- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03593564
Knowledge and Interpersonal Skills to Develop Exemplary Relationships (KINDER)
November 8, 2023 updated by: Donna Benton, University of Southern California
This pilot study will test the effect of an online asynchronous psychoeducational intervention to improve relationship quality and prevent verbal-type elder mistreatment in caregiving dyads.
The investigators will use a pre-post test design to test the feasibility and acceptability of this video-based intervention, and to determine the likelihood that participation in this program may improve caregiver relationship quality.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
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
-
-
California
-
Los Angeles, California, United States, 90007
- University of Southern California
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Provides assistance to someone over the age of 60 with an illness or a disability ("care recipient") who requires personal assistance from another person (e.g., bathing, preparing meals). (Assistance provided with at least 1 activity of daily living and/or at least 2 instrumental activities of daily living.)
- Person receiving care from the study participant has a cognitive impairment. This does not have to be diagnosed.
- Participant provides at least 8 hours of assistance to the care recipient per week
- Participant does not intend to place the care recipient in a skilled nursing facility or assisted living facility within 3 months of consenting into the study
Exclusion Criteria:
- Does not read and speak English
- Cannot access a computer and internet (needed to complete lessons)
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: KINDER Participant
The intervention will be provided with a 8-part psychoeducational intervention delivered online on a weekly basis.
Online modules will be comprised of a short (approximately 3 minute) videos followed by more specific text-based information and links to additional resources.
At the end of the module, participants will complete a short quiz, followed by a reflection exercise to reinforce learning.
Each model, participants will be asked to select a goal to complete a pleasurable activity and receive an option to set a text or email reminder to do so.
|
KINDER is an online course for people assisting an older adult with dementia.
It is intended to improve the quality of caregiver's relationship with the care recipient and reduce the chance of risky relationship behavior (e.g., yelling).
Courses will cover topics including understanding cognitive impairments, navigating evolving roles, and dealing with frustration.
During this course, participants will learn skills to deal with difficult situations caregivers frequently encounter in ways that support a healthy caregiving relationship.
Videos will be story-based and represent different types of caregiving relationships and challenges encountered.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in frequency of verbal mistreatment
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.
|
This scale will measure frequency of verbal mistreatment using a measure based on the Conflict Tactics Scale (Straus et al., 1996), with additional questions from other items (Acierno et al., 2010; Beach et al., 2005; Conrad et al., 2011; Deliema et al., 2012)
|
This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.
|
|
Change in the number of positive aspects of the relationship with the care recipient (Dyadic Relationship Scale)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.
|
Participants are asked how much they agree with positive statements about their relationship with the care receiver on a 0 to 3 scale.
This item comes from Sebern & Whitlatch (2007)
|
This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in caregiver competence (Caregiving Competence Scale)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
|
We will use the Caregiving Competence Scale developed by Pearlin and colleagues (1990)
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This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
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Change in perceived stress (Perceived Stress Scale)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
|
We will use the Perceived Stress Scale developed by Cohen & Williamson (1988)
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This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
|
|
Change in caregiver burden (Zarit Burden Index)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
|
We will use the Zarit Burden Index developed by Zarit and colleagues (1980)
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This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
|
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Change in depression (Patient Health Questionnaire-9)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
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We will use the Patient Health Questionnaire-9 (Kroenke et al., 2001)
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This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
|
|
Change in caregiver mastery (Caregiver Mastery Scale)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
|
We will use the Caregiver Mastery Scale developed by Pearlin & Schooler (1978)
|
This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Donna Benton, PhD, University of Southern California
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
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Zarit SH, Reever KE, Bach-Peterson J. Relatives of the impaired elderly: correlates of feelings of burden. Gerontologist. 1980 Dec;20(6):649-55. doi: 10.1093/geront/20.6.649. No abstract available.
- Sebern MD, Whitlatch CJ. Dyadic relationship scale: a measure of the impact of the provision and receipt of family care. Gerontologist. 2007 Dec;47(6):741-51. doi: 10.1093/geront/47.6.741.
- Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
- Pearlin LI, Mullan JT, Semple SJ, Skaff MM. Caregiving and the stress process: an overview of concepts and their measures. Gerontologist. 1990 Oct;30(5):583-94. doi: 10.1093/geront/30.5.583.
- Straus, M. A., Hamby, S. L., Boney-McCoy, S., Sugarman, D. B. The revised conflict tactics scales (CTS2) development and preliminary psychometric data. Journal of Family Issues 17(3): 283-316, 1996.
- DeLiema M, Gassoumis ZD, Homeier DC, Wilber KH. Determining prevalence and correlates of elder abuse using promotores: low-income immigrant Latinos report high rates of abuse and neglect. J Am Geriatr Soc. 2012 Jul;60(7):1333-9. doi: 10.1111/j.1532-5415.2012.04025.x. Epub 2012 Jun 14.
- Acierno R, Hernandez MA, Amstadter AB, Resnick HS, Steve K, Muzzy W, Kilpatrick DG. Prevalence and correlates of emotional, physical, sexual, and financial abuse and potential neglect in the United States: the National Elder Mistreatment Study. Am J Public Health. 2010 Feb;100(2):292-7. doi: 10.2105/AJPH.2009.163089. Epub 2009 Dec 17.
- Conrad KJ, Iris M, Ridings JW, Langley K, Anetzberger GJ. Self-report measure of psychological abuse of older adults. Gerontologist. 2011 Jun;51(3):354-66. doi: 10.1093/geront/gnq103. Epub 2010 Dec 20.
- Cohen, S, Williamson, G. Perceived stress in a probability sample of the United States. In S. Spacapan & S. Oskamp (Eds.), The social psychology of health: Claremont Symposium on applied social psychology. Newbury Park, CA: Sage, 1988
- Beach SR, Schulz R, Williamson GM, Miller LS, Weiner MF, Lance CE. Risk factors for potentially harmful informal caregiver behavior. J Am Geriatr Soc. 2005 Feb;53(2):255-61. doi: 10.1111/j.1532-5415.2005.53111.x.
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)
December 15, 2020
Primary Completion (Actual)
November 8, 2023
Study Completion (Actual)
November 8, 2023
Study Registration Dates
First Submitted
June 26, 2018
First Submitted That Met QC Criteria
July 9, 2018
First Posted (Actual)
July 20, 2018
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- KINDER 18-01-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Only de-identified participant data will be available to other researchers at the end of our study.
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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