607 Clinical Trials for Various Conditions
These are the exploratory aims of the original trial cohort study "Old School Hip Hop RCT (AAAR5473)," which recruited 783 parents. 1. Continued follow-up of these families to learn more about the durability of the program through similar assessments to those used during the pre-specified 3-month initial study timeframe - aiming to understand participant knowledge and personal experiences with family members or friends affected by Alzheimer's Disease (AD). 2. Further examining the degree of comfort with dementia, as measured by a simplified version of the Dementia Attitudes Scale (DAS) focused on observable behaviors in children by their parents - aiming to understand the extent of stigmatization of dementia in communities served by this program, and if the trial impacted evidence of stigma. 3. Enrolling up to 75 parents who primarily spoke Spanish who were originally contacted in the RCT but were not eligible for completion of the original round of surveys given that all study materials were in English. This approach aims to better understand the impact of the program and Alzheimer disease on these families. Hypothesis 1: For the delayed follow-up with parents, the investigator anticipates that those with high dementia literacy or the largest dementia literacy improvement would sustain knowledge over 15-month period. Hypothesis 2: Children who received the intervention arm of the trial, who also have regular contact with a close friend or family member with dementia, will demonstrate positive dementia attitudes relative to students in the control arm. Hypothesis 3: Semi-structured interviews with Spanish speaking families will help program capacity to better serve the population and improve involvement in AD care and research.
This is a pilot trial of a school-partnered collaborative care (SPACE) model for pediatric type 1 diabetes. The trial will investigate the feasibility and acceptability of SPACE for children with type 1 diabetes in the school setting. SPACE is adapted from a collaborative care model used to treat depression and other mental health care conditions in adolescents and adults.
The primary goal of this study is to test the effectiveness of the iDECIDE (Drug Education Curriculum: Intervention, Diversion, and Empowerment) curriculum, a novel drug education and diversion program, in approximately 300 middle and high school students, who have violated their school substance use policies in the past month, as an alternative to punitive school responses for school-based substance use infractions. This randomized controlled trial will test the hypothesis that adolescents randomized to the iDECIDE curriculum will have improved substance use outcomes (i.e., knowledge, attitudes, and behavior) compared to adolescents in a waitlist control group. The outcomes of this study will measure knowledge of drug effects and brain development, perceptions of harm from substance use, willingness to quit or reduce use, and substance use behavior.
This study will assess how different types of training and support influence the way that school staff understand, and respond to, the mental and behavioral health needs of middle school students. Researchers will work with middle schools using a developed screening system (called the Early Identification System; EIS) and compare how staff and student outcomes change when schools receive two different types of training and support: 1) standard onboarding/training versus 2) participating in professional learning communities and coaching.
The goal of this clinical trial is to compare two school based interventions to manage anxiety in autistic students. The main question\[s\] it aims to answer are: 1) Compare the effectiveness of Facing Your Fears-School Based Program (FYF-SB) with Zones of Regulation (ZOR) on anxiety reduction and emotion regulation; and 2) examine the feasibility and satisfaction of FYF-SB and ZOR, according to students, caregivers and school providers. Autistic students with anxiety between 8-14 years will be randomized to either FYF-SB and ZOR. They will participate in one of the programs for 12 weeks and pre, post and follow-up measures will occur.
