Theatre in Adolescents With Chronic Medical Conditions (CMCs)

Chronic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05468788
• Other study ID #: 2022-0322
• Status: Recruiting
• Phase: N/A
• Start date: May 24, 2022
• Est. completion date: August 31, 2024

Study information

• Verified date: August 2023
• Source: Geisinger Clinic
• Contact: Karen A Ephlin, MD
• Phone: 570-808-6672
• Email: theatre-as-medicine[@]som.geisinger.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

Intervention

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.
• Control: Improvisational Theatre
Participants play improvisational theatre games.

Locations

Country	Name	City	State
United States	Geisinger Primary Care South Wilkes-Barre	Wilkes-Barre	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Geisinger Clinic

Country where clinical trial is conducted

United States, 

References & Publications (16)

Blacker J, Watson A, Beech AR. A combined drama-based and CBT approach to working with self-reported anger aggression. Crim Behav Ment Health. 2008;18(2):129-37. doi: 10.1002/cbm.686. — View Citation

Chorpita BF, Yim L, Moffitt C, Umemoto LA, Francis SE. Assessment of symptoms of DSM-IV anxiety and depression in children: a revised child anxiety and depression scale. Behav Res Ther. 2000 Aug;38(8):835-55. doi: 10.1016/s0005-7967(99)00130-8. — View Citation

Cobham VE, Hickling A, Kimball H, Thomas HJ, Scott JG, Middeldorp CM. Systematic Review: Anxiety in Children and Adolescents With Chronic Medical Conditions. J Am Acad Child Adolesc Psychiatry. 2020 May;59(5):595-618. doi: 10.1016/j.jaac.2019.10.010. Epub 2019 Oct 30. — View Citation

Compas BE, Jaser SS, Dunn MJ, Rodriguez EM. Coping with chronic illness in childhood and adolescence. Annu Rev Clin Psychol. 2012;8:455-80. doi: 10.1146/annurev-clinpsy-032511-143108. Epub 2011 Dec 20. — View Citation

Daykin N, Orme J, Evans D, Salmon D, McEachran M, Brain S. The impact of participation in performing arts on adolescent health and behaviour: a systematic review of the literature. J Health Psychol. 2008 Mar;13(2):251-64. doi: 10.1177/1359105307086699. — View Citation

Feniger-Schaal R, Koren-Karie N. Using Drama Therapy to Enhance Maternal Insightfulness and Reduce Children's Behavior Problems. Front Psychol. 2021 Jan 20;11:586630. doi: 10.3389/fpsyg.2020.586630. eCollection 2020. — View Citation

Greenberg MT, Weissberg RP, O'Brien MU, Zins JE, Fredericks L, Resnik H, Elias MJ. Enhancing school-based prevention and youth development through coordinated social, emotional, and academic learning. Am Psychol. 2003 Jun-Jul;58(6-7):466-74. doi: 10.1037/0003-066x.58.6-7.466. — View Citation

Hersov L. Psychotherapy for Children and Adolescents. Evidence-based Treatments and Case Examples. Child Adolesc Ment Health. 2006 May;11(2):124-125. doi: 10.1111/j.1475-3588.2006.00399_5.x. No abstract available. — View Citation

Jones LC, Mrug S, Elliott MN, Toomey SL, Tortolero S, Schuster MA. Chronic Physical Health Conditions and Emotional Problems From Early Adolescence Through Midadolescence. Acad Pediatr. 2017 Aug;17(6):649-655. doi: 10.1016/j.acap.2017.02.002. Epub 2017 Feb 12. — View Citation

Joronen K, Hakamies A, Astedt-Kurki P. Children's experiences of a drama programme in social and emotional learning. Scand J Caring Sci. 2011 Dec;25(4):671-8. doi: 10.1111/j.1471-6712.2011.00877.x. Epub 2011 Mar 1. — View Citation

Joronen K, Rankin SH, Astedt-Kurki P. School-based drama interventions in health promotion for children and adolescents: systematic review. J Adv Nurs. 2008 Jul;63(2):116-31. doi: 10.1111/j.1365-2648.2008.04634.x. — View Citation

Miranda NA, Berardinelli LM, Saboia VM, Brito ID, Santos RD. Interdisciplinary care praxis in groups of people living with fibromyalgia. Rev Bras Enferm. 2016 Nov-Dec;69(6):1115-1123. doi: 10.1590/0034-7167-2016-0279. English, Portuguese. — View Citation

Spirito A, Stark LJ, Williams C. Development of a brief coping checklist for use with pediatric populations. J Pediatr Psychol. 1988 Dec;13(4):555-74. doi: 10.1093/jpepsy/13.4.555. No abstract available. — View Citation

Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006. — View Citation

Weigensberg MJ, Vigen C, Sequeira P, Spruijt-Metz D, Juarez M, Florindez D, Provisor J, Peters A, Pyatak EA. Diabetes Empowerment Council: Integrative Pilot Intervention for Transitioning Young Adults With Type 1 Diabetes. Glob Adv Health Med. 2018 Mar 8;7:2164956118761808. doi: 10.1177/2164956118761808. eCollection 2018. — View Citation

Young KS, Sandman CF, Craske MG. Positive and Negative Emotion Regulation in Adolescence: Links to Anxiety and Depression. Brain Sci. 2019 Mar 29;9(4):76. doi: 10.3390/brainsci9040076. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Disease-Related Quality of Life	Disease-Related Quality of Life as evaluated by Qualitative Interview	Baseline to 10 weeks
Primary	Disease-Related Quality of Life	Disease-Related Quality of Life as evaluated by Qualitative Interview	Baseline to 6 months
Primary	Disease-Related Quality of Life	Disease-Related Quality of Life as evaluated by Qualitative Interview	Baseline to 12 months
Primary	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
Primary	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
Primary	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
Primary	Knowledge and Utilization of Coping Strategies	Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview	Baseline to 10 weeks
Primary	Knowledge and Utilization of Coping Strategies	Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview	Baseline to 6 months
Primary	Knowledge and Utilization of Coping Strategies	Knowledge and Utilization of Coping Strategies as evaluated by Qualitative Interview	Baseline to 12 months
Primary	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
Primary	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
Primary	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
Primary	Empathy	Empathy as evaluated by Qualitative Interview	Baseline to 10 weeks
Primary	Empathy	Empathy as evaluated by Qualitative Interview	Baseline to 6 months
Primary	Empathy	Empathy as evaluated by Qualitative Interview	Baseline to 12 months