Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT05098652

Coaching Dementia Caregivers to Master Care-Resistant Behavior

266 family caregivers will be randomly assigned to either immediate intervention or delayed intervention groups. All caregivers will complete baseline surveys and 3 weeks of daily diaries. The immediate intervention group will receive 12 weeks of CuRB-IT. They will complete 3 rounds of 3-week daily diaries followed by an intermittent survey at 12 week intervals for the next 33 weeks. The delayed intervention group will receive 12 weeks of attention, complete 1 round of 3-week daily diaries followed by an intermittent survey, then complete 12 weeks of CuRB-IT, and complete 2 rounds of 3--week daily diaries followed by an intermittent survey at 12-week intervals for the next 18 weeks.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Care-resistant Behavior Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders

Age range

18 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35244, United States

About this study

The purposes of the delayed-intervention randomized clinical trial (N=266) are to:

Care-Resistant Behavior Internet Training (CuRB-IT).

  • examine the efficacy of CuRB-IT in increasing the self-efficacy of family caregivers of persons living with dementia to handle care-resistant behaviors (CRB);
  • further test the efficacy of CuRB-IT in improving caregivers coping strategies (a) among the experimental (immediate-intervention group) as compared to the control (delayed-intervention group) (between groups) and (b) within-person from pre- to post- intervention;
  • examine intervention decay at 3- and 6-months post intervention to determine performance of intervention and inform scheduling of booster sessions;
  • assess the efficacy of the CuRB-IT intervention in preventing onset of poor coping strategies by family caregivers;
  • test the hypothesized mechanism of action that increased CRB self-efficacy and use of CuRB-IT problem-focused coping strategies mediate the relationship between CRB stress appraisal and caregiving activities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1)Caregiver of any race or gender who is aged >18 years
  • 2) provides unpaid care,
  • 3) cares for a spouse/common-law, sibling, parent or grandparent (or in-law, aged 60+ years),
  • 4) lives with or shares cooking facilities with the care recipient,
  • 5) Care recipient has mild cognitive impairment or dementia as identified using the Quick Dementia Rating System instrument,
  • 6) the care provided consists of help with at least 2 Instrumental Activities of Daily Living or one Activity of Daily Living,
  • 7) the care recipient is resistant to receiving assistance with, or refuses to do, at least one instrumental or activity of daily living

Exclusion criteria

  • 1) persons who cannot speak/read English
  • 2) who do not have reliable access to a smart phone or internet

Treatment and study plan

CuRB-IT

Behavioral

9 1-hour coaching sessions delivered over a videoconferencing platform (Zoom); 6 delivered weekly, 3 delivered biweekly

Primary outcomes

  1. Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers

    Time frame: Daily during weeks 1, 2, and 3

    Experimental and control

  2. Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers

    Time frame: Daily during weeks 15, 16, and 17

    Experimental and control

  3. Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers

    Time frame: Daily during weeks 37, 38, and 39

    Experimental and control

  4. Change in frequency of care-resistant behaviors and other dementia-related behaviors measured by a 19-item self-report scale (yes/no) for dementia family caregivers

    Time frame: Daily during weeks 49, 50, and 51

    Experimental and control

  5. Change in caregiver responses to dementia-related behaviors

    Time frame: Immediately after enrollment

    Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).

  6. Change in caregiver responses to dementia-related behaviors

    Time frame: Once at week 15

    Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).

  7. Change in caregiver responses to dementia-related behaviors

    Time frame: Once at week 37

    Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).

  8. Change in caregiver responses to dementia-related behaviors

    Time frame: Once at week 49

    Experimental (immediate) and control (delayed intervention). Measured using yes/no responses to 8 items (2 from the Conflicts Tactics Scale Revised, 2 from the Conflicts Tactics Scale modified for Older Adults, and 4 from the Conflict Tactics Scale for Child Mistreatment).

  9. Change in caregiver self-efficacy coping skills

    Time frame: Immediately after enrollment

    Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.

  10. Change in caregiver self-efficacy coping skills

    Time frame: Once at week 15

    Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.

  11. Change in caregiver self-efficacy coping skills

    Time frame: Once at week 37

    Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.

  12. Change in caregiver self-efficacy coping skills

    Time frame: Once at week 49

    Experimental (immediate) and control (delayed intervention). Measured using 14 items from the Brief Coping Scale.

  13. Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist

    Time frame: Once at week 15

    Experimental (immediate)

  14. Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist

    Time frame: Once at week 37

    Experimental (immediate)

  15. Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist

    Time frame: Once at week 49

    Experimental (immediate)

  16. Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist

    Time frame: Once at week 37

    Control (delayed)

  17. Change in caregiver self-efficacy measured by selection of items from 10-item CurB-CuRB-IT Strategy checklist

    Time frame: Once at week 49

    Control (delayed)

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Coaching Dementia Caregivers to Master Care-Resistant Behavior and Improve Coping Strategies

Acronym: CuRB-IT

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Oct 28, 2021
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.