KINDER Intervention for Elder Abuse in Dementia Caregivers

(KINDER Trial)

Overseen By Lauren Project Manager

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Case Western Reserve University

Disqualifiers: Sees recipient less than 2 times, plans nursing facility, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 5

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the KINDER program (Knowledge and Interpersonal Skills to Develop Enhanced Relationships) can assist family caregivers of people with dementia in reducing psychological elder abuse and improving caregiving quality. KINDER includes group discussions and self-paced lessons to help caregivers manage relationship stress and communicate better about challenging topics like balancing safety and independence. This trial suits family members who assist someone with dementia in daily tasks and provide at least four hours of care each day. As a Phase 2 trial, the research measures the program's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the KINDER program is generally easy for participants to handle. Earlier studies reported no major negative effects. The program's focus on group discussions and self-paced lessons is safe and suitable for caregivers, helping them manage stress and improve relationships with those they care for.

Since the KINDER program is in a Phase 2 trial, earlier research has already demonstrated some safety. This phase aims to reveal more about its effects and any possible issues. So far, results are promising, and participants have not experienced harmful side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the KINDER Intervention because it offers a fresh approach to addressing elder abuse among dementia caregivers by focusing on enhancing interpersonal relationships and communication skills. Unlike standard care options that might focus more on medical management or support services, KINDER involves interactive, facilitated group discussions and self-paced lessons, allowing caregivers to reflect on their behaviors and communication strategies. This method not only promotes a deeper understanding of the care recipient's vulnerabilities but also helps in navigating common conflicts, such as safety versus independence. By empowering caregivers with these tools, KINDER has the potential to improve the caregiver-care recipient relationship significantly.

What evidence suggests that the KINDER intervention is effective for reducing psychological elder abuse in dementia caregivers?

Research has shown that the KINDER program, which participants in this trial may receive, might help reduce emotional abuse of elderly people by family caregivers. Early studies suggest that KINDER's method, which includes group talks and self-paced lessons, is practical and may ease tension in relationships. The program aims to improve communication and understanding between caregivers and those they care for. Initial results indicate that KINDER can effectively prevent emotional mistreatment by boosting caregivers' skills and resourcefulness. Overall, the program seems promising in fostering healthier relationships between caregivers and those they support. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

The KINDER trial is for family caregivers aged 18 or older, helping someone with early to mid-stage dementia. Caregivers must assist with daily living activities for at least 4 hours a day and see the care recipient in-person at least twice a week. Those planning to move the care recipient into skilled nursing soon cannot participate.

Inclusion Criteria

Family member, including family of choice, to an individual living with AD/ADRD

I am 18 years old or older.

I am 65 years old or older.

Exclusion Criteria

Has plans to place the care recipient in a skilled nursing facility within the next 8 months

I see the person I care for less than twice a week in person.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

KINDER intervention consisting of three facilitated group discussion sessions over Zoom and self-paced lessons using a workbook

8 weeks

3 visits (virtual)

Follow-up

Participants are monitored for changes in psychological elder abuse, resourcefulness, social support, and other outcomes

24 weeks

Post-intervention surveys at 2, 12, and 24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Living for the Caregiver
• Knowledge and Interpersonal Skills to Develop Enhanced Relationships

Trial Overview KINDER aims to prevent elder abuse by reducing relationship strain and increasing caregiver resourcefulness through two approaches: 'Knowledge and Interpersonal Skills' training, and 'Healthy Living for the Caregiver'. Participants are randomly placed in one of these two groups.

How Is the Trial Designed?

Group I: KINDER Intervention Arm Experimental Treatment 1 Intervention

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: Control Condition Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Case Western Reserve University

Lead Sponsor

Trials

314

Recruited

236,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07216950

Knowledge and Interpersonal Skills to Develop Enhanced ... The goal of this two-arm, randomized control trial is to determine the efficacy of KINDER at mitigating psychological EA by family caregivers to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11689476/

FEASIBILITY AND PRELIMINARY EFFICACY OF THE ... Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER) is a psychoeducational intervention designed to prevent ...

3. patlynk.com patlynk.com/trial/NCT07216950

Intervention Test for Preventing Elder Abuse in Family ... This study focuses on preventing psychological elder abuse in family caregiving situations, particularly for those caring for individuals living with dementia.

4. tandfonline.com tandfonline.com/doi/abs/10.1080/08946566.2025.2460835

A feasibility study of KINDER: an elder mistreatment ... These findings suggest KINDER is a feasible low- to moderate-intensity intervention to prevent psychological mistreatment with AD/ADRD caregiving.

5. formative.jmir.org formative.jmir.org/2025/1/e73778/PDF

Acceptability of an Intervention to Prevent Older Adult ... care recipients. The Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER) intervention is among the first older adult mistreatment ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12351192/

Acceptability of an Intervention to Prevent Older Adult ... Psychological mistreatment is the most common form of older adult mistreatment by family caregivers and is known to create mental health ...

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/02/NCT05783102/Prot_SAP_000.pdf

Knowledge and Interpersonal Skills to Develop Exemplary ... the occurrence of verbal-type elder mistreatment by family caregivers to persons living with dementia. Content focuses on building healthy and respectful ...

8. researchgate.net researchgate.net/publication/387643931_FEASIBILITY_AND_PRELIMINARY_EFFICACY_OF_THE_KINDER_INTERVENTION_TO_PROMOTE_HEALTHY_CARE_RELATIONSHIPS

FEASIBILITY AND PRELIMINARY EFFICACY OF THE KINDER ... Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER) is a psychoeducational intervention designed to prevent emotional-type elder ...