An interventional study of Knowledge and Interpersonal Skills to Develop Enhanced Relationships and Healthy Living for the Caregiver in Elder Mistreatment, Elder Abuse and Quality of Care, sponsored by Case Western Reserve University. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Case Western Reserve University · Not applicable, Interventional, and Prevention
The Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER) intervention was developed to prevent psychological elder abuse (EA) and promote high-quality caregiving by lowering relationship strain and developing CG resourcefulness. The goal of this two-arm, randomized control trial is to determine the efficacy of KINDER at mitigating psychological EA by family caregivers to persons living with dementia and to describe how the intervention may work to reduce psychological EA.
2,372 studies on the registry are indexed under Dementia; 574 are open to participants now.
This study's planned enrollment of 260 is above the median of 90 across 1,758 interventional studies indexed under Dementia.
Browse Dementia studies →Case Western Reserve University is the lead sponsor of 160 studies on the registry; 28 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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Delaware, Florida, Indiana, Kentucky, Louisiana, Mississippi, Montana, New Hampshire, New Mexico, North Carolina, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Utah, Wyoming
Exclusion Criteria:
KINDER is an 8-week intervention that consists of three facilitated group discussion sessions conducted over Zoom with a small group of caregivers, in addition to self-paced lessons delivered using a printed or PDF workbook, depending on participant preference. Throughout KINDER, caregivers reflect on their relationship, including how their behavior toward the care recipient may need to change considering new vulnerabilities with dementia, and how to communicate about topics that often contribute to conflict, such as balancing safety and independence (e.g., driving).
Behavioral: Knowledge and Interpersonal Skills to Develop Enhanced Relationships
Caregivers in the control arm will receive a workbook that covers 8 weeks of content focused on healthy living (e.g., nutrition).
Behavioral: Healthy Living for the Caregiver
KINDER is an 8-week intervention that consists of three facilitated group discussion sessions conducted over Zoom with a small group of caregivers, in addition to self-paced lessons delivered using a printed or PDF workbook, depending on participant preference. Throughout KINDER, caregivers reflect on their relationship, including how their behavior toward the care recipient may need to change considering new vulnerabilities with dementia, and how to communicate about topics that often contribute to conflict, such as balancing safety and independence (e.g., driving).
Caregivers in the control arm will receive a workbook that covers 8 weeks of content focused on healthy living (e.g., nutrition).
Psychological Elder Abuse
The investigators will use a modified version of the Conflict Tactics Scale 2 to measure psychological EA (MCTS 2). This scale includes five psychological EA behaviors, such as insulting, swearing at, or yelling at the care recipient, as well as threatening to stop taking care of the care recipient, placing them in a nursing home, threatening physical harm, and stomping out of the room. Participants will be asked to describe the frequency of each behavior in the last 2 months, such that response options will include: None, Once, Twice, 3 to 5 times, 6 to 10 times, and More than 10 times. Scores range from 0 to 30. Higher scores indicate greater frequency of mistreatment. Higher scores indicate greater frequency of abuse. The outcome measure will use the average change score from baseline scores until each post-intervention survey.
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Quality of Caregiving
To measure quality of care, the investigators will use the 11-item Exemplary Caregiving Scale, which focuses on providing care that meets the care recipient's needs (α=0.73) and is respectful (α=0.76). Response options include Never, Sometimes, Often, and Always (range: 11 to 44). Higher scores indicate higher quality of caregiving. The outcome measure will use the average change score from baseline scores until each post-intervention survey.
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Resourcefulness
Resourcefulness is measured using the 28-item Caregiver Resourcefulness Scale (α=0.85). This scale has two factors: one focused on help-seeking and another on self-help. Caregivers are asked the frequency at which they use different strategies to manage challenges, and may respond: Not at all like me (0), Pretty much not like me (1), A little bit not like me (2), A little bit like me (3), Pretty much like much like me (4), or Very much like me (5). Items are added together to create a total score. Scores range from 0 to 140, where higher scores indicate higher levels of resourcefulness. The outcome measure will use the average change score from baseline scores until each post-intervention survey.
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Caregiving Relationship Strain
Relationship strain will be measured using the 5-item Strain Scale of the Dyadic Relationship Scale (α=0.69). Respondents are asked to indicate agreement with statements such as, "The patient made too many requests," and may indicate Strongly Disagree, Disagree, Agree, or Strongly Agree. The scale has a range of scores from 4 to 20, where higher scores indicate greater levels of relationship strain. The outcome measure will use the average change score from baseline scores until each post-intervention survey.
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Other Types of Elder Abuse
Other types of elder abuse will be measured with the Geriatric Mistreatment Scale (GMS). The GMS is a 22-items scale that measures psychological, physical, sexual, financial abuse, and neglect using "yes" and "no" questions (range of response: 0 to 22). Higher scores indicate greater frequency of abuse. The outcome measure will use the average change score from baseline scores until each post-intervention survey.
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Depressive Cognitions
Caregiver depressive cognitions will be measured using the Depressive Cognitions Scale, which measures thinking patterns preceding depression. The 8-item Depressive Cognitions Scale is validated for use among AD/ADRD CGs, with a Cronbach's alpha of 0.75 to 0.88. Respondents indicate their level of agreement with each statement on a 6-point Likert scale with responses from "totally disagree" to "totally agree." Scores range from 0 to 40. Higher scores indicate higher levels of depressive cognitions. The outcome measure will use the average change score from baseline scores until each post-intervention survey.
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Social Support
Social Support will be measured using the NIH Toolbox measure for emotional support. This scale has 8 items about how frequently individuals access support (e.g., someone who understands my problems). Scores range from Never, Rarely, Sometimes, Usually, and Always (range=8-40). Higher scores indicate higher levels of social support. The outcome measure will use the average change score from baseline scores until each post-intervention survey.
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Plan to share: Yes — Baseline and follow up surveys with participants; Referral, screening, enrollment, and retention data; Fidelity surveys. All data will be de-identified.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Analytic code
Time frame: Information will be shared no later than the time of an associated publication or the end of the performance period, whichever comes first. Data will be made available indefinitely.
Access criteria: Survey data and metadata will be shared through National Archive of Computerized Data on Aging (NACDA) as open access. Once prepared, data will be released by NACDA. NACDA users must register and agree to the Terms of Use, such as agreeing not to attempt to identify individual participants. Data users also agree not to share or redistribute data downloads
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Jun 2029, 30 months later.
Of 855 non-industry interventional studies with no phase under Dementia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 30 months is above that.
Counting every sponsor, half of 901 studies reached it within 25 months; a quarter within 11 and three quarters within 43.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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