Theatre in Adolescents With Chronic Medical Conditions (CMCs)

Study Overview
=================
Brief Summary
-----------------
Investigators are building a program that uses improvisation to teach kids and teens with medical issues healthy ways to cope. Medical issues have been linked to anxiety and depression. Doing theatre can prevent these complications. Participants will meet in groups of about ten for ten weeks to do improvisation that is fun and supportive. Participants will meet with a study team member before the program starts, after the program ends, six months after the program ends, and twelve months after the program ends. At these visits, participants will be screened for anxiety, depression, quality of life, and will be given a short interview.

Detailed Description
-----------------
Adolescents with chronic medical conditions are at increased risk for anxiety and depression compared to other people their age. Therapies that use role-play prevent anxiety and depression. However, often these studies do not have an underlying psychological framework, or there is not enough information to replicate the program. Investigators designed an intervention using role-play based on Integrative Community Therapy, developed in the 1980s by Dr. Adalberto Barreto. This program will help adolescents with chronic medical conditions explore their feelings about issues related to having a chronic condition, learn new coping strategies, and help one another find support among peers. This treatment will take place once a week for 10 weeks and investigators will compare the effects to those derived from improvisational theatre alone. To evaluate this new treatment, the study team will screen participants for anxiety, depression, quality of life, and will give a short qualitative interview. This will occur before and after the intervention, 6 months after the intervention, and 1 year after the intervention.

Official Title
-----------------
Evaluating the Use of Theatre to Decrease Depression and Anxiety Among Adolescents With Chronic Medical Conditions (CMCs)

Conditions
-----------------
Chronic Disease

Intervention / Treatment
-----------------
* Behavioral: Intervention: Integrative Community Therapy-based Psychodrama
* Behavioral: Control: Improvisational Theatre


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Identify as having a CMC In grades kindergarten to 12th grade during the year recruited for the study 5 years of age and ≤ 19 years of age at the start of the intervention Able and willing to participate in improvisational theatre in spoken English Able to understand and answer standard questionnaires used for evaluation in English (with or without accommodation) Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: One group will receive a new behavioral intervention; the other group will receive improvisational theatre alone
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Integrative Community Therapy (ICT) Intervention Arm<br>Participants will perform scenes related to having a chronic medical condition and they will be guided through conversations about their feelings and coping methods. | Behavioral: Intervention: Integrative Community Therapy-based Psychodrama<br>* Participants produce theatre scenes depicting issues that they have experienced. Group leaders then use a guide to facilitate a discussion of participants' feelings, coping strategies, and sharing of local knowledge.<br>* Other names: Intervention: ICT-based Psychodrama;|
| Sham Comparator: Improvisational Theatre Arm<br>Participants will perform generic improvisational theatre with no instruction on feelings or coping methods. | Behavioral: Control: Improvisational Theatre<br>* Participants play improvisational theatre games.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and Depression | Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome | Baseline to 10 weeks | 
| Anxiety and Depression | Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome | Baseline to 6 months | 
| Anxiety and Depression | Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome | Baseline to 12 months | 
| Disease-Related Quality of Life | Disease-Related Quality of Life as evaluated by Qualitative Interview | Baseline to 10 weeks | 
| Disease-Related Quality of Life | Disease-Related Quality of Life as evaluated by Qualitative Interview | Baseline to 6 months | 
| Disease-Related Quality of Life | Disease-Related Quality of Life as evaluated by Qualitative Interview | Baseline to 12 months | 
| Disease-Related Quality of Life | Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome | Baseline to 10 weeks | 
| Disease-Related Quality of Life | Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome | Baseline to 6 months | 
| Disease-Related Quality of Life | Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome | Baseline to 12 months | 
| Knowledge and Utilization of Coping Strategies | Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview | Baseline to 10 weeks | 
| Knowledge and Utilization of Coping Strategies | Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview | Baseline to 6 months | 
| Knowledge and Utilization of Coping Strategies | Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview | Baseline to 12 months | 
| Knowledge and Utilization of Coping Strategies | Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome | Baseline to 10 weeks | 
| Knowledge and Utilization of Coping Strategies | Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome | Baseline to 6 months | 
| Knowledge and Utilization of Coping Strategies | Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome | Baseline to 12 months | 
| Empathy | Empathy as evaluated by Qualitative Interview | Baseline to 10 weeks | 
| Empathy | Empathy as evaluated by Qualitative Interview | Baseline to 6 months | 
| Empathy | Empathy as evaluated by Qualitative Interview | Baseline to 12 months |