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Clinical Trials/NCT07009795
NCT07009795CompletedNot Applicable

Rise & Renew (Remembering, Expressing, Navigating, Embracing, Witnessing): Enhancing Well-being Among Black Women Who've Experienced a First-order Bereavement Event

Lillian Haley, PhD1 site in 1 country30 target enrollmentStarted: May 20, 2025Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
30
Locations
1
Primary Endpoint
Feasibility of Intervention Measure (FIM)

Study Overview

Brief Summary

This study is testing a new grief support program called Rise & Renew (Remembering, Expressing, Navigating, Embracing, Witnessing) designed for Black women ages 40 and older who have experienced the loss of a close loved one, such as a spouse or significant other, parent, or child (including pregnancies). The program includes a weekend wellness retreat followed by 10 weeks of online group support. Participants will be randomly assigned to start weekly virtual sessions right away or after a 10-week delay. The study will help the investigators learn whether the program is helpful, easy to take part in, and meaningful for those who attend. The investigators believe that a culturally tailored program that focuses on healing, wellness, and community will improve emotional health, spiritual well-being, and resilience during the grief process.

Detailed Description

Rise & Renew (Remembering, Expressing, Navigating, Embracing, Witnessing) is a pilot randomized controlled trial (RCT) using a waitlist control design to evaluate the feasibility, acceptability, and preliminary outcomes of a culturally responsive hybrid grief support program for Black women aged 40 and older who have experienced the death of a spouse/significant other, parent, or child (including pregnancies).

This study addresses critical gaps in bereavement support for Black women, who often face intersecting emotional, cultural, and spiritual needs. The Rise & Renew program is rooted in wellness practices, spiritual care, and culturally grounded healing rituals.

Study Design

After completing the baseline assessment, participants will be randomly assigned (1:1) to one of two groups using a computer-generated randomization sequence:

  • Group A (Intervention Group): Will participate in an in-person weekend retreat and begin the 12-week Rise & Renew virtual support program immediately.
  • Group B (Waitlist Control Group): Will attend the same in-person retreat but will delay participation in the 12-week virtual program for 12 weeks.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Self-identifies as a Black or African American woman
  • •Aged 40 years or older at the time of enrollment
  • •Has experienced the death of a spouse, parent, or child (first-order bereavement)
  • •Resides in the U.S. South Region, including: Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, or West Virginia
  • •Has access to a reliable internet connection and a device capable of running Zoom
  • •Is able to attend a 2-day in-person retreat in the Stone Mountain, GA area
  • •Is able and willing to participate in 10 weekly virtual group sessions
  • •Provides informed consent to participate in the study
  • •Agrees to complete pre- and post-intervention surveys

Exclusion Criteria

  • •Has not experienced the death of a spouse, parent, or child
  • •Under the age of 40 at the time of enrollment
  • •Does not reside in the U.S. South Region
  • •Unable to attend the in-person retreat in Stone Mountain, GA
  • •Unwilling or unable to participate in weekly Zoom sessions
  • •Does not have access to the necessary technology for virtual sessions
  • •Does not provide informed consent
  • •Currently receiving intensive psychotherapy or psychiatric treatment that would conflict with participation
  • •Any condition or circumstance that, in the opinion of the investigators, may compromise the participant's ability to safely engage in the group setting

Arms & Interventions

Immediate Virtual Group Support

Experimental

Receives the in-person wellness retreat and begins the 10-week virtual support phase the following weekend.

Intervention: Rise & Renew Hybrid Grief Support Program (Behavioral)

Delayed Virtual Group Support

No Intervention

Attends the same in-person wellness retreat but does not begin the 10-week virtual support program until after a 10-week delay.

Outcomes

Primary Outcomes

Feasibility of Intervention Measure (FIM)

Time Frame: From baseline to the end of the 10-week support group intervention

The 4-item Feasibility of Intervention Measure was developed for evaluating the success of feasibility, demonstrating encouraging psychometric properties. The items that are scored on a scale of 0 to 4, where 0 indicates "completely disagree," and 4 indicates "completely agree". Thus, the range for each scale extends from 0 - 16, with higher scores indicating higher feasibility.

Acceptability of Intervention Measure (AIM)

Time Frame: FroFrom baseline to the end of the 10-week support group intervention

The 4-item Acceptability of Intervention Measure was developed for evaluating the success of acceptability, demonstrating encouraging psychometric properties. The items are scored on a scale of 0 to 4, where 0 indicates "completely disagree," and 4 indicates "completely agree". Thus, the range for each scale extends from 0 - 16, with higher scores indicating higher acceptability.

Intervention Appropriateness Measure (IAM)

Time Frame: From baseline to the end of the 10-week support group intervention

The 4-item Acceptability of Intervention Measure was developed for measuring the perceived fit, relevance, or compatibility of the innovation or evidence-based practice for a given practice setting, provider, or consumer, and/or perceived fit of the innovation to address a particular issue or problem. The items are scored on a scale of 0 to 4, where 0 indicates "completely disagree," and 4 indicates "completely agree". Thus, the range for each scale extends from 0 - 16, with higher scores indicating higher appropriateness.

Secondary Outcomes

  • Change from Baseline in Perceived Social Support Measured by the MSPSS at Week 10(From baseline (Week 0) to Week 10)
  • Change from Baseline in Perceived Social Support Measured by the SCSSS at Week 10(From baseline (Week 0) to Week 10)
  • Change from Baseline in Coping Strategies Measured by the Brief COPE at Week 10(From baseline (Week 0) to Week 10 (end of intervention))
  • Change from Baseline in Posttraumatic Growth Measured by the PTGI at Week 10(From baseline (Week 0) to Week 10)
  • Change from Baseline in Religious Coping Strategies Measured by the Brief RCOPE at Week 10(From baseline (Week 0) to Week 10)
  • Change from Baseline in Depression Symptoms Measured by the PHQ-8 at Week 10(From baseline (Week 0) to Week 10)

Investigators

Sponsor
Lillian Haley, PhD
Sponsor Class
Industry
Responsible Party
Sponsor Investigator
Principal Investigator

Lillian Haley, PhD

Principal Investigator

Haley Evaluation & Research Services

Study Sites (1)

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