Theatre in Adolescents With Chronic Medical Conditions (CMCs)

Not Applicable

Withdrawn

• Conditions: Chronic Disease

• Registration Number: NCT05468788
• Lead Sponsor: Geisinger Clinic

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.

Study Timeline

• Study Start: 2022-05-24
• Study First Submitted: 2022-07-12
• Study First Submitted QC: 2022-07-18
• Study First Posted: 2022-07-21
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-08
• Last Update Posted: 2024-08-12
• Primary Completion: 2024-08-31
• Study Completion: 2024-08-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease-Related Quality of Life	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
Anxiety and Depression	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
Knowledge and Utilization of Coping Strategies	Baseline to 12 months	Knowledge and Utilization of Coping Strategies as evaluated by KidCope Checklist; Scored 0-120; higher score indicates better outcome
Empathy	Baseline to 12 months	Empathy as evaluated by Qualitative Interview

Trial Locations

Locations (1)

Geisinger Primary Care South Wilkes-Barre; 🇺🇸 Wilkes-Barre, Pennsylvania, United States