The prevalence of childhood hearing loss in rural Alaska is disproportionately high and predominately infection-related. With preventive screenings and access to health care, much of childhood hearing loss is preventable. Although state-mandated school screening helps identify children with hearing loss, loss to follow-up is pervasive and exacerbated by a scarcity of specialists in rural regions. A mixed methods cluster randomized trial conducted in northwest Alaska demonstrated that telemedicine can significantly reduce loss to follow-up. This stepped wedge trial, in partnership with Southcentral Foundation, will build on this existing work to develop a model that can be scaled in diverse environments. We will adapt and implement a new telemedicine intervention called Specialty Telemedicine Access for Referrals (STAR). This trial will be conducted in 3 regions in rural Alaska that represent multiple healthcare systems. Based on stakeholder feedback and evidence generated from the previous trial, an enhanced mobile health (mHealth) hearing screening will be implemented in all participating schools prior to the STAR intervention, and the telemedicine referral to specialty care (STAR intervention) will be moved from the clinic directly into the school. This stepped-wedge cluster randomized trial is part of a larger hybrid type 1 effectiveness-implementation trial. The stepped wedge trial will evaluate the effectiveness of the STAR intervention in reducing loss to follow-up from referred school hearing screening in 3 regions of Alaska: Kodiak, Petersburg and Lower Yukon (n=23 schools, \~2,015 K-12 students/year). The STAR Intervention will be compared to the standard referral of a letter home to families. Cluster randomization at the level of school will be performed, with schools (clusters) randomized to one of two sequences. The effectiveness outcome (i.e., proportion of children who receive follow-up) will be evaluated over three academic years (2023-2026), with STAR rolled out in a stepwise manner for each of the two sequences (academic year 2024-2025 for sequence 1 and academic year 2025-2026 for sequence 2). The control periods for each sequence will be academic year 2023-2024 for sequence 1 and academic years 2023-2024 and 2024-2025 for sequence 2. Enhanced screening will be rolled out to both sequences at the same time (i.e., non-randomized) beginning academic year 2023-2024. An implementation evaluation will be conducted to refine and adapt the enhanced hearing screening and STAR intervention throughout the trial. Implementation data will be collected starting academic year 2022-2023 and then annually for each of the subsequent years.
This trial will evaluate a multilevel intervention (STAR model) that combines mobile health (mHealth) hearing screening tools with telemedicine technology for specialty care access in rural Kentucky schools. An initial version of the model was used in rural Alaska where telemedicine-based specialty referral improved both proportion of children receiving follow-up and time to follow-up. The refined STAR model will utilize an enhanced mHealth screening protocol that includes tympanometry for the detection of middle ear disease. The STAR model will also include a specialty telemedicine referral process in schools for children who refer school screening.
Schools are critical settings to foster children's health. The purpose of this two-year cluster-randomized trial is to enhance both the after-school and recess settings to provide children with knowledge and skills to facilitate active and inclusive play. The primary aim of the project is to assess the impact of a playground curriculum intervention on children's physical, social, emotional, and behavioral health. The secondary aim of the project to understand the appropriateness, feasibility, fidelity, and sustainability of implementing a playground curriculum in after-school and recess settings.
Currently, millions of children in preschools, schools, and in afterschool continue to receive breakfast, lunch, snacks and supper through these programs. Thanks to federal nutrition standards and reimbursements, school meals are generally healthier than meals from home, particularly for students from low-income households. Participation in these programs, beginning in the earliest years, reduces food insecurity and improves child health and academic performance. Despite USDA administrative flexibilities issued during the COVID-19 pandemic, participation in school nutrition programs has decreased. This trial will examine whether an intervention that focuses on communicating the benefits of child nutrition programs and establishes a feasible and sustainable strategy for parents to provide ongoing feedback to improve the appeal, cultural relevance, and quality of school meals will increase school meal participation to reduce food insecurity and promote child health.
This study will target Madison Metropolitan School District (MMSD) school children ages 4-19 and staff who have not had a previous positive COVID-19 test within the past 3 months. It will enroll children and adults for 1-3 days to explore whether serial "at-home" BinaxNOW testing is feasible and non-inferior to "at school" single PCR testing for the evaluation of symptomatic individuals with a negative initial BinaxNOW. It will also explore whether lollipop swabs are more acceptable and perform as well as nasal swabs with polymerase chain reaction (PCR) testing.
