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| ID | Type | Description | Link |
|---|---|---|---|
| R44AT013552 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| Boston College | OTHER |
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The goal of this clinical trial is to learn if a personalized arts-based social prescribing program, Art Pharmacy, delivered through a mobile app (SocialRx App) can improve mental health and social connectedness in adolescents aged 15-18 with depression or anxiety enrolled in Medicaid managed care.
The main question it aims to answer is:
Compared to stable treatment, does participation in the Art Pharmacy program through the SocialRx App improve depression, anxiety, social connectedness, and loneliness? Researchers will compare participants receiving the Art Pharmacy program and digital companion to those receiving stable treatment (no change to existing care) to evaluate its effects on mental health and social connectedness.
Participants will:
Be randomly assigned to either the Art Pharmacy program delivered through the SocialRx App or a control group receiving stable treatment.
Complete online surveys at baseline and follow-up time points (e.g., 3, 6, 9, and 12 months).
If assigned to the intervention group, Art Pharmacy, participants will receive monthly arts and cultural activity recommendations, attend activities, and interact with a care navigator delivered through the SocialRx App.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Art Pharmacy program delivered through the SocialRx App | Experimental | A personalized arts-based social prescribing program, Art Pharmacy, delivered through a mobile app, SocialRx App |
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| Stable treatment | Active Comparator | Existing, stable treatment regimen without major changes |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Art Pharmacy | Behavioral | A personalized arts-based social prescribing program |
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| Measure | Description | Time Frame |
|---|---|---|
| Anxiety - Generalized Anxiety Disorder-7 (GAD-7) | The GAD-7 is a 7-item self-report measure of anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater anxiety severity. | At baseline, and 3-, 6-, 9- and 12-month follow up. |
| Depression - Patient Health Questionnaire-9 Adolescent Version (PHQ-9A) | The PHQ-9A is a 9-item self-report measure of depressive symptoms in adolescents. Scores range from 0 to 27, with higher scores indicating greater depression severity. | At baseline, and 3-, 6-, 9- and 12-month follow up. |
| Loneliness - UCLA Loneliness Scale | The UCLA Loneliness Scale assesses subjective feelings of loneliness and social isolation. Scores range from 20 - 80, with higher scores indicating a higher degree of loneliness. | At baseline, and 3-, 6-, 9-, and 12-month follow up |
| Social Connectedness - Social Connectedness Scale-Revised (SCS-R) | The SCS-R measures feelings of interpersonal closeness and connectedness. Scores range from 20 to 120, with higher scores indicating greater social connectedness. | At baseline, and 3-, 6-, 9-, and 12-month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Utilization - Treatment and Arts/Cultural Engagement Utilization Questionnaire | A study-developed questionnaire assessing participant engagement with behavioral health treatment and arts/cultural activities. Higher scores/frequencies indicate greater utilization and engagement. | At baseline, and 3-, 6-, 9-, and 12-month follow up |
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Inclusion Criteria:
Participants must meet the following criteria:
Exclusion Criteria:
Participants will be excluded if they:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Research & Evaluation Manager | Contact | 845-807-8005 | peter@socialrx.com |
| Name | Affiliation | Role |
|---|---|---|
| Dawn McDaniel, PhD | SocialRx Inc | Principal Investigator |
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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 | May 13, 2026 | May 13, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Stable treatment | Other | Stable treatment (no change to existing care) through Medicaid managed care |
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