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NCT07033052 · Case Western Reserve University

Developing Resilience and Anxiety Management Through the Arts

(DRAMA)

What this study is about

The Developing Resilience and Anxiety Management Through the Arts (DRAMA) Study examines the degree to which the arts can help to address stress, anxiety, and sad mood in children and adolescents.

View original scientific description

The Developing Resilience and Anxiety Management Through the Arts (DRAMA) Study examines the degree to which the arts can help to address stress, anxiety, and sad mood in children and adolescents. The researchers will pair theatrical improvisation exercises with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a social craft group on reducing elevated levels of anxiety and depression.

Interventions

BEHAVIORAL

Improvisation + Wellness

Theatrical improvisation exercises, the theatrical art of performance and storytelling without a script, will be combined with wellness techniques

BEHAVIORAL

Improvisation

Theatrical improvisation exercises (the theatrical art of performance and storytelling without a script) will be completed in this arm. These exercises will be fairly similar to that from the improvisation + wellness but without the wellness techniques.

BEHAVIORAL

Social Craft

Participants assigned to the Social Craft group will engage in arts and crafts projects and activities

Primary outcome measures

Child Anxiety and Depression (based on Parent Report)

Time frame: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group

Child anxiety and depression will be measured using a parent-report. The Revised Child Anxiety and Depression Scale Parent Report (RCADS-P) is a 47-item measure that assesses parent-report of child anxiety and depressive symptoms. Parents respond to each item on a 4-point Likert-scale from 0 ("never") to 3 ("always). The measure yields 6 subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). There is also a total anxiety scale, which is the sum of the 5 anxiety subscales and a total internalizing scale, which is the sum of all 6 subscales. The RCADS-P has excellent psychometric properties, including high internal consistency and convergent validity. Higher scores indicate higher anxiety/depression symptoms. A T-score is created based on the child's age and gender.

Child Anxiety and Depression (based on youth report)

Time frame: Baseline, post (after 9 weeks of the group curriculum), and 3 months post-group

Child anxiety and depression will also be measured using a youth report. The Revised Child Anxiety and Depression Scale (RCADS) is a 47 item measure that assesses child report of child anxiety and depressive symptoms. Youth respond to each item on a 4-point Likert-scale from 0 ("never") to 3 ("always). The measure yields 6 subscales including: separation anxiety disorder (SAD), social phobia (SP), generalized anxiety disorder (GAD), panic disorder (PD), obsessive compulsive disorder (OCD), and major depressive disorder (MDD). There is also a total anxiety scale, which is the sum of the 5 anxiety subscales and a total internalizing scale, which is the sum of all 6 subscales. The RCADS has been translated from English into Spanish, Chinese, Dutch, and Danish. The measure has good discriminant validity, internal consistency, and convergent validity and discriminates between anxiety and depression.

Cognitive Behavioral Technique (CBT) Skill Knowledge

Time frame: Baseline, after 9 weeks of the group curriculum, and 3 months post-group

This is a measure designed by the research team that assesses cognitive-behavioral techniques (CBT) Skills knowledge. Participants indicate whether each item is true or false. Items ask about whether thoughts and feelings influence one another, whether avoidance is a good idea when one is anxious about something, present-moment focus/mindfulness, diaphragmatic breathing, activity scheduling, progressive muscle relaxation, etc.

Cognitive Behavioral Technique (CBT) Skills Use

Time frame: Baseline, after 9 weeks of the group curriculum, and 3 months post-group

This is a measure designed by the research team that assesses cognitive-behavioral technique (CBT) Skills use. Participants indicate how often they use each skill on a scale from Never (0) to At least once a day (5). Skills assessed included diaphragmatic breathing, cognitive restructuring, facing your fears, muscle relaxation, being mindful, scheduling pleasant activities, etc.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Between 8 and 17 years of age
  • Individuals must have parental/guardian consent
  • Elevated levels of anxiety or depression based on
  • Screen for Child Anxiety Related Disorders (SCARED) score of 15 or higher, or;
  • Revised Children's Anxiety and Depression Scale (RCADS) Depression T score of 65 or higher, or;
  • Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS) clinician severity rating of 3 on any anxiety disorder or on a mood-related disorder

Exclusion criteria

  • Diagnosed with Conduct Disorder or with behavioral symptoms that would make it difficult for the child/adolescent to participate in the group or comply with directions given by the group leader (such as difficulty following instructions, difficulty staying in one's seat, defiance of adults, harming animals or people, threatening others, getting into physical fights, hyperactivity, impulsivity, difficulty waiting for one's turn, etc.)
  • Autism or developmental delays
  • Psychotic symptoms or active suicidality
  • Active Eating Disorders that raise concerns about morbidity and therefore need to be addressed in an intervention and actively monitored
  • Unsteady dosage or recently or impending changes to psychotropic medication(s)
  • Non-English-speaking individuals
  • Wards of the State

Where

  • Cleveland, Ohio

Collaborators

Expanding Horizons Initiative

Related conditions & keywords

AnxietyDepressionMood

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Jul 20, 2025 · Source of record for eligibility and locations

📊
1 of 110 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Cleveland

Ohio

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Anxiety Treatment in Cleveland?

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Anxiety Treatment Options in Cleveland, Ohio

If you're searching for Anxiety treatment in Cleveland, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Cleveland and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Anxiety. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Ohio
Now Enrolling
Up to 110 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Anxiety?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Anxiety

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Anxiety Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT07033052. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.