This study aims to disseminate Hip Hop Stroke 2.0 (HHS2.0) to a more heterogeneous (urban, suburban, and rural population) via NYS Stroke Centers through a partnership with the New York State Department of Health (NYSDOH) Stroke Designation Program. This digital program is a second part to an original Hip Hop Stroke program where study showed effectiveness at communicating stroke awareness. In this study, the investigator proposes to intervene in school classrooms with the Hip Hop Stroke 2.0 (HHS2.0) digital program, geared towards children aged 9 to 11 years. Primary Aims: Aim 1: To identify contextual factors, such as barriers and facilitators, that influence uptake of the HHS program in a new, heterogeneous sample at the Stroke Center and local school levels. Hypothesis 1: Contextual factors at the Stroke Center and local school levels will lead to differential uptake of HHS. Aim 2: To determine whether Stroke Center implementation of the HHS program leads to increased stroke literacy of local students by cross-validating outcomes with the results of our Randomized Clinical Trial. Hypothesis 2: Stroke Center implementation will lead to increased stroke literacy of local students. Secondary Aims: Aim 3: To assess the determinants of high performance implementation and effectiveness under real world practice conditions. Aim 4: To evaluate the costs associated with HHS program implementation.
This project will examine the scale-up of Schoolwide Positive Behavior Intervention Supports (SWPBIS), specifically focusing on rural schools in Idaho. The Idaho Rural Implementation Model (I-RIM) is an approach designed to improve SWPBIS implementation in rural schools, via strategies such as capacity-building, regional coordination, online learning modules, and technical assistance. The study uses a cluster randomized design to allocate 40 schools to one of two conditions: control and intervention. Schools in the control condition will receive basic SWPBIS training. Schools in the intervention condition will receive the basic SWPBIS training plus additional I-RIM supports. To assess SWPBIS implementation and outcomes, process and outcome measures will be collected. Outcomes will include school implementation observations, and teacher and staff implementation measures. Student-level outcomes will include behavior, perceived climate, and academic achievement as measured by the standardized state test. Student-level data include those that are part of standard data collection by schools (such as academic outcomes) and will be de-identified by school officials before sending to the researchers for analysis.
The investigators propose an efficacy study (i.e., do salad bars work under controlled conditions in naturalistic settings) to test whether introducing salad bars in elementary, middle, and high schools that have never had salad bars affects students' FV consumption and waste during lunch. A cluster randomized controlled trial will test new salad bars against controls for 6 wks, with/without an additional 4-wk marketing phase .
BOKS, Build Our Kids' Success, is a before-school physical activity program that has been implemented in over 2,000 elementary and middle schools. Students participate in the program for 12 weeks, two or three mornings per week for about 1 hour per session. This study if a non-randomized control trial seeking to 1) examine the extent to which participation in the before-school BOKS program improves, health, well-being, and performance, and 2) compare the results of a two-day-per-week versus a three-day-per-week program.
It is widely argued that the promotion of water consumption, as an alternative to sugar-sweetened beverages, can assist in childhood obesity prevention efforts. Yet no studies have tested this argument in real world schools where flavored milk or juices are available. This trial will fill gaps by examining how promoting fresh water intake-both in schools that do and do not provide access to caloric beverages -impacts children's consumption of food and beverages both during and outside of school, and obesity.
The purpose of this study is to determine whether school gardens influence children's dietary intake, nutritional knowledge, and other outcomes.
