Theatre in Adolescents With Chronic Medical Conditions (CMCs)

August 8, 2024 updated by: Geisinger Clinic

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Wilkes-Barre, Pennsylvania, United States, 18702
        • Geisinger Primary Care South Wilkes-Barre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 17 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Integrative Community Therapy (ICT) Intervention Arm
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
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.
Other Names:
  • Intervention: ICT-based Psychodrama
Sham Comparator: Improvisational Theatre Arm
Participants will perform generic improvisational theatre with no instruction on feelings or coping methods.
Behavioral: Control: Improvisational Theatre
Participants play improvisational theatre games.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety and Depression
Time Frame: Baseline to 10 weeks
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
Time Frame: Baseline to 6 months
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
Time Frame: Baseline to 12 months
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
Time Frame: Baseline to 10 weeks
Disease-Related Quality of Life as evaluated by Qualitative Interview
Baseline to 10 weeks
Disease-Related Quality of Life
Time Frame: Baseline to 6 months
Disease-Related Quality of Life as evaluated by Qualitative Interview
Baseline to 6 months
Disease-Related Quality of Life
Time Frame: Baseline to 12 months
Disease-Related Quality of Life as evaluated by Qualitative Interview
Baseline to 12 months
Disease-Related Quality of Life
Time Frame: Baseline to 10 weeks
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
Time Frame: Baseline to 6 months
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
Time Frame: Baseline to 12 months
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
Time Frame: Baseline to 10 weeks
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Baseline to 10 weeks
Knowledge and Utilization of Coping Strategies
Time Frame: Baseline to 6 months
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Baseline to 6 months
Knowledge and Utilization of Coping Strategies
Time Frame: Baseline to 12 months
Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview
Baseline to 12 months
Knowledge and Utilization of Coping Strategies
Time Frame: Baseline to 10 weeks
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
Time Frame: Baseline to 6 months
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
Time Frame: Baseline to 12 months
Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Baseline to 12 months
Empathy
Time Frame: Baseline to 10 weeks
Empathy as evaluated by Qualitative Interview
Baseline to 10 weeks
Empathy
Time Frame: Baseline to 6 months
Empathy as evaluated by Qualitative Interview
Baseline to 6 months
Empathy
Time Frame: Baseline to 12 months
Empathy as evaluated by Qualitative Interview
Baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Geisinger Clinic

Investigators

  • Principal Investigator: Karen A Ephlin, MD, Geisinger Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2022

Primary Completion (Estimated)

August 31, 2024

Study Completion (Estimated)

August 31, 2024

Study Registration Dates

First Submitted

July 12, 2022

First Submitted That Met QC Criteria

July 18, 2022

First Posted (Actual)

July 21, 2022

Study Record Updates

Last Update Posted (Actual)

August 12, 2024

Last Update Submitted That Met QC Criteria

August 8, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0322

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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