Black Resilient Caregivers (AARC)

African American Resilient Caregivers

To determine the feasibility of an intervention to promote the physical and socioemotional health of African American (AA) families.

Study Overview

• Status: Completed
• Conditions: Obesity, Childhood
• Intervention / Treatment: Behavioral: AARC

Detailed Description

AA parents face unique racialized stressors which negatively impact their health and the health of their children. This heavy burden of chronic stress contributes to a high prevalence of anxiety and depression in AA parents. Parent stress negatively impacts child development and family health behaviors including diet and physical activity. A culturally-tailored intervention that addresses both AA parent stress and early childhood health and development has the potential to be more effective in promoting healthy family behaviors and AA parent mental health than traditional early childhood preventive care. Guided by AA parents and community members, the investigators propose to systematically co-develop a novel intervention using two frameworks: Centering and Superwoman Schema. The novel intervention will include group parent support, training in stress management and links to relevant community resources. The investigators will then determine the feasibility, acceptability, and limited efficacy of the adapted intervention in a pilot study.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Identify as African American/Black
• Expecting a child due September, October or November 2024
• Feel comfortable discussing personal experiences and asking questions in front of a group of peers
• Access to zoom, preferably with video
• Live in North Carolina
• Infant and mom home within 96 hours of birth

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: AARC Intervention; This intervention will adapt an already-existing evidence-based Centering Parenting program. Investigators will not provide clinical care to participants. Investigators will also address topics that are specific to African American families. Investigators will conduct 7 90 min sessions via zoom and in person.

Behavioral: AARC; This intervention will adapt an already-existing evidence-based Centering Parenting program addressing topics that are specific to African American families. There will be 7 90 min sessions via zoom. Group education topics include (parenting goals, infant feeding and sleep, self-care). Participants will complete surveys and interviews at various times to evaluate the program. The survey topics will include: parent stress, parent confidence and thoughts about the intervention. Surveys will be completed independently by participants online via redcap at a time that is convenient to them; if requested, the coordinator may complete the survey with the participant directly by phone /zoom. Interviews will be completed with a coordinator via zoom/phone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability as measured by the Acceptability of Intervention Measure	Acceptability of Intervention Measure (modified) uses the following scale: Completely disagree / Disagree / Neither agree nor disagree / Agree / Completely agree. The more participants agree or completely agree, the better the outcome.	7 months
Feasibility as measured by the Acceptability of Intervention Measure	Acceptability of Intervention Measure - Feasibility (modified) uses the following scale: Completely disagree / Disagree / Neither agree nor disagree / Agree / Completely agree. The more participants agree or completely agree, the better the outcome	7 months
Semi-structured Interview	Semi-structured interview is measured by Qualitative Interview Questions that assess practicality, acceptability and appropriateness.	7 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Parenting Confidence	Measured via Karitane Parenting Confidence Scale. Each item on the Karitane Parenting Confidence Scale is scored 0, 1, 2, or 3. There are no reverse-scored items and items have a common scoring order. That is, for each item the first response is scored 0, the second 1, and so on. Items marked not applicable are scored 2. Scores are then summed to give a total score (range = 0-45). The higher the range the better the outcome.	3 months and 6 months
Parent stress	Measured via perceived stress scale. Perceived Stress Scale score by following these directions: First, reverse the scores for questions 4, 5, 7, and 8. On these 4 questions, change the scores like• this: 0 = 4, 1 = 3, 2 = 2, 3 = 1, 4 = 0. Now add up the scores for each item to get a total. Individual scores on the Perceived Stress Scale can range from 0 to 40 with higher scores indicating higher perceived stress.; Scores ranging from 0-13 would be considered low stress.; Scores ranging from 14-26 would be considered moderate stress.; Scores ranging from 27-40 would be considered high perceived stress.	At baseline and 5 months
Family Empowerment	Measured via the Family Empowerment Scale This measures scores for the subscales are simple means. Calculate the mean for each subscale by adding the scores for the subscale items that have NOT been answered "Not Applicable," and dividing by the number of questions that were answered "Never…Very Often" (1 through 5). If there are missing items (up to 3) in responses 1-5, add the scores for the subscale items, and divide by the number of answered questions. Add responses to all of the subscales for an overall score but be aware that each of the subscales addresses quite a different topic (Family, Service System, Community). Many published articles have employed the method of adding all items for an overall score. Examining each subscale score in relation to other variables of interest is another approach that may yield more specific information.	3 months and 6 months
GISCOMBE SUPERWOMAN SCHEMA (SWS) QUESTIONNAIRE	Measured via average scores for each SWS subscale. RESPONSE VALUE This is NOT TRUE for me 0 This is TRUE for me RARELY 1 This is TRUE for me SOMETIMES 2 This is TRUE for me ALL THE TIME 3 If SWS subscale items are summed to create one SWS total, these categories can be used: 0-35: Low SWS 36-70: Moderate SWS 71-105: High SWS Subscales: Strength (6 items): 0-6 Low 7-12 Moderate 13-18 High Suppress (7 items): 0-7 Low 8-14 Moderate 15-21 High Resistance (7 items): 0-7 Low 8-14 Moderate 15-21 High Motivation (6 items): 0-6 Low 7-12 Moderate 13-18 High Help (9 items): 0-9 Low 10-18 Moderate 19-27 High SWS appraisal items should be averaged. RESPONSE VALUE This bothers me NOT AT ALL 0 This bothers me SOMEWHAT 1 This bothers me VERY MUCH 2	At baseline and 5 months
Session Evaluation	Session Evaluation(modified) uses the following scale: Strongly disagree / Disagree / Agree / Strongly agree. The more participants agree or completely agree, the better the outcome	1-7months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: Duke Pediatrics, Children's Health and Discovery Initiative
• Investigators: Principal Investigator: Michelle White, MD/MPH, Duke Health

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2024
• Primary Completion (Actual): November 25, 2025
• Study Completion (Actual): November 25, 2025

Study Registration Dates

• First Submitted: June 6, 2024
• First Submitted That Met QC Criteria: June 12, 2024
• First Posted (Actual): June 14, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Pediatric Obesity
• Other Study ID Numbers: Pro00111805_1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: If we plan to share with other researchers in the future, we will submit an amendment to the IRB.

Drug and device information, study documents

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