Developing Resilience and Anxiety Management Through the Arts

NCT ID: NCT07033052

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2027-07-01

Brief Summary

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.

Detailed Description

The purpose of this study is to observe the benefits of theatrical improvisation exercises paired with cognitive-behavioral therapy (CBT) techniques versus improvisation exercises alone versus a craft control group on reducing elevated levels of anxiety and depression in children and adolescents. It is possible that improvisational techniques could reduce anxiety and depression symptoms because they involve being spontaneous and going into social situations as well as creating something larger than oneself through the group (e.g., creating a scene, working together, etc.). It is also possible that the addition of CBT techniques might lead to a further reduction in anxiety and depression. The study will compare these to a control craft group where youth work on craft projects. The researchers hypothesize that improvisation exercises paired with CBT techniques will be more effective at reducing anxiety and depression than improvisational exercises alone, which we expect will be more effective than a craft group. This improvisation course will not be implemented by licensed therapists or psychologists. Group leaders will be undergraduates, schoolteachers, and graduate students without a background in therapy or counseling (e.g., drama students, music students, etc.) As such, it is important to note that this should not be considered "therapy" or an "intervention." It should not replace intensive treatment for children or adolescents who require a higher level of treatment. Rather, it can be considered a supplementary or preventative group that can help children or adolescents manage feelings of anxiety or depression. The goal of the study is to reduce existing levels of anxiety and depression, prevent the development of new symptoms, and prevent exacerbation of symptoms.

Conditions

Anxiety; Depression; Mood

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Improvisation + Wellness

The Improvisation + Wellness arm will include a variety of techniques based on Cognitive Behavioral Therapy (CBT): behavior activation, mindfulness, relaxation techniques, exposure, and cognitive restructuring. The improvisation techniques will include using your truth (talk about what you know), making patterns (working with others in the group to create something that you all contribute to), yes…and (agreeing with others and building on what others contribute to activities/conversations).

Group Type: EXPERIMENTAL

Improvisation + Wellness

Intervention Type: BEHAVIORAL

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

Improvisation

The improvisation alone arm involves the same improv techniques as the improv + wellness arm, but without the wellness techniques. Improv techniques include using your truth (talk about what you know), making patterns (working with others in the group to create something that you all contribute to), yes…and (agreeing with others and building on what others contribute to activities/conversations).

Group Type: EXPERIMENTAL

Improvisation

Intervention Type: BEHAVIORAL

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.

Social Craft

The social craft group involves youth connecting with other youth while completing craft projects.

Group Type: ACTIVE_COMPARATOR

Social Craft

Intervention Type: BEHAVIORAL

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

Interventions

Improvisation + Wellness

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Social Craft

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Between 8 and 17 years of age
• Individuals must have parental/guardian consent
• Elevated levels of anxiety or depression based on

1. Screen for Child Anxiety Related Disorders (SCARED) score of 15 or higher, or;

2. Revised Children's Anxiety and Depression Scale (RCADS) Depression T score of 65 or higher, or;

3. 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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Expanding Horizons Initiative

UNKNOWN

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Przeworski, PhD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Case Western Reserve University

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Amy Przeworski, PhD

Role: CONTACT

axp335@case.edu

216-368-5021

Facility Contacts

Amy Przeworski, PhD

Role: primary

soarlab@case.edu

216-368-5022

Other Identifiers

NEA AWARD 1891861-38-22

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY20241298

Identifier Type: -

Identifier Source: org_study_id