Developing Resilience and Anxiety Management Through the Arts (DRAMA) 2
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Child Anxiety and Depression (based on Parent Report)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
Assessors will be blind to participant condition in order to reduce assessor bias.
入排标准
- 年龄范围
- 8 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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).
干预措施: Improvisation + Wellness (Behavioral)
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).
干预措施: Improvisation (Behavioral)
Social Craft
The social craft group involves youth connecting with other youth while completing craft projects.
干预措施: Social Craft (Behavioral)
结局指标
主要结局
Child Anxiety and Depression (based on Parent Report)
时间窗: 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)
时间窗: 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.
Child Anxiety and Depression (based on Parent Report)
时间窗: 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)
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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)
- 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)