Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)

NCT ID: NCT07216950

Last Updated: 2025-10-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-11
• Study Completion Date: 2029-05-11

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; Quality of Care; Dementia; Caregiving

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Knowledge and Interpersonal Skills to Develop Enhanced Relationships

Intervention Type: 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).

Control Condition

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

Group Type: PLACEBO_COMPARATOR

Healthy Living for the Caregiver

Intervention Type: BEHAVIORAL

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

Interventions

Knowledge 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).

Intervention Type: BEHAVIORAL

Healthy 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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 Global Deterioration Scale

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: lead

Responsible Party

Kylie Meyer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Case Western Reserve University

Cleveland, Ohio, United States

Countries

United States

Central Contacts

Kylie Meyer, PhD

Role: CONTACT

knm77@case.edu

2163681928

Lauren Project Manager

Role: CONTACT

ltj15@case.edu

2163681928

Facility Contacts

Kylie Principal Investigator

Role: primary

knm77@case.edu

2163681928

Other Identifiers

STUDY20250080

Identifier Type: -

Identifier Source: org_study_id