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Black Resilient Caregivers

African American Resilient Caregivers

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06458790
Acronym
AARC
Enrollment
44
Registered
2024-06-14
Start date
2024-09-20
Completion date
2025-11-25
Last updated
2026-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Childhood

Brief summary

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

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.

Interventions

BEHAVIORALAARC

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.

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Acceptability as measured by the Acceptability of Intervention Measure7 monthsAcceptability 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.
Feasibility as measured by the Acceptability of Intervention Measure7 monthsAcceptability 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
Semi-structured Interview7 monthsSemi-structured interview is measured by Qualitative Interview Questions that assess practicality, acceptability and appropriateness.

Secondary

MeasureTime frameDescription
Parenting Confidence3 months and 6 monthsMeasured 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.
Parent stressAt baseline and 5 monthsMeasured 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.
Family Empowerment3 months and 6 monthsMeasured 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.
GISCOMBE SUPERWOMAN SCHEMA (SWS) QUESTIONNAIREAt baseline and 5 monthsMeasured 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
Session Evaluation1-7monthsSession Evaluation(modified) uses the following scale: Strongly disagree / Disagree / Agree / Strongly agree. The more participants agree or completely agree, the better the outcome

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMichelle White, MD/MPH

Duke Health

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026