Knowledge and Interpersonal Skills to Develop Exemplary Relationships (KINDER)

November 8, 2023 updated by: Donna Benton, University of Southern California
This pilot study will test the effect of an online asynchronous psychoeducational intervention to improve relationship quality and prevent verbal-type elder mistreatment in caregiving dyads. The investigators will use a pre-post test design to test the feasibility and acceptability of this video-based intervention, and to determine the likelihood that participation in this program may improve caregiver relationship quality.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
23

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90007
        • University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Provides assistance to someone over the age of 60 with an illness or a disability ("care recipient") who requires personal assistance from another person (e.g., bathing, preparing meals). (Assistance provided with at least 1 activity of daily living and/or at least 2 instrumental activities of daily living.)
  • Person receiving care from the study participant has a cognitive impairment. This does not have to be diagnosed.
  • Participant provides at least 8 hours of assistance to the care recipient per week
  • Participant does not intend to place the care recipient in a skilled nursing facility or assisted living facility within 3 months of consenting into the study

Exclusion Criteria:

  • Does not read and speak English
  • Cannot access a computer and internet (needed to complete lessons)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: KINDER Participant
The intervention will be provided with a 8-part psychoeducational intervention delivered online on a weekly basis. Online modules will be comprised of a short (approximately 3 minute) videos followed by more specific text-based information and links to additional resources. At the end of the module, participants will complete a short quiz, followed by a reflection exercise to reinforce learning. Each model, participants will be asked to select a goal to complete a pleasurable activity and receive an option to set a text or email reminder to do so.
Behavioral: KINDER
KINDER is an online course for people assisting an older adult with dementia. It is intended to improve the quality of caregiver's relationship with the care recipient and reduce the chance of risky relationship behavior (e.g., yelling). Courses will cover topics including understanding cognitive impairments, navigating evolving roles, and dealing with frustration. During this course, participants will learn skills to deal with difficult situations caregivers frequently encounter in ways that support a healthy caregiving relationship. Videos will be story-based and represent different types of caregiving relationships and challenges encountered.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in frequency of verbal mistreatment
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.
This scale will measure frequency of verbal mistreatment using a measure based on the Conflict Tactics Scale (Straus et al., 1996), with additional questions from other items (Acierno et al., 2010; Beach et al., 2005; Conrad et al., 2011; Deliema et al., 2012)
This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.
Change in the number of positive aspects of the relationship with the care recipient (Dyadic Relationship Scale)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.
Participants are asked how much they agree with positive statements about their relationship with the care receiver on a 0 to 3 scale. This item comes from Sebern & Whitlatch (2007)
This measure will be asked immediately before the intervention, immediately after the intervention, and 2 months after the intervention is complete. The question asks participants about events in the previous 2 months.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in caregiver competence (Caregiving Competence Scale)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
We will use the Caregiving Competence Scale developed by Pearlin and colleagues (1990)
This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
Change in perceived stress (Perceived Stress Scale)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
We will use the Perceived Stress Scale developed by Cohen & Williamson (1988)
This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
Change in caregiver burden (Zarit Burden Index)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
We will use the Zarit Burden Index developed by Zarit and colleagues (1980)
This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
Change in depression (Patient Health Questionnaire-9)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
We will use the Patient Health Questionnaire-9 (Kroenke et al., 2001)
This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
Change in caregiver mastery (Caregiver Mastery Scale)
Time Frame: This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.
We will use the Caregiver Mastery Scale developed by Pearlin & Schooler (1978)
This measure will be asked immediately before the intervention, immediately after the intervention, and 3 months after the intervention is complete. The question asks participants about events in the previous 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Archstone Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Donna Benton, PhD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 8, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 9, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KINDER 18-01-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Only de-identified participant data will be available to other researchers at the end of our study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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