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| Name | Class |
|---|---|
| Children's Hospital Los Angeles | OTHER |
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The primary aim of this pilot study is to assess the feasibility, acceptability, and preliminary evidence of efficacy of a self-guided, cognitive behavioral therapy (CBT)-based mobile app intervention (SparkRx) for symptoms of depression among adolescents being treated in specialty medical care settings at Children's Hospital of Los Angeles (CHLA).
Self-report assessments will be collected at pre, post and 1-month follow up time points. Weekly PHQ-8 assessments will also be collected during the 5-week intervention as well as at pre, post and 1- month follow up time points.
Study aims involve evaluating:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SparkRx Mobile App | Other | The 5-week SparkRx app is divided into 5 levels intended to be completed weekly. A character called 'Limbot' is used as a guide. Limbot encourages the user in completing the behavioral activation program and provides personal examples of how they have undertaken behavioral activation therapy. Participants are instructed to complete a weekly Patient Health Questionnaire (PHQ)-8 assessment and Participant Symptom Check (PSC) questionnaire in the mobile app. Tasks in the mobile app progress in a linear fashion-- i.e., each task must be completed to progress to the next task. Certain on-demand resources can be accessed in the app at any time, including crisis resources. Text entries that match a database of concerning words/phrases will trigger an automated pop-up suggesting participants visit the in-app crisis resources if they need additional support. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SparkRx Mobile App | Device | The SparkRx app will be fully self-guided and completed by participants at home. It is designed to be completed over 5 weeks but users may progress through the app at their own pace. The app progresses linearly, i.e., a task must be completed before a participant can progress to the next task. Content for a given week is not expected to take more than 60 minutes to complete. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of intervention - Eligibility | Percent of potential participants eligible to participate | Screening |
| Feasibility of intervention - Participant willingness | Percent of eligible participants willing to participate | Screening |
| Feasibility of intervention - Adherence | Adherence to program: percent of enrolled participants completing all modules by post-treatment | 5 weeks |
| Participant satisfaction with the SparkRx app | Acceptability of intervention. Measured by the User Experience (UXR) questionnaire. Includes questions from the UMUX-Lite; a two-item questionnaire that assesses the usability of the mobile application. Questions have seven response options from Strongly agree to Strongly disagree. Includes questions from the HaTs questionnaire; an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback. | 5 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in depressive symptoms | Measured by the Patient Health Questionnaire (PHQ-8). Score range of 0 to 24 with higher scores indicating worse outcome.
| Change from screening to post-intervention (5 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Health care utilization | Measured by the Healthcare Utilization Questionnaire. A two-item questionnaire that asks whether participants' have used healthcare resources in the past week. | 5 weeks |
| Treatment related changes by physical symptom severity |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aarthi Padmanabhan, PhD | Limbix Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Limbix Health Inc. | San Francisco | California | 94104 | United States |
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| Change in participant-reported health-related quality of life | Measured by the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).A 15-item self-administered questionnaire that captures life satisfaction over the past week. Score range of 14 to 84 with a higher score indicating better outcome. | Change from screening to post-intervention (5 weeks) |
| Change in legal-guardian reported health-related quality of life | Measured by the Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q).A 15-item self-administered questionnaire that captures life satisfaction over the past week. Score range of 14 to 84 with a higher score indicating better outcome. | Change from screening to post-intervention (5 weeks) |
| Change in participant-rated anxiety symptoms | Measured by the Generalized Anxiety Disorder scale (GAD-7).The GAD-7 is a brief 7-item assessment for generalized anxiety disorder with satisfactory sensitivity and specificity. Score range of 0 to 21 with a higher score indicating worse outcome. | Change from screening to post-intervention (5 weeks) |
| Change in legal guardian-reported depressive symptoms | Measured by the Patient Health Questionnaire (PHQ-8). Score range of 0 to 24 with higher scores indicating worse outcome.
| Change from screening to post-intervention (5 weeks) |
| Average treatment related usability rating | Measured by the System Usability Scale (SUS). The SUS consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree. Score range of 0 to 100 with a higher score indicating a better outcome. | 5 weeks |
| Average treatment related engagement rating | Measured by the User Engagement Scale (UES-SF).A statistically reliable measure of self-reported user engagement. The form has 12 items and uses a 5 point Likert scale. Score range of 1-5 with a higher score indicating a better outcome. | 5 weeks |
| Average treatment related program adherence | Measured by mobile app analytics | 5 weeks |
| Average treatment related program engagement | Measured by mobile app analytics | 5 weeks |
Measured by the Functional Disability Inventory a fifteen-item questionnaire that measures functional disability and evaluates the impact of illness on the respondents' physical and psychosocial functioning in everyday social roles. Each question is rated on a 5-point scale from 0(No Trouble) to 4 (Impossible). Score range is 0 to 60 with higher scores indicating a worse outcome.
| 5 weeks |
| Treatment related perceptions of participants' experiences in general with SparkRx | Measured by the User Experience (UXR) questionnaire. Includes questions from the Usability Metric for User Experience-Lite; a two-item questionnaire that assesses the usability of the mobile application. Questions have seven response options from Strongly agree to Strongly disagree. Includes questions from the Happiness Tracking Surveys; an open-ended questionnaire that assesses respondents' experiences with the product and provides options for feedback. | 5 weeks |
| Caregiver burden | Measured by the work absenteeism questionnaire, containing qualitative and quantitative questions about caregiving responsibilities and related impacts on employment. Higher scores are equal to more time missed from work. | 5 weeks |
| ID | Term |
|---|---|
| D003863 | Depression |
| D003865 | Depressive Disorder, Major |
| D005767 | Gastrointestinal Diseases |
| D003866 | Depressive Disorder |
| D000294 | Adolescent Behavior |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D004066 | Digestive System Diseases |
| D010549 | Personal Satisfaction |
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