NCT03584568

Brief Summary

It is hypothesized that reappraising intergeneration relationships through perspective-taking will enhance the well-being of adult-child caregivers. Incorporating both psychological and social perspectives, the study makes a unique contribution to address research gaps by evaluating an integrated model of intervention for dementia caregivers. The conceptual model involves the following components: 1) relational insights; 2) self-reflection to integrate the challenges and benefits in caregiving; 3) interpersonal empathy To test the incremental value of perspective-taking reappraisals, the study involves a two-arm randomized controlled trial of 12 weeks of intervention with two conditions: 1) Reappraisal through Perspective Taking and 2) Basic Skill Building. Telephone-administered sessions are integrated with group sessions and home visits to maximize sustainability and accessibility of the intervention. One hundred fifty-four participants will be recruited and randomized. Primary outcomes are reduced depressive symptoms and enhanced psychological well-being for the caregivers. Secondary outcomes include enhanced social support for caregivers and reduced behavioral problems in the care-recipients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2018

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 12, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 11, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2021

Completed
Last Updated

December 14, 2018

Status Verified

December 1, 2018

Enrollment Period

2.7 years

First QC Date

June 28, 2018

Last Update Submit

December 12, 2018

Conditions

Keywords

CaregivingIntergenerationReappraisal through perspective taking

Outcome Measures

Primary Outcomes (2)

  • Change in Center for Epidemiological Studies-Depression Search Results Center for Epidemiological Studies Depression

    20-item measure that asks caregivers to rate how often over the past week they The scale rates experienced symptoms associated with depression.. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater level of having depressive symptoms.

    Week 1, 6, 12, 24

  • Change in Ryff's Psychological Well-being

    The 18-version of the scale taps the six areas of psychological well-being: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance. Respondents rate statements on a scale of 1 to 6, with 1 indicating strong disagreement and 6 indicating strong agreement. The range of scores is from 0 to 108. Higher scores suggest higher levels of well-being. The subscale score of each of the six areas can be calculating by summation of the three items associated with each of the area.

    Weeks 1,6, 12, 24

Secondary Outcomes (2)

  • Change in Revised Memory and Problem Checklist

    Weeks 1, 6, 12 ,24

  • Change in MacArther Social Support Scales

    Weeks 1,6, 12, 24

Study Arms (2)

Perspective Taking Reappraisal

EXPERIMENTAL

This arm focuses on reappraisals with perspective taking with a limited amount of basic skill building

Behavioral: Perspective Taking ReappraisalOther: Basic Skill Building

Basic Skill Building

OTHER

This arm focuses on basic skill building only.

Other: Basic Skill Building

Interventions

Interventions involving 1) appreciating relational insights; 2) enhancing self-awareness; 3) empathetic understanding of care-recipient; 4) integrating self-care and caring for others and 5) negotiation.

Perspective Taking Reappraisal

These skill-building exercises are commonly used in psycho-education programs for caregivers:monitoring mood and activities, relaxation techniques and scheduling pleasant events, basic communication with the care recipient, communicating the caregivers' own needs with other family member or related persons including helpers and professional staff.

Basic Skill BuildingPerspective Taking Reappraisal

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Primary caregivers aged 20 or older and who have been caring for persons (aged 60 or above) with a physician diagnosis of Alzheimer's disease in the mild to moderate range as determined by the Clinical Dementia Rating Scale.
  • Primary caregivers who have been providing unpaid care for more than 12 hours a week for at least the past three months.
  • The care should involve day-to-day decision-making as well as any of the following: feeding, dressing, bathing, toileting, housework, preparing meals, medication and handling finances.
  • They can be daughter/son or daughter-/son-in-law of the care recipient.

You may not qualify if:

  • signs of severe intellectual deficits
  • demonstrated suicidal ideation
  • exhibited evidence of psychotic disorders
  • hearing/ visual impairment
  • inability to read or speak Chinese/Cantonese fluently and severe.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Applied Social Sciences, Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Institute of Active Ageing

Kowloon, Hong Kong

RECRUITING

Related Publications (1)

  • Au A, Gallagher-Thompson D, Wong MK, Leung J, Chan WC, Chan CC, Lu HJ, Lai MK, Chan K. Behavioral activation for dementia caregivers: scheduling pleasant events and enhancing communications. Clin Interv Aging. 2015 Mar 26;10:611-9. doi: 10.2147/CIA.S72348. eCollection 2015.

    PMID: 25848237BACKGROUND

Related Links

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Alma Au, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joey Chan, Master

CONTACT

Wing-sze Chan, Master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 12, 2018

Study Start

November 11, 2018

Primary Completion

July 8, 2021

Study Completion

July 8, 2021

Last Updated

December 14, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations