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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Peter Research & Evaluation Manager
- Telefonnummer: 845-807-8005
- E-post: peter@socialrx.com
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Aktiv komparator: Stable treatment
Existing, stable treatment regimen without major changes
|
Stable treatment (no change to existing care) through Medicaid managed care
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Anxiety - Generalized Anxiety Disorder-7 (GAD-7)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Treatment Utilization - Treatment and Arts/Cultural Engagement Utilization Questionnaire
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Dawn McDaniel, PhD, SocialRx Inc
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 26.0599
- R44AT013552 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
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