Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)

NCT07216950 | Not Yet Recruiting DMC

• 1 other identifier: STUDY20250080
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention

Secondary Outcomes (2)

• Resourcefulness

  Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention

• Caregiving Relationship Strain

  Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention

Other Outcomes (3)

• Other Types of Elder Abuse

  Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention

• Depressive Cognitions

  Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention

• Social Support

  Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention

Study Arms (2)

KINDER Intervention Arm

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).

Behavioral: Knowledge and Interpersonal Skills to Develop Enhanced Relationships

Control Condition

PLACEBO COMPARATOR

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

Knowledge and Interpersonal Skills to Develop Enhanced Relationships BEHAVIORAL

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).

KINDER Intervention Arm

Healthy Living for the Caregiver BEHAVIORAL

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

Control Condition

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• The care recipient is at least age 65 or older
• The care recipient has early or mid-stage AD/ADRD, as indicated by a score of 4 to 6 on the Functional Assessment Staging Tool (FAST Scale)

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Western Reserve University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Kylie Meyer, PhD

CONTACT

2163681928; knm77@case.edu

Lauren Project Manager

CONTACT

2163681928; ltj15@case.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 12, 2025
• First Posted: October 15, 2025
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): November 11, 2028
• Study Completion (Estimated): May 11, 2029
• Last Updated: May 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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

Locations

US (1)