Life Enhancing Activities for Family Caregivers (LEAF)

August 1, 2019 updated by: Glenna Dowling, University of California, San Francisco

Life Enhancing Activities for Family Caregivers (LEAF)

Life Enhancing Activities for Family Caregivers is a six-week program designed to increase positive affect in people who care for a family member with dementia. The intervention consists of 6 weekly one-hour sessions conducted one-on-one with a trained facilitator to teach simple skills that are practiced at home in a study-supplied workbook. The program is preceded and followed by a 30-45 minute questionnaire. Follow-up assessments will be conducted at 1-month, 3-months, and 6-months post intervention.

Primary hypothesis is that experimental subjects who participate in LEAF will demonstrate significantly greater improvements in psychological outcomes and will engage in more problem focused and positive appraisal forms of coping compared to the wait-list control condition.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

All study activities can be conducted from the participant's home, making participation possible for any qualified caregiver with computer and wifi access, in any U.S. state. The LEAF study will supply the tablet computer, software, and workbook required for participation.

Study Type

Interventional

Enrollment (Actual)

175

Phase

  • 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
      • San Francisco, California, United States, 94143
        • UCSF

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants must be able to be defined as the primary care provider for a family member with dementia. (Person with dementia must live with the caregiver or in their own home and not in a care facility.)
  • Must speak and read English
  • Must have the ability to provide informed consent

Exclusion Criteria:

  • Lack of access to a high speed internet connection
  • Evidence of severe cognitive impairment or active psychosis, as assessed by trained interviewers

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: positive affect intervention
Behavioral: Positive Affect
Six-session skill-building program designed to raise levels of positive emotion when skills are practiced over the duration of the program.
Other Names:
  • Life Enhancing Activities for Family Caregivers (LEAF)
No Intervention: wait list control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Repeated measures of the modified version of the Differential Emotions Scale (DES) (Izard, 1977)
Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post
The DES will be used to assess positive and negative affect. This 20-item version of the DES was modified to include additional positive affect items as well as those that are likely to tap into trait positive affectivity. The full scale assesses interest, enjoyment, surprise, sadness, anger, disgust, contempt, fear, guilt, shame, shyness, amusement, awe, contentment, gratitude, hope, love, pride, sympathy, and sexual feelings (e.g., "I felt sexual, desiring, and flirtatious"). The scale can be scored for total positive and negative affect,grouped according to where they would fall on the circumplex model of affect (e.g., high activation vs. lower activation),or individual affects can be examined. In student samples this modified DES has shown acceptable reliability with the positive affects subscale (α = .79) and the negative affects subscale (α = .69).
Baseline and weeks 6 and 10; 3-months and 6-months post

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in burden at end of intervention, 3 and 6-months post - Zarit Burden Inventory (Zarit, Reever, & Bach-Peterson, 1980)
Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post
22-item inventory assesses caregivers' subjective feelings of the impact of caregiving on emotional and physical health functioning, social life, and financial status.
Baseline and weeks 6 and 10; 3-months and 6-months post
Change in perceived stress at end of intervention, 3 and 6-months post - Perceived Stress Scale (PSS) (Cohen, 1988)
Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post
The 10 items are designed to identify how unpredictable, uncontrollable and overloaded respondents find their lives. Scores range from 0-40, with higher scores indicating greater stress.
Baseline and weeks 6 and 10; 3-months and 6-months post
Change in caregiver strain at end of intervention, 3 and 6-months post - Caregiver Strain Index (CSI) (Robinson, 1983)
Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post
The CSI is a 13-item measure of both objective and subjective elements of caregiver strain.
Baseline and weeks 6 and 10; 3-months and 6-months post
Change in depression at end of intervention, 3 and 6-months post - Depression, Patient Reported Outcomes Measurement Information System Item Bank, v. 1.0 (PROMIS; Cella et al., 2010)
Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post
Used to assess depressive mood.
Baseline and weeks 6 and 10; 3-months and 6-months post
Change in anxiety at end of intervention, 3 and 6-months post - Emotional Distress - Anxiety, PROMIS Item Bank v. 1.0 (Cella et al., 2010)
Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post
Used to assess anxiety.
Baseline and weeks 6 and 10; 3-months and 6-months post
Change in coping at end of intervention, 3 and 6-months post - Ways of Coping Scale (Folkman, Lazarus, Pimley, & Novacek, 1987)
Time Frame: Baseline and weeks 6 and 10; 3-months and 6-months post
The 23 forms of coping responses assessed include: confrontive coping, escape-avoidance, planful problem-solving, positive reappraisal, benefit, growth, mastery of stress, other success, purpose, positive relations with others, religion, and respite, benevolent and negative religious coping, emotional processing and expression, goal replacement, and maintaining optimism.
Baseline and weeks 6 and 10; 3-months and 6-months post

Collaborators and Investigators

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

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Glenna A Dowling, PhD, University of California, San Francisco

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

October 1, 2013

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

June 30, 2019

Study Registration Dates

First Submitted

March 25, 2013

First Submitted That Met QC Criteria

April 1, 2013

First Posted (Estimate)

April 8, 2013

Study Record Updates

Last Update Posted (Actual)

August 5, 2019

Last Update Submitted That Met QC Criteria

August 1, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-13236
  • A115168 (Other Grant/Funding Number: Atlantic Philanthropies)

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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