionnaire (Bangor, 2008) asks 11 questions about the usability of a technological intervention. SUS scores 0-100. Higher scores indicate better usability. Adolescents and Parents - only those randomized to the MoodRing arm - will be asked these questions.
Results for this outcome have not been posted.
Acceptability of Intervention Measure (AIM) (Weiner, 2017) asks 4 questions on a 1-5 Likert scale with completely disagree to completely agree with regards to acceptability of an intervention. Additional questions will be asked about perceived benefit, taking care of mental health, and confidence in mental health management. Higher scores indicate higher acceptability. Also an open-ended question will be asked about feedback using MoodRing. Adolescents and Parents - only those randomized to the MoodRing arm - will be asked these questions.
Results for this outcome have not been posted.
Adolescents will be asked the GAD-7 Generalized Anxiety Disorders 7-item Questionnaire measures extent of anxiety symptoms. The total score ranges from 0 to 21 with a higher score indicating greater severity.
Results for this outcome have not been posted.
M-PACS (The Parent-Adolescent Communication Scale (Olson, 1985) modified for mental health) asks 20 questions with regards to communication between parents and adolescents, with responses 1-5 from strongly disagree to strongly agree. Some items are reverse scored with a higher scale score indicating better communication. Both adolescents and parents will be asked these questions.
Results for this outcome have not been posted.
The CPCS (Child Parent Connectedness Scale) asks 5 questions from a scale of 1-5 from strongly disagree to strongly agree with regards to connectedness and relationship satisfaction with each other. A higher score indicates higher child-parent connectedness. Both adolescents and parents will be asked these questions.
Results for this outcome have not been posted.
Adolescents who respond with anything besides "none" to the 9th question of the PHQ-9 will be asked to complete the brief CSSR-S scale. This scale asks two questions, have you (the participant) wished you (the participant) were dead or wished you (the participant) could go to sleep and not wake up? (yes/no) and have you (the participant) actually had any thoughts of killing yourself? (yes/no). Positive answers indicate suicidal thinking. These will be asked on an online survey. Those adolescents responding positively will complete a full CSSR-S interview.
Results for this outcome have not been posted.
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care | 0/62 (0%) | 0/62 (0%) | 0/62 (0%) |
| MoodRing | 0/64 (0%) | 0/64 (0%) | 0/64 (0%) |
For age: Adolescents and Parents are reported separately because providing a total average age across adolescents and parents is not indicated.
| Age, Continuous(years) | MoodRing - Adolescents | MoodRing - Parents | Usual Care - Adolescents | Usual Care - Parents | Total |
|---|---|---|---|---|---|
| Adolescents | 16.25 ± 1.41 | — | 15.65 ± 1.45 | — | 15.95 ± 1.43 |
| Parents | — | 45.12 ± 6.8 | — | 47.16 ± 7.08 | 46.12 ± 6.94 |
| Sex/Gender, Customized(Participants) | MoodRing - Adolescents | MoodRing - Parents | Usual Care - Adolescents | Usual Care - Parents | Total |
|---|---|---|---|---|---|
| Boy/Man | 8 | 2 | 10 | 0 | 20 |
| Girl/Woman | 18 | 30 | 19 | 31 | 98 |
| Not applicable | 6 | 0 | 2 | 0 | 8 |
| Ethnicity (NIH/OMB)(Participants) | MoodRing - Adolescents | MoodRing - Parents | Usual Care - Adolescents | Usual Care - Parents | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 2 | 0 | 4 | 2 | 8 |
| Not Hispanic or Latino | 30 | 32 | 27 | 29 | 118 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | MoodRing - Adolescents | MoodRing - Parents | Usual Care - Adolescents | Usual Care - Parents | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 | 0 |
| Asian | 3 | 3 | 1 | 0 | 7 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 1 | 0 | 1 |
| Black or African American | 3 | 3 | 2 | 3 | 11 |
| White | 23 | 26 | 23 | 26 | 98 |
| More than one race | 3 | 0 | 4 | 2 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Self-Management(units on a scale) | MoodRing - Adolescents | MoodRing - Parents | Usual Care - Adolescents | Usual Care - Parents | Total |
|---|---|---|---|---|---|
| Mean | 60.72 ± 18.14 | — | 59.74 ± 13.51 | — | 60.24 ± 15.91 |
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