Related Experiment Video
Updated: May 12, 2026
14:43
A Novel Method for Involving Women of Color at High Risk for Preterm Birth in Research Priority Setting
Published on: January 12, 2018
Women's experiences in a community-based participatory research randomized controlled trial
Shawn M Kneipp1, Barbara J Lutz, Catherine Levonian
1University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, USA. skneipp@email.unc.edu
Qualitative Health Research
|April 10, 2013
Summary
Community-based participatory research (CBPR) integration in studies with disadvantaged women improved experiences. Key factors included tailored questionnaires, staff interactions, and understanding randomization, leading to transformative outcomes in the randomized controlled trial (RCT).
Area of Science:
- Health Services Research
- Community-Based Participatory Research
- Clinical Trial Design
Background:
- Disadvantaged populations often benefit from community-based participatory research (CBPR) integrated into traditional study designs.
- Limited understanding exists regarding participant experiences and the processes driving positive outcomes in such integrated studies.
- Simultaneous occurrence of undesirable effects alongside positive outcomes in these studies is not well-documented.
Purpose of the Study:
- To explore the experiences of disadvantaged women participating in a CBPR-driven randomized controlled trial (RCT).
- To understand participants' interpretations of study findings and the processes influencing their experiences.
- To identify factors contributing to transformative experiences within the RCT.
Main Methods:
- Focus group interviews were conducted with 31 disadvantaged women.
- Dimensional analysis was employed to analyze qualitative data from interviews.
- Participants shared their experiences within a CBPR-driven RCT.
Main Results:
- Tailored health questionnaires significantly impacted participants' experiences.
- Interactions with study staff were a crucial element in shaping participant perceptions.
- Participants' understanding of and responses to the randomization process were key to their transformative experiences.
- CBPR and non-CBPR elements influenced both process and endpoint outcomes.
Conclusions:
- CBPR integration can lead to transformative participant experiences in RCTs with disadvantaged groups.
- Specific study design elements (questionnaires, staff interaction, randomization understanding) are critical.
- Understanding participant experiences is vital for optimizing interventions and study designs in diverse populations.
Related Concept Videos
01:13Randomized Experiments
The randomization process involves assigning study participants randomly to experimental or control groups based on their probability of being equally assigned. Randomization is meant to eliminate selection bias and balance known and unknown confounding factors so that the control group is similar to the treatment group as much as possible. A computer program and a random number generator can be used to assign participants to groups in a way that minimizes bias.
Simple randomization
Simple...
Simple randomization
Simple...
01:11Blinding
Blinding is a commonly used method of not telling participants which treatment a subject is receiving. Blinding is a critical part of a randomized control trial or RCT. It reduces the bias that affects the results. In an RCT, blinding is used in the form of a placebo. A placebo effect occurs when untreated subjects falsely believe they have received the treatment and report improved symptoms. A placebo or a dummy treatment is administered to subjects to negate the bias caused by such an effect.
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:16Clinical Trials
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
01:20Study Designs in Epidemiology
Epidemiological study designs are fundamental tools for investigating the distribution, determinants, and control of health conditions in populations. They help researchers understand the relationships between exposures and outcomes, and they broadly fall into two categories: "observational" and "experimental" studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.
Observational studies are those where the researcher does not intervene but rather observes natural variations. They include cross-sectional, cohort, and case-control studies.
01:30Community Based Intervention
Community-based interventions in mental health represent a paradigm shift from institution-centered care to treatments embedded within the fabric of local communities. By prioritizing inclusion and leveraging existing societal structures, this approach fosters a supportive environment conducive to addressing mental health challenges while promoting individual dignity and agency.
Foundations of Community Mental Health Programs
Central to the success of community-based interventions is the...
Foundations of Community Mental Health Programs
Central to the success of community-based interventions is the...