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KINDER

Intervention Test for Preventing Elder Abuse in Family Caregiving

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Study AimThis clinical trial is a phase 2 interventional study that aims to prevent elder abuse in family caregiving. It will assess the impact of the intervention on psychological elder abuse and quality of caregiving using modified scales and surveys.
What is being tested

Knowledge and Interpersonal Skills to Develop Enhanced Relationships

+ Healthy Living for the Caregiver
Behavioral
Who is being recruted

Elder Mistreatment
+2

+ Elder Abuse
+ Quality of Care
Over 18 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Placebo-Controlled
Phase 2
Interventional
Study Start: March 2026

See protocol details

Summary

Principal SponsorCase Western Reserve University
Study ContactKylie Meyer, PhD
Last updated: October 15, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: March 11, 2026Actual date on which the first participant was enrolled.

This study focuses on preventing psychological elder abuse in family caregiving situations, particularly for those caring for individuals living with dementia. The intervention, known as KINDER (Knowledge and Interpersonal Skills to Develop Enhanced Relationships), aims to improve the quality of caregiving by reducing stress in the caregiver-care recipient relationship and enhancing the caregiver's ability to handle challenges. This research is important as it seeks to address and prevent potential emotional harm to elderly individuals, ensuring they receive respectful and compassionate care from family members. Participants in the study will be part of a trial where they are randomly assigned to either receive the KINDER intervention or be part of a control group. The intervention focuses on building skills and knowledge that help caregivers manage their responsibilities more effectively. The study evaluates the impact of the intervention on reducing psychological harm, aiming to report on the effectiveness of the KINDER approach. Although specific risks or benefits are not detailed, the overall goal is to foster better caregiving environments and relationships.

Official TitleKnowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER): Testing the Efficacy of an Intervention to Prevent Psychological Elder Abuse in Family Caregiving 
Principal SponsorCase Western Reserve University
Study ContactKylie Meyer, PhD
Last updated: October 15, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
260 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants do not know which treatment they are receiving, but researchers do. This helps prevent bias from participants' expectations while still allowing researchers to monitor the study closely.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Elder Mistreatment
Elder Abuse
Quality of Care
Dementia
Caregiving
Criteria
6 inclusion criteria required to participate
Family member, including family of choice, to an individual living with AD/ADRD
Is aged 18 years or older
Provides 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

Show More Criteria

2 exclusion criteria prevent from participating
Sees the care recipient in-person less than 2 times per week
Has plans to place the care recipient in a skilled nursing facility within the next 8 months

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Experimental
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).
Group II
Placebo
Caregivers in the control arm will receive a workbook that covers 8 weeks of content focused on healthy living (e.g., nutrition).
Study Objectives
Primary Objectives

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.

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.
Secondary Objectives

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.

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.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Suspended
Case Western Reserve UniversityCleveland, United StatesSee the location
Recruiting soonOne Study Center