Due to underrepresentation of racial/ethnic minority and low-income groups in clinical studies, there is a call to improve the recruitment and retention of these populations in research. Pilot studies can test recruitment and retention practices for better inclusion of medically underserved children and families in subsequent clinical trials. We examined this using a school-based asthma intervention, in preparation for a larger clinical trial in which our goal is to include an underserved study population.
We recruited children with poorly controlled asthma in a two-site pilot cluster randomized controlled trial of school-supervised asthma therapy versus enhanced usual care (receipt of an educational asthma workbook). We sought a study population with a high percentage of children and families from racial/ethnic minority and low-income groups. The primary outcome of the pilot trial was recruitment/retention over 12 months. Strategies used to facilitate recruitment/retention of this study population included engaging pre-trial multi-level stakeholders, selecting trial sites with high percentages of underserved children and families, training diverse medical providers to recruit participants, conducting remote trial assessments, and providing multi-lingual study materials.
Twenty-six children [42.3% female, 11.5% Black, 30.8% Multiracial (Black & other), 76.9% Hispanic, and 92.3% with family income below $40,000] and their caregivers were enrolled in the study, which represents 55.3% of those initially referred by their provider, with 96.2%, 92.3%, and 96.2% retention at 3-, 6-, and 12-month follow-up, respectively.
Targeted strategies facilitated the inclusion of a medically underserved population of children and families in our pilot study, prior to expanding to a larger trial.

Aggression tends to decrease as a child matures and develops conflict resolution skills. However, aggression can persist if children are exposed to consistent negative stimuli, such as poor parenting and adverse childhood experiences (ACEs). Furthermore, aggression is commonplace in numerous psychiatric disorders, such as attention deficit hyperactivity disorder (ADHD) and oppositional defiant disorder. These negative stimuli and comorbid conditions could ultimately stunt a child\'s development during pivotal moments, leading to worsening aggressive behaviors, such as criminal activity. Behavioral interventions are imperative for individuals with these comorbid conditions and experiences. Our patient is an 11-year-old male with a pertinent past medical history of ADHD and disruptive mood dysregulation disorder (DMDD) on multiple psychotropic medications, who presented to the emergency department for the evaluation of homicidal ideation and suicidality. This also occurred with worsening aggressive behavior, demonstrated by his killing of family pets and subsequent threats to kill his family. The patient has had multiple emergency department visits for similar threats and has been admitted to numerous inpatient psychiatric facilities. Currently, the patient is being treated at an out-of-state inpatient psychiatric facility. Our patient\'s aggression most likely stems from his comorbid ADHD and DMDD, complicated by other factors, such as low socioeconomic status, limited access to mental health services, and living in a medically underserved community. Factors such as increasing primary care provider comfort in managing these conditions, especially in underserved communities where there are already shortages of mental health providers, could help address this issue. Furthermore, it is imperative to screen for other contributing factors, such as ACEs. This case also highlights the need for genetic testing as a part of the medical workup in psychiatric cases that display psychotropic medication resistance. However, genetic testing is something that is not readily available in our state and is not covered by Medicaid. Early treatment of mental health conditions can prevent social difficulties later in life. With aggression, providing appropriate interventions is key to preventing an individual from engaging in harmful activities. It is important to screen for ACEs in order to address well-known aggravating factors. Underserved populations also face a myriad of challenges that prevent them from accessing healthcare services. There are numerous problems contributing to this disparity, ranging from lack of adequate mental health services to lack of access. Accordingly, it is imperative that primary care physicians and providers practicing in underserved areas receive the training necessary to recognize and treat mental health conditions. Furthermore, physicians should be able to focus on psychosocial stressors that contribute to these mental health conditions and provide the resources necessary to address these factors.