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.
調査の概要
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Peter Research & Evaluation Manager
- 電話番号：845-807-8005
- メール：peter@socialrx.com
参加基準
適格基準
就学可能な年齢
- 子
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：ダブル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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
|
|
アクティブコンパレータ：Stable treatment
Existing, stable treatment regimen without major changes
|
Stable treatment (no change to existing care) through Medicaid managed care
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Anxiety - Generalized Anxiety Disorder-7 (GAD-7)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Treatment Utilization - Treatment and Arts/Cultural Engagement Utilization Questionnaire
時間枠：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
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Dawn McDaniel, PhD、SocialRx Inc
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。