Improving Care Through Improv: Promoting Mastery in the Moment

The goals of this clinical trial are to: 1) refine the training program, "Improving Care though Improv;" and 2) test the program for its influence self-perceived caregiving mastery (i.e., how persons assess their ability to provide care) among informal caregivers of persons living with moderate dementia. Forty-three informal caregivers will be involved in testing the training program. These individuals will be assigned to groups of between 8 to12 caregivers and take part in weekly 2-hour sessions held over a 4-week period. These caregivers will be taught improvisational (improv) theater skills, which involves being in the moment, self-awareness, and responsiveness to others. This group also will be asked to answer surveys questions about themselves and the person receiving care at three timepoints and invited to provide feedback on their training experiences.

Study Overview

• Status: Completed
• Conditions: Caregiver Burden
• Intervention / Treatment: Behavioral: Training program pilot

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30302
      • Georgia State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Actively engaged in the care of community-dwelling persons living with moderate dementia (4 or 5 on a 7-point dementia-staging scale) who is not likely to be institutionalized within the next 6 months
• Able to attend at least 3 of the 4 in-person sessions
• Ability to communicate in English

Exclusion Criteria: Potential participants were excluded if they did not meet the above criteria or anticipated moving their person to a skilled nursing facility within the next 6 months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Informal Caregivers of Persons Living with Dementia; Participants will receive the training program, "Improving Care through Improv." This involves four weekly 2-hour in-person training sessions.	Behavioral: Training program pilot; This intervention for informal caregivers consists of training that will introduce participants to improvisational (improv) theatre and teach its core communication skills.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pearlin Mastery, Loss, and Competence: Caregiver Competence Subscale	4-item Likert-type scale; scores range from 4 to 16 with higher scores indicating greater feelings of competence.	at baseline, upon training completion (Week 4), and three months post baseline.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived Stress Scale	14-item Likert-type scale. Scores range from 0 to 56 with higher scores indicating greater stress.	at baseline, upon training completion (Week 4), and three months post baseline.
Center for Epidemiological Studies-Depression Scale	20-item Likert-type scale. Scores range from 0 to 60 with higher scores indicating greater depression.	at baseline, upon training completion (Week 4), and three months post baseline.
State-Trait Anxiety Inventory	20-item Likert-type scale. Scores range from 20 to 80 with higher scores indicating greater anxiety.	at baseline, upon training completion (Week 4), and three months post baseline.
Zarit Burden Inventory	22-item scale with 4-point Likert scale responses. Scores range from 0 to 88 with higher scores indicating greater burden.	at baseline, upon training completion (Week 4), and three months post baseline.
Quality of Life-Alzheimer's Disease Scale	13 items with a 4-point Likert scale. Scores range from 13 to with 52 with higher scores indicating greater quality of life among persons living with dementia	at baseline, upon training completion (Week 4), and three months post baseline.
Revised Memory and Behavioral Problems Checklist - FREQUENCY	24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.	at baseline, upon training completion (Week 4), and three months post baseline.
Revised Memory and Behavioral Problems Checklist - REACTION	24-item scale with 4-point Likert scale responses. Scores range from 0 to 96 with higher scores indicating greater behavioral expressions observed by caregivers among persons living with dementia.	at baseline, upon training completion (Week 4), and three months post baseline.

Collaborators and Investigators

• Sponsor: Georgia State University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Candace L Kemp, PhD, Georgia State Univeristy

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): May 20, 2024

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: P30AG064200 (U.S. NIH Grant/Contract); DBSR-11114 (Other Identifier: NIA CROMS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data from this study will be made available to qualified researchers through a data sharing agreement that is consistent with NIH data sharing policies, as well as policies and practices established by the Roybal Center for Dementia Caregiving Mastery at Emory University. The data to be collected include common data elements, including the Caregiver Mastery Scale developed by Pearlin and colleagues, as well as demographic characteristics. Although these data will be de-identified prior to release for sharing, there remains a possibility of deductive disclosure of participants with unusual characteristics. Therefore, this data sharing agreement will require: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.
• IPD Sharing Time Frame: Study data will be made available no later than the on-line publication date of the main findings from the final dataset.
• IPD Sharing Access Criteria: Researchers must qualify and enter into a data sharing agreement. The agreement requires: 1) a commitment only to use the data for research purposes and not to identify any individual participant; 2) a commitment to securing the data using appropriate computer technology; and 3) a commitment to destroy or return the data after analyses are completed.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No