Black Resilient Caregivers

Obesity, Childhood Clinical Trial

— AARC  

Official title:

African American Resilient Caregivers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06458790
• Other study ID #: Pro00111805_1
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: Duke University
• Contact: Javier Rodriguez, as
• Phone: 919-620-4732
• Email: javier.rodriguez2[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Non English Speaking

Related Conditions & MeSH terms

• Obesity, Childhood
• Pediatric Obesity

Intervention

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 9 90 min sessions via zoom and in person. 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.

Locations

Country	Name	City	State
United States	Duke University Health System	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	Duke Pediatrics, Children's Health and Discovery Initiative

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9.5 months
Primary	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	9.5 months
Primary	Semi-structured Interview	Semi-structured interview is measured by Qualitative Interview Questions that assess practicality, acceptability and appropriateness.	9.5 months
Secondary	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.	2 months and 9.5 months
Secondary	Well child visit attendance	Number of well child visits missed during the 9 month intervention	9 months
Secondary	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 9.5 months
Secondary	Child Acute Care Utilization	Number of Emergency Department visits	Throughout the 9 month intervention
Secondary	Child Acute Care Utilization	Number of unplanned hospitalizations	Throughout the 9 month intervention
Secondary	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.	2 months and 9.5 months