NCT03593564

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 26, 2018

Completed
24 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
2.4 years until next milestone

Study Start

First participant enrolled

December 15, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 8, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

2.9 years

First QC Date

June 26, 2018

Last Update Submit

November 8, 2023

Conditions

Keywords

Pilot StudyCognitive Behavioral TherapyIntervention Study

Outcome Measures

Primary Outcomes (2)

  • Change in frequency of verbal mistreatment

    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)

    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.

Secondary Outcomes (5)

  • Change in caregiver competence (Caregiving Competence Scale)

    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 perceived stress (Perceived Stress Scale)

    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)

    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 depression (Patient Health Questionnaire-9)

    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)

    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.

Study Arms (1)

KINDER Participant

EXPERIMENTAL

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.

Behavioral: KINDER

Interventions

KINDERBEHAVIORAL

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.

KINDER Participant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Does not read and speak English
  • Cannot access a computer and internet (needed to complete lessons)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Southern California

Los Angeles, California, 90007, United States

Location

Related Publications (11)

  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 22697790BACKGROUND
  • 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.

    PMID: 20019303BACKGROUND
  • 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.

    PMID: 21173437BACKGROUND
  • 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.

    PMID: 7203086BACKGROUND
  • Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.

    PMID: 649936BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 2276631BACKGROUND
  • 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.

    PMID: 15673349BACKGROUND
  • 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.

    PMID: 18192628BACKGROUND

Study Officials

  • Donna Benton, PhD

    University of Southern California

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: The investigators will evaluate the KINDER program using pre- and post-test analysis. Eligible and consented subjects enrolled on a rolling basis. After enrollment, all caregivers will complete a baseline assessment. Caregivers will receive the intervention (8 lessons, delivered once per week) and will be asked to complete a reassessment after 10 weeks. Two months later, participants will be asked to complete a second reassessment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 20, 2018

Study Start

December 15, 2020

Primary Completion

November 8, 2023

Study Completion

November 8, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Only de-identified participant data will be available to other researchers at the end of our study.

Locations