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

Overview

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.

Full Title of Study: “SoCal Savvy: Testing Savvy Caregiver in a Racially and Ethnically Diverse Sample in”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2024

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.

Interventions

  • Behavioral: Group sessions over 3 weeks
    • Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.
  • Behavioral: Group sessions over 6 weeks
    • Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.

Arms, Groups and Cohorts

  • Active Comparator: Savvy Caregiver Program
    • Savvy Caregiver Program, 6 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.
  • Active Comparator: Savvy Express
    • Savvy Express, 3 weekly sessions, group treatment, addressing educational, informational, and psychosocial issues and community resources.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Southern California
  • Provider of Information About this Clinical Study
    • Principal Investigator: Maria P. Aranda, Associate Professor – University of Southern California
  • Overall Contact(s)
    • Maria P Aranda, 2137401887, aranda@usc.edu

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