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| ID | Type | Description | Link |
|---|---|---|---|
| R44MH122067 | U.S. NIH Grant/Contract | View source |
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The study was terminated prior to being able to recruit the full sample due to lack of funding and expiration of time on the award. The sample recruited completed the entire 6 month study.
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| Name | Class |
|---|---|
| NuRelm, Inc. | INDUSTRY |
| National Institute of Mental Health (NIMH) | NIH |
| University of Virginia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | Active Comparator | 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. |
|
| MoodRing | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MoodRing App | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months |
| Perceived Need for Service Use at 3 Months |
Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Sam Shaaban, BSEE, MBA | NuRelm, Inc. | Principal Investigator |
| Ana Radovic, MD, MSc | University of Pittsburgh | Principal Investigator |
| Afsaneh Doryab, Ph.D. CS | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Adolescent and Young Adult Health | Pittsburgh | Pennsylvania | 15213 | United States |
Trial outcome data can be accessed by contacting the study principal investigator. Otherwise there is currently no formal plan for data sharing.
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Both the adolescent and the parent were required to complete the baseline survey to enter the study. Out of 73 adolescent and parent dyads consented for the study, 68 (93.1%) of adolescents completed the baseline survey while, despite multiple contacts, only 63 (86.3%) of parents completed the baseline. Therefore 63 adolescent parent dyads were able to start the study and were randomized.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | 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. Usual Care: 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. |
| FG001 | MoodRing | 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. 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Month Timepoint Data Collection |
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| |||||||||||||||||||||
| 6 Month Timepoint Data Collection |
|
For age: Adolescents and Parents are reported separately because providing a total average age across adolescents and parents is not indicated.
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| ID | Title | Description |
|---|---|---|
| BG000 | MoodRing - Adolescents | 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. MoodRing App: Adolescents 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 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | When calculating average adolescent age, 0 parent participants were analyzed. When calculating average parent age, 0 adolescent participants were analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The pre-specified statistical analysis was not scientifically appropriate due to insufficient enrollment. | Posted | Mean | Standard Deviation | score on a scale | From baseline to 3 months |
|
6 months
This study was minimal risk. We did not actively assess for adverse events but had a plan to address if they were to spontaneously occur or be brought up by study participants. We monitored suicidality at 3 and 6 month time points and this was not assessed as an adverse event due to it being a part of the mental illness for some of the adolescents with depression in this trial.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | 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. Usual Care: 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. |
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The pre-specified statistical analysis plan was not performed as it was not scientifically appropriate due to insufficient enrollment. Due to the complexity of intervention development and the COVID-19 pandemic we were not able to complete our enrollment goals prior to funding ceasing.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ana Radovic | University of Pittsburgh | 4126927227 | anr94@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 14, 2022 | Mar 18, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 2, 2023 | May 3, 2024 | ICF_000.pdf |
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This study will use a parallel study design, where participants are randomized into two intervention groups (Usual Care or MoodRing) and will receive interventions in parallel.
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Outcomes assessors will be masked to the intervention condition at follow-up assessment time points.
