Theatre in Adolescents With Chronic Medical Conditions (CMCs)
Primary Purpose
Chronic Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention: Integrative Community Therapy-based Psychodrama
Control: Improvisational Theatre
Sponsored by
About this trial
This is an interventional prevention trial for Chronic Disease
Eligibility Criteria
Inclusion Criteria:
- Identify as having a CMC
- ≥5 years of age and ≤17 years of age on June 1st, 2022
- 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
Sites / Locations
- Geisinger Primary Care South Wilkes-BarreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Integrative Community Therapy (ICT) Intervention Arm
Improvisational Theatre Arm
Arm Description
Participants will perform scenes related to having a chronic medical condition and they will be guided through conversations about their feelings and coping methods.
Participants will perform generic improvisational theatre with no instruction on feelings or coping methods.
Outcomes
Primary Outcome Measures
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
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
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
Disease-Related Quality of Life
Disease-Related Quality of Life as evaluated by Qualitative Interview
Disease-Related Quality of Life
Disease-Related Quality of Life as evaluated by Qualitative Interview
Disease-Related Quality of Life
Disease-Related Quality of Life as evaluated by Qualitative Interview
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
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
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
Knowledge and Utilization of Coping Strategies
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Knowledge and Utilization of Coping Strategies
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Knowledge and Utilization of Coping Strategies
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
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
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
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
Empathy
Empathy as evaluated by Qualitative Interview
Empathy
Empathy as evaluated by Qualitative Interview
Empathy
Empathy as evaluated by Qualitative Interview
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05468788
Brief Title
Theatre in Adolescents With Chronic Medical Conditions (CMCs)
Official Title
Evaluating the Use of Theatre to Decrease Depression and Anxiety Among Adolescents With Chronic Medical Conditions (CMCs)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Geisinger Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
One group will receive a new behavioral intervention; the other group will receive improvisational theatre alone
Masking
Participant
Masking Description
The participants will not know which group they are in, as they will not be familiar with the particular procedure of the intervention being studied
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Integrative Community Therapy (ICT) Intervention Arm
Arm Type
Experimental
Arm Description
Participants will perform scenes related to having a chronic medical condition and they will be guided through conversations about their feelings and coping methods.
Arm Title
Improvisational Theatre Arm
Arm Type
Sham Comparator
Arm Description
Participants will perform generic improvisational theatre with no instruction on feelings or coping methods.
Intervention Type
Behavioral
Intervention Name(s)
Intervention: Integrative Community Therapy-based Psychodrama
Other Intervention Name(s)
Intervention: ICT-based Psychodrama
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Control: Improvisational Theatre
Intervention Description
Participants play improvisational theatre games.
Primary Outcome Measure Information:
Title
Anxiety and Depression
Description
Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome
Time Frame
Baseline to 10 weeks
Title
Anxiety and Depression
Description
Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome
Time Frame
Baseline to 6 months
Title
Anxiety and Depression
Description
Anxiety and Depression as evaluated by the Revised Children's Anxiety and Depression Scale; Scored 0-30; higher score indicates worse outcome
Time Frame
Baseline to 12 months
Title
Disease-Related Quality of Life
Description
Disease-Related Quality of Life as evaluated by Qualitative Interview
Time Frame
Baseline to 10 weeks
Title
Disease-Related Quality of Life
Description
Disease-Related Quality of Life as evaluated by Qualitative Interview
Time Frame
Baseline to 6 months
Title
Disease-Related Quality of Life
Description
Disease-Related Quality of Life as evaluated by Qualitative Interview
Time Frame
Baseline to 12 months
Title
Disease-Related Quality of Life
Description
Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome
Time Frame
Baseline to 10 weeks
Title
Disease-Related Quality of Life
Description
Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome
Time Frame
Baseline to 6 months
Title
Disease-Related Quality of Life
Description
Disease-Related Quality of Life as evaluated by Pediatric Quality of Life Inventory; Scored 0-100; higher score indicates better outcome
Time Frame
Baseline to 12 months
Title
Knowledge and Utilization of Coping Strategies
Description
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Time Frame
Baseline to 10 weeks
Title
Knowledge and Utilization of Coping Strategies
Description
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Time Frame
Baseline to 6 months
Title
Knowledge and Utilization of Coping Strategies
Description
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Time Frame
Baseline to 12 months
Title
Knowledge and Utilization of Coping Strategies
Description
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Time Frame
Baseline to 10 weeks
Title
Knowledge and Utilization of Coping Strategies
Description
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Time Frame
Baseline to 6 months
Title
Knowledge and Utilization of Coping Strategies
Description
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Time Frame
Baseline to 12 months
Title
Empathy
Description
Empathy as evaluated by Qualitative Interview
Time Frame
Baseline to 10 weeks
Title
Empathy
Description
Empathy as evaluated by Qualitative Interview
Time Frame
Baseline to 6 months
Title
Empathy
Description
Empathy as evaluated by Qualitative Interview
Time Frame
Baseline to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karen A Ephlin, MD
Phone
570-808-6672
Email
theatre-as-medicine@som.geisinger.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Maura M Sheehan, MPH
Email
theatre-as-medicine@som.geisinger.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen A Ephlin, MD
Organizational Affiliation
Geisinger Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Geisinger Primary Care South Wilkes-Barre
City
Wilkes-Barre
State/Province
Pennsylvania
ZIP/Postal Code
18702
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karen A Ephlin, MD
Phone
570-808-6672
Email
theatre-as-medicine@som.geisinger.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Theatre in Adolescents With Chronic Medical Conditions (CMCs)
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