SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in Southern California (SoCalSavvy)

SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in

The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months.

Study Overview

• Status: Recruiting
• Conditions: Psychological Distress; Caregiver Burnout
• Intervention / Treatment: Behavioral: Group sessions over 6 weeks; Behavioral: Group sessions over 3 weeks

Detailed Description

A number of epidemiological studies, systematic reviews, and consensus reports highlight the importance of non-pharmacological, sociobehavioural interventions to address the health, psychological, and social effects of caregiving for persons living with dementia, and the need for tangible information and resources.

The investigators will conduct a hybrid efficacy-effectiveness trial intended to address these gaps by testing the efficacy-effectiveness of two multi-family group interventions, and on 250 English-speaking adults: Savvy Caregiver Express™ (3-session, newly piloted in Los Angeles County for feasibility) and Savvy Caregiver Program (original 6-session evidenced-based intervention), across post-intervention, 3- and 6-months. It is hypothesized that no differences (comparable effects) between the programs in their efficacy/effectiveness and moderating conditions.

Focus groups (~25 participants) will be conducted to ascertain program acceptability and satisfaction.

The analyses will include a multiple linear mixed-effects modeling for our trial outcomes, and thematic analyses for our focus group interview data.

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maria P Aranda; Phone Number: 2137401887; Email: aranda@usc.edu
• Study Contact Backup: Name: Iris Aguilar; Phone Number: 2137401887; Email: iaguilar@usc.edu

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90015
      • Recruiting
      • University of Southern California
      • Contact: Maria P Aranda, PhD; Phone Number: 213-740-1887; Email: aranda@usc.edu

Participation Criteria

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:

• English- speaking women and men age 18 or older who care for or provide assistance to someone with dementia

Exclusion Criteria:

• Caregivers who have sensory or physical conditions that interfere with participation in an on-site, group-administered activity

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Savvy Caregiver Program; Savvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.	Behavioral: Group sessions over 6 weeks; Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.
Active Comparator: Savvy Express; Savvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.	Behavioral: Group sessions over 3 weeks; Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	caregiver depressive symptoms	up to 7 months
Generalized Anxiety Disorder (GAD-7)	caregiver anxiety symptoms	up to 7 months
Revised Memory and Behavior Problems Checklist (RMBPC)	caregiver reactivity to family member's memory/behavior problems	up to 7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Competence Scales	measures caregiver skills, mastery, competence, management of the situation based on the Caregiver Competence, Management and Meaning Scales	up to 7 months
Medical Outcomes Study Social Support Survey (MOS)	Measures caregiver social support using the MOS scale	up to 7 months
Intent to Institutionalize	TA one-item measure that assesses if the caregiver intends to institutionalize the family member in the next 6 months	up to 7 months
Family Members Activities of Daily Living (ADL)	measures family member's activities of daily living using the Katz ADL scale	up to 7 months
Family Members Instrumental Activities of Daily Living (IADL)	measures family member's activities of daily living using the Lawton IDL scale	up to 7 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Caregiver Satisfaction	This is a measure developed for this specific study to ascertain the study participant's satisfaction with the intervention itself.	up to 7 months

Collaborators and Investigators

• Sponsor: University of Southern California

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2020
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: June 2, 2020
• First Submitted That Met QC Criteria: June 4, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Caregiver Burden
• Other Study ID Numbers: 5356000538

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No