Developing Resilience and Anxiety Management Through the Arts

NCT07033052 | Recruiting

• 2 other identifiers: STUDY20241298NEA AWARD 1891861-38-22
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Depression; Mood

Outcome Measures

Primary Outcomes (4)

• Child Anxiety and Depression (based on Parent Report)

  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.

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

• Child Anxiety and Depression (based on youth report)

  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.

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

• Cognitive Behavioral Technique (CBT) Skill Knowledge

  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.

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

• Cognitive Behavioral Technique (CBT) Skills Use

  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.

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

Secondary Outcomes (4)

• Youth mindfulness

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

• Connectedness

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

• Emotion regulation

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

• Self-esteem

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

Study Arms (3)

Improvisation + Wellness

EXPERIMENTAL

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).

Behavioral: Improvisation + Wellness

Improvisation

EXPERIMENTAL

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).

Behavioral: Improvisation

Social Craft

ACTIVE COMPARATOR

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

Behavioral: Social Craft

Interventions

Improvisation + Wellness BEHAVIORAL

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

Improvisation + Wellness

Improvisation 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.

Improvisation

Social Craft BEHAVIORAL

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

Social Craft

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• Expanding Horizons Initiative: collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Interventions

Health

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Population Characteristics

Study Officials

• Amy Przeworski, PhD

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy Przeworski, PhD

CONTACT

216-368-5021; axp335@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to participant condition in order to reduce assessor bias.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: June 24, 2025
• Study Start: April 15, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 20, 2025

Record last verified: 2025-07

Locations

US (1)