CaregiversKINDERNCT03593564
Knowledge and Interpersonal Skills to Develop Exemplary Relationships
A study testing KINDER in people with Caregivers and Family Relations, run by University of Southern California at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregivers, Family Relations, Domestic Violence
- What is being tested?
- KINDER
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2020to 8 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Does not read and speak English
- Cannot access a computer and internet (needed to complete lessons)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Southern California
Los Angeles, California, 90007
About this study
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.
- Conditions
- Caregivers, Family Relations, Domestic Violence, Elder Abuse
- Being tested
- KINDER
- Keywords
- Pilot Study, Cognitive Behavioral Therapy, Intervention Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KINDERBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: KINDER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
We will use the Caregiving Competence Scale developed by Pearlin and colleagues (1990)
Measured: 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)
We will use the Perceived Stress Scale developed by Cohen \& Williamson (1988)
Measured: 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)
We will use the Zarit Burden Index developed by Zarit and colleagues (1980)
Measured: 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)
We will use the Patient Health Questionnaire-9 (Kroenke et al., 2001)
Measured: 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)
We will use the Caregiver Mastery Scale developed by Pearlin \& Schooler (1978)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2018
- Study start15 Dec 2020
- Primary completion8 Nov 2023
- Study completion8 Nov 2023
Why it stopped: The study team experienced technology challenges with the digital platform used to deliver the intervention and to collect data. Data collection surveys would be automatically sent to participants before participants completed intervention modules.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CaregiversStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- Archstone Foundation
- Responsible party
- Principal investigator, Donna Benton, University of Southern California
- Investigators
- Donna Benton, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03593564
- Sponsor's protocol ID
- KINDER 18-01-06
- Acronym
- KINDER
- Status last verified
- Nov 2023
- First submitted
- 26 Jun 2018
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Only de-identified participant data will be available to other researchers at the end of our study.
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.
PubMed 11556941Straus, 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.
PubMed 22697790Acierno 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.
PubMed 20019303Conrad 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.
PubMed 21173437Zarit 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.
PubMed 7203086Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
PubMed 649936Cohen, 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
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.
PubMed 2276631Beach 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.
PubMed 15673349Sebern 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.
PubMed 18192628
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Interpersonal Skills to Develop Exemplary Relationships
- ClinicalTrials.gov ID
- NCT03593564
- Acronym / sponsor ID
- KINDER / KINDER 18-01-06
- Conditions
- Caregivers, Family Relations, Domestic Violence, Elder Abuse
- Keywords
- Pilot Study, Cognitive Behavioral Therapy, Intervention Study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study team experienced technology challenges with the digital platform used to deliver the intervention and to collect data. Data collection surveys would be automatically sent to participants before participants completed intervention modules.
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- Archstone Foundation
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 8 Nov 2023 (actual)
- Study completion
- 8 Nov 2023 (actual)
- First posted
- 20 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| KINDER Participant | Experimental | Behavioral: KINDERThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Does not read and speak English
- Cannot access a computer and internet (needed to complete lessons)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KINDERKINDER 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. | Behavioural | KINDER Participant |
Primary outcome
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)
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)
5 secondary outcomes
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.
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: The study team experienced technology challenges with the digital platform used to deliver the intervention and to collect data. Data collection surveys would be automatically sent to participants before participants completed intervention modules.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Background: PubMed 11556941Kroenke 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.
- BackgroundStraus, 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: PubMed 22697790DeLiema 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.
- Background: PubMed 20019303Acierno 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.
- Background: PubMed 21173437Conrad 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.
- Background: PubMed 7203086Zarit 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.
- Background: PubMed 649936Pearlin LI, Schooler C. The structure of coping. J Health Soc Behav. 1978 Mar;19(1):2-21. No abstract available.
- BackgroundCohen, 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: PubMed 2276631Pearlin 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.
- Background: PubMed 15673349Beach 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.
- Background: PubMed 18192628Sebern 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.
- Individual participant dataSharing planned: No. Only de-identified participant data will be available to other researchers at the end of our study.
Related trials for Caregivers
Recruiting
Developing a Scalable Tobacco Cessation Program for Cancer Survivors and Caregivers
Nicotine Use, Tobacco Use
Active, not recruiting
Emergency Preparedness for Caregivers of Persons With Dementia: Disaster PrepWise
Caregiver Resilience and Stress
Not yet recruitingObservational study
Factors Influencing Adoption of a Novel Malaria Treatment in Côte d'Ivoire, Ghana, and Rwanda
Malaria
Not yet recruitingObservational study
Phase 1: Thrive Together
Attention-Deficit/Hyperactivity Disorder (ADHD)
Recruiting
The WeACT Program for Family Caregivers of People Living With Dementia
Depression, Caregivers
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Donna Benton, PhD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KINDER in people with Caregivers and Family Relations, run by University of Southern California at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study team experienced technology challenges with the digital platform used to deliver the intervention and to collect data. Data collection surveys would be automatically sent to participants before participants completed intervention modules.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03593564, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.