Elder MistreatmentKINDERNCT07216950
Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER)
A study testing Knowledge and Interpersonal Skills to Develop Enhanced Relationships and Healthy Living for the Caregiver in people with Elder Mistreatment and Elder Abuse, run by Case Western Reserve University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Elder Mistreatment, Elder Abuse, Quality of Care
- What is being tested?
- Knowledge and Interpersonal Skills to Develop Enhanced Relationships and Healthy Living for the Caregiver
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 260 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Dec 2026to 15 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Case Western Reserve University
Cleveland, Ohio, 44106
Kylie Principal Investigator, 216-368-1928, knm77@case.edu
About this study
Official title: Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER): Testing the Efficacy of an Intervention to Prevent Psychological Elder Abuse in Family Caregiving
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
- Being tested
- Knowledge and Interpersonal Skills to Develop Enhanced Relationships, Healthy Living for the Caregiver
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Knowledge and Interpersonal Skills to Develop Enhanced RelationshipsBehavioural
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).
Healthy Living for the CaregiverBehavioural
Caregivers in the control arm will receive a workbook that covers 8 weeks of content focused on healthy living (e.g., nutrition).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: Behavioral: Healthy Living for the Caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Secondary outcomes (2)
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.
Measured: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
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.
Measured: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2025
- Study start15 Dec 2026 (estimated)
- Primary completion15 Jun 2029 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elder MistreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kylie Meyer, Case Western Reserve University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07216950
- Sponsor's protocol ID
- STUDY20250080
- Acronym
- KINDER
- Status last verified
- Sep 2026
- First submitted
- 12 Oct 2025
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Baseline and follow up surveys with participants; Referral, screening, enrollment, and retention data; Fidelity surveys. All data will be de-identified.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge and Interpersonal Skills to Develop Enhanced Relationships (KINDER): Testing the Efficacy of an Intervention to Prevent Psychological Elder Abuse in Family Caregiving
- ClinicalTrials.gov ID
- NCT07216950
- Acronym / sponsor ID
- KINDER / STUDY20250080
- Conditions
- Elder Mistreatment, Elder Abuse, Quality of Care, Dementia, Caregiving
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 15 Dec 2026 (estimated)
- Primary completion
- 15 Jun 2029 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 15 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KINDER Intervention Arm | Experimental | Behavioral: Knowledge and Interpersonal Skills to Develop Enhanced RelationshipsKINDER 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 | Placebo comparator | Behavioral: Healthy Living for the CaregiverCaregivers in the control arm will receive a workbook that covers 8 weeks of content focused on healthy living (e.g., nutrition). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Knowledge and Interpersonal Skills to Develop Enhanced RelationshipsKINDER 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). | Behavioural | KINDER Intervention Arm |
| Healthy Living for the CaregiverCaregivers in the control arm will receive a workbook that covers 8 weeks of content focused on healthy living (e.g., nutrition). | Behavioural | Control Condition |
Primary outcome
Psychological Elder Abuse
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
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.
Quality of Caregiving
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
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.
2 secondary outcomes
Resourcefulness
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Caregiving Relationship Strain
Time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: Yes. Baseline and follow up surveys with participants; Referral, screening, enrollment, and retention data; Fidelity surveys. All data will be de-identified.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Knowledge and Interpersonal Skills to Develop Enhanced Relationships and Healthy Living for the Caregiver in people with Elder Mistreatment and Elder Abuse, run by Case Western Reserve University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kylie Meyer, PhD (2163681928, knm77@case.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological Elder Abuse (time frame: Baseline, 2 weeks post-intervention, 12 weeks post-intervention, 24 weeks post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.