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Clinical Trials/NCT06458790
NCT06458790
Completed
Not Applicable

African American Resilient Caregivers

Duke University1 site in 1 country44 target enrollmentSeptember 20, 2024
InterventionsAARC

Overview

Phase
Not Applicable
Intervention
AARC
Conditions
Obesity, Childhood
Sponsor
Duke University
Enrollment
44
Locations
1
Primary Endpoint
Acceptability as measured by the Acceptability of Intervention Measure
Status
Completed
Last Updated
3 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 20, 2024
End Date
November 25, 2025
Last Updated
3 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

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.

Intervention: AARC

Outcomes

Primary Outcomes

Acceptability as measured by the Acceptability of Intervention Measure

Time Frame: 7 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

Time Frame: 7 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

Time Frame: 7 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 Outcomes

  • Parenting Confidence(3 months and 6 months)
  • Parent stress(At baseline and 5 months)
  • GISCOMBE SUPERWOMAN SCHEMA (SWS) QUESTIONNAIRE(At baseline and 5 months)
  • Session Evaluation(1-7months)
  • Family Empowerment(3 months and 6 months)

Study Sites (1)

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