Theatre in Adolescents With Chronic Medical Conditions (CMCs)

NCT05468788 | Withdrawn

• 1 other identifier: 2022-0322
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Disease

Outcome Measures

Primary Outcomes (18)

• 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

Study Arms (2)

Integrative Community Therapy (ICT) Intervention Arm

EXPERIMENTAL

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

Improvisational Theatre Arm

SHAM COMPARATOR

Participants will perform generic improvisational theatre with no instruction on feelings or coping methods.

Behavioral: Control: Improvisational Theatre

Interventions

Intervention: Integrative Community Therapy-based Psychodrama BEHAVIORAL

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.

Also known as: Intervention: ICT-based Psychodrama

Integrative Community Therapy (ICT) Intervention Arm

Control: Improvisational Theatre BEHAVIORAL

Participants play improvisational theatre games.

Improvisational Theatre Arm

Eligibility Criteria

• Age: 5 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Identify as having a CMC
• In grades kindergarten to 12th grade during the year recruited for the study
• 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)

You may not qualify if:

• None

Sponsors & Collaborators

• Geisinger Clinic: lead

Study Sites (1)

Geisinger Primary Care South Wilkes-Barre

Wilkes-Barre, Pennsylvania, 18702, United States

Location

Related Publications (16)

• 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.

  PMID: 30934877 BACKGROUND

• 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.

  PMID: 28215656 BACKGROUND

• 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.

  PMID: 31676391 BACKGROUND

• 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.

  PMID: 22224836 BACKGROUND

• 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.

  PMID: 12971193 BACKGROUND

• 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.

  PMID: 32811094 BACKGROUND

• 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.

  PMID: 33551907 BACKGROUND

• 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.

  PMID: 18383198 BACKGROUND

• 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.

  PMID: 21362006 BACKGROUND

• 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.

  PMID: 18375630 BACKGROUND

• 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.

  PMID: 18537845 BACKGROUND

• 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.

  PMID: 27925088 BACKGROUND

• 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.

  PMID: 29552422 BACKGROUND

• 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.

  PMID: 10937431 BACKGROUND

• 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.

  PMID: 11468499 BACKGROUND

• 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.

  PMID: 3216277 BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Karen A Ephlin, MD

  Geisinger Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group will receive a new behavioral intervention; the other group will receive improvisational theatre alone

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: July 21, 2022
• Study Start: May 24, 2022
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)