|
| Usual Care | Other | 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. |
|
| 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. | 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. | 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):
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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):
| 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. | 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 | 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. | 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. | 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. | 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. | 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. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 6 months |
| Lost to Follow-up |
|
| NOT COMPLETED |
|
|
| BG001 | MoodRing - Parents | 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. The MR app provides the parent a notification to view a weekly report predicting their mood score (i.e. depression severity level similar to the Patient health questionnaire-9). |
| BG002 | Usual Care - Adolescents | 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. Usual Care: Adolescents 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. |
| BG003 | Usual Care - Parents | Parents will not receive an intervention but only complete data collection. |
| BG004 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Self-Management | 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. | parents were not asked this measure | Mean | Standard Deviation | units on a scale |
|
| OG001 | MoodRing | 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. 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. |
|
|
| Secondary | 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. | Number participants include Adolescents who did not respond to the question on their baseline survey but their Parents did - total number of responses measured by adolescent or parent self-report even if one was missing. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | 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. | Number analyzed are adolescents who either themselves or their parent indicate taking/being prescribed an antidepressant. | Posted | Count of Participants | Participants | 3 months |
|
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| Secondary | 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. | Number analyzed were adolescents who either themselves or had their parent indicate that they were referred for psychotherapy. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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):
| Number participants include Adolescents who did not respond to the question on their baseline survey but their Parents did - total number of responses measured by adolescent or parent self-report even if one was missing. | Posted | Mean | Standard Deviation | average number of visits | 3 month |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Secondary | 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. | Posted | Count of Participants | Participants | 3 months |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 3 months |
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| Secondary | 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. | Only participants completing this measure were analyzed | Posted | Mean | Standard Deviation | score on a scale | From baseline to 6 months |
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| Secondary | 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. | Number participants include Adolescents who did not respond to the question on their baseline survey but their Parents did - total number of responses measured by adolescent or parent self-report even if one was missing. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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. | Number analyzed were adolescents who either themselves or had their parent indicate that they are taking/prescribed an antidepressant. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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. | Number analyzed were adolescents who either themselves or had their parent indicate that they were referred for psychotherapy. | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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):
| Number participants include Adolescents who did not respond to the question on their baseline survey but their Parents did - total number of responses measured by adolescent or parent self-report even if one was missing. | Posted | Mean | Standard Deviation | patient visits | 6 month |
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| Secondary | 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. | Adolescents | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | 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 | Adolescents | Posted | Count of Participants | Participants | 6 months |
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| Secondary | 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. | Adolescents | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | 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. | Adolescents | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | 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. | Adolescents | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Secondary | 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. | Adolescent | Posted | Mean | Standard Deviation | score on a scale | 6 months |
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| Other Pre-specified | 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. | Not Posted | 3 months | Participants |
| Other Pre-specified | 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. | Not Posted | 3 months | Participants |
| Other Pre-specified | 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. | Not Posted | 3 months | Participants |
| Other Pre-specified | 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. | Not Posted | 3 months | Participants |
| Other Pre-specified | 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. | Not Posted | 3 months | Participants |
| Other Pre-specified | 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. | Not Posted | 3 months | Participants |
| Other Pre-specified | 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. | Not Posted | 3 months | Participants |
| Other Pre-specified | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | at 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | at 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | at 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | at 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | 6 months | Participants |
| Other Pre-specified | 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. | Not Posted | 6 months | Participants |
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| 62 |
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | MoodRing | 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. 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. | 0 | 64 | 0 | 64 | 0 | 64 |
Not provided
Not provided
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Inpatient Hospitalization |
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| Acute PCP visit non mental health |
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| Medical Subspecialist Visit |
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| Surgical Subspecialist Visit |
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| Once a Week |
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| Once a month |
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| Once a semester (3-4 months) |
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| Once a year |
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| Less than once a year |
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| Never |
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| Found strategies to create pleasurable distractions |
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| Engaged in some moderate physical activity (cycling, walking, etc.) |
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| Set realistic short-term goals |
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| Made sure I had a good day/night routine and got enough sleep |
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| Ensured enough rest to avoid getting exhausted |
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| Left the house regulary |
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| Ate healthy |
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| Inpatient Hospitalization |
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| Acute PCP visit non mental health |
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| Medical Subspecialist Visit |
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| Surgical Subspecialist Visit |
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| Once a Week |
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| Once a month |
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| Once a semester (3-4 months) |
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| Once a year |
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| Less than once a year |
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| Never |
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| Found strategies to create pleasurable distractions |
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| Engaged in some moderate physical activity (cycling, walking, etc.) |
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| Set realistic short-term goals |
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| Made sure I had a good day/night routine and got enough sleep |
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| Ensured enough rest to avoid getting exhausted |
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| Left the house regularly |
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| Ate healthy |
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