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Not yet recruitingNCT07216950KINDERUpdated Sep 17, 2026

Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)

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

Phase
Not applicable
Study type
Interventional
Enrollment
260
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Elder Mistreatment
  • Elder Abuse
  • Quality of Care
  • Dementia
  • Caregiving

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03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age range: from 18 to No upper limit;
  • Be a family member to an individual living with AD/ADRD;
  • Provide assistance with at least two instrumental activities of daily living or one activity of daily living;
  • Provides at least 4 hours of caregiving per day and sees the care recipient in-person at least 2 times per week on average
  • The care recipient is at least age 65 or older
  • Report an AD8 Dementia Screening score for care recipients of at least 2;
  • Commit to attending at three discussion sessions;
  • Have reliable access to internet and email, and to be able to attend synchronous sessions using the Zoom videoconferencing platform.
  • Caregiver lives in any of the following states, which may require mandetory reporting of elder mistreatment when responding to survey questions:

Delaware, Florida, Indiana, Kentucky, Louisiana, Mississippi, Montana, New Hampshire, New Mexico, North Carolina, Oklahoma, Rhode Island, South Carolina, Tennessee, Texas, Utah, Wyoming

Exclusion criteria

Exclusion Criteria:

  • Are unable to read or speak English;
  • Previously participated in Learning Skills Together (NCT05846984) or KINDER pilot study;
  • Have plans to place the care recipient in a skilled nursing facility within the next 8 months (i.e., study duration)
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
260 participants (estimated)

Study arms

  • Experimental
    KINDER Intervention Arm

    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

  • Placebo comparator
    Control Condition

    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

Interventions

  • BehavioralKnowledge and Interpersonal Skills to Develop Enhanced Relationships

    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).

  • BehavioralHealthy Living for the Caregiver

    Caregivers in the control arm will receive a workbook that covers 8 weeks of content focused on healthy living (e.g., nutrition).

05

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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 outcomes

  1. 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

  2. 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

  3. 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

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Study locations

1 site
  • Case Western Reserve University
    Cleveland, Ohio 44106, United States
    • Kylie Principal Investigator · Contact · knm77@case.edu · 216-368-1928
07

References and documents

Individual participant data

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, Sap, Icf, Analytic code

No publications or documents are linked to this record.

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Registry details

Key details

Study ID
NCT07216950
Lead sponsor
Case Western Reserve University
Collaborators
National Institute on Aging (NIA)
Responsible party
Kylie Meyer (Principal Investigator, Case Western Reserve University) — Principal investigator
First posted
Oct 15, 2025
Start date
Dec 15, 2026 (estimated)
Primary completion
Jun 15, 2029 (estimated)
Completion
Mar 15, 2030 (estimated)
Last update
Sep 17, 2026

Study contacts

Kylie Meyer, PhD
Contact
knm77@case.edu
2163681928
Lauren Project Manager
Contact
ltj15@case.edu
2163681928

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
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