Black Resilient Caregivers

Not Applicable

Not yet recruiting

• Conditions: Obesity, Childhood
• Interventions: Behavioral: AARC

• Registration Number: NCT06458790
• Lead Sponsor: Duke University

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.

Study Timeline

• Status Verified: 2024-06
• Study First Submitted: 2024-06-06
• Study First Submitted QC: 2024-06-12
• Last Update Submitted: 2024-06-12
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Study Start: 2024-08-01
• Primary Completion: 2025-10-01
• Study Completion: 2025-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• Identify as African American/Black
• Expecting a child due Aug/Sept 2024
• Feel comfortable discussing personal experiences and asking questions in front of a group of peers
• Access to zoom, preferably with video
• Live in Durham
• Receive care at duke children's primary care
• Infant and mom home within 96 hours of birth

Read More

Exclusion Criteria

• Non English Speaking

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AARC Intervention	AARC	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 9 90 min sessions via zoom and in person.

Primary Outcome Measures

Name	Time	Method
Acceptability as measured by the Acceptability of Intervention Measure	9.5 months	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.
Semi-structured Interview	9.5 months	Semi-structured interview is measured by Qualitative Interview Questions that assess practicality, acceptability and appropriateness.
Feasibility as measured by the Acceptability of Intervention Measure	9.5 months	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

Secondary Outcome Measures

Name	Time	Method
Well child visit attendance	9 months	Number of well child visits missed during the 9 month intervention
Family Empowerment	2 months and 9.5 months	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.
Parenting Confidence	2 months and 9.5 months	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.
Parent stress	At baseline and 9.5 months	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.
Child Acute Care Utilization	Throughout the 9 month intervention	Number of unplanned hospitalizations

Trial Locations

Locations (1)

Duke University Health System; 🇺🇸 Durham, North Carolina, United States