- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07593443
Application for Arts-Based Social Prescribing
Member Engagement Application for Personalized Arts-based Social Prescriptions
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Peter Research & Evaluation Manager
- Phone Number: 845-807-8005
- Email: peter@socialrx.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Participants must meet the following criteria:
- Aged 15-18 years enrolled in Medicaid managed care
- Positive screen for depression and/or anxiety (e.g., PHQ-2 or GAD-2 ≥ 3)
- Currently own and easily operate a smartphone
- Have a valid e-mail address checked regularly
- English fluency, and
- Have a stable treatment regimen for at least 30 days prior to baseline with no planned treatment changes.
Exclusion Criteria:
Participants will be excluded if they:
- Endorse current suicidal ideation at study screening, defined as a response ≥ 1 ("several days") on Item 9 of the PHQ-9A
- Initiate a new treatment regimen or plan on initiating a new treatment regimen (i.e., medication, psychotherapy, or mind-body interventions) at the time of enrollment.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Art Pharmacy program delivered through the SocialRx App
A personalized arts-based social prescribing program, Art Pharmacy, delivered through a mobile app, SocialRx App
|
A personalized arts-based social prescribing program
|
|
Active Comparator: Stable treatment
Existing, stable treatment regimen without major changes
|
Stable treatment (no change to existing care) through Medicaid managed care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety - Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: At baseline, and 3-, 6-, 9- and 12-month follow up.
|
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)
Time Frame: At baseline, and 3-, 6-, 9- and 12-month follow up.
|
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
Time Frame: At baseline, and 3-, 6-, 9-, and 12-month follow up
|
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)
Time Frame: At baseline, and 3-, 6-, 9-, and 12-month follow up
|
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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Treatment Utilization - Treatment and Arts/Cultural Engagement Utilization Questionnaire
Time Frame: At baseline, and 3-, 6-, 9-, and 12-month follow up
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dawn McDaniel, PhD, SocialRx Inc
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 26.0599
- R44AT013552 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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