Attention-Deficit/Hyperactivity Disorder (ADHD) is one of the most commonly diagnosed childhood disorders, with prevalence rates estimated at 8%. Several of the primary symptoms of ADHD relate to problems with temporal and materials organization (i.e. has difficulty organizing tasks and activities, loses things, is forgetful, and fails to finish school-work). In the school setting, problems with organization manifest as forgetting to complete or losing homework assignments, difficulties planning for the completion of long-term projects and studying for tests, and problems keeping class materials organized. These organizational difficulties become particularly problematic in middle school and are associated with low school grades and high parent and teacher ratings of academic impairment. In fact, organization of homework materials is one of the strongest predictors of academic performance in students with ADHD, above and beyond the impact of intelligence, school services, and ADHD medication use, and mediates the relationship between symptoms of ADHD and school grades. Given the relationship between temporal and materials organization and poor school performance, it is clear there is a need for interventions to address these difficulties. The PI sought to address this need by completing an IES Goal 2 study to develop a school-based intervention targeting organizational skills that was feasible for school mental health (SMH) providers to implement. The Homework, Organization and Planning Skills (HOPS) intervention was developed and refined based upon input from 20 school mental health (SMH) providers, students with ADHD and their families. SMH providers implemented the HOPS intervention, rated the intervention as highly user-friendly and feasible to implement, and demonstrated excellent fidelity to intervention procedures. Students who received the HOPS intervention made significant improvements in homework problems and organizational skills compared to a waitlist control. The feasibility and fidelity data demonstrate that the intervention has potential for widespread dissemination. Preliminary outcome data suggest that the intervention may significantly improve the academic performance of students with ADHD. However, the small sample size (N=23 HOPS \& N=24 control) precludes firm conclusions about efficacy and moderators and mediators of intervention response. Accordingly, the primary goal of this Goal 3 study is to evaluate the efficacy of the HOPS intervention, which focuses teaching students' organization and time-management skills, as compared to an intervention targeting on-task behaviors during homework completion and efficiency of work completion, the Homework Support Intervention (HSI), and to assess moderators and mediators of intervention response. Middle school students with ADHD (N=260) will be randomly assigned to receive the HOPS intervention or the HSI intervention. Students in both groups will receive the same amount of intervention in terms of duration and frequency of intervention sessions. Six cohorts of students will be recruited for the project. Each cohort will consist of 22 students at each of two schools (44 per cohort) who will be randomly assigned to each of the two conditions. Objective measures of skills implementation, parent and teacher ratings of organization, homework problems, and academic impairment, and school grades will be examined pre and post intervention as well as at 8-week and 6-month follow-ups. Treatment fidelity and integrity will be closely monitored. Moderator and mediator analyses will be used to answer important questions about the types of students most likely to benefit from organizational skills intervention and the key mechanisms of change that lead to improved academic performance. This study has significant potential to improve the academic performance of students with ADHD because the intervention was designed with SMH provider input and has clear potential for widespread dissemination upon proof of efficacy.
The purpose of this study is to determine whether school gardens affect children's physical activity.
The primary goal of the proposed research is to assess the effectiveness of the Adolescent Depression Awareness Program (ADAP), a school-based depression education program, in increasing depression literacy and treatment seeking in high school students. The ADAP intervention will be carried out in approximately 60 schools with over 15,000 students. The following are ADAP Implementation Sites: Baltimore Archdiocese High Schools; New Castle County, Delaware; Washtenaw County, Michigan; and York County, Pennsylvania.
Yoga is becoming a part of therapies for children with emotional behavioral disorders. The goal is to examine the feasibility and efficacy of yoga sessions for children with emotional behavioral disorders at an urban elementary school.
Walking to school is one of the objectives for children and adolescents in Healthy People 2010 and in previous studies was associated with higher levels of overall physical activity, which has been shown to decrease obesity. Therefore, more children walking to school should result in increased physical activity and presumably reduce obesity. However, increasing child pedestrian activity could increase the risk of child pedestrian injuries. Walking with an adult who provides instruction in pedestrian skills and monitors the child's actual behavior may be the most important component of a successful intervention. Walking with an adult reduced child pedestrian injury risk by almost 70%. A walking school bus (WSB) addresses safety concerns by providing a period of physical activity supervised by several responsible adults and teaching opportunities around pedestrian safety skills on the way to and from school. Children may join the WSB at various points along the set route. Despite the growing popularity of WSB programs in the United States, randomized, controlled-studies are lacking that examine the impact on children's safety, physical activity, and health. We seek to help fill this gap in the literature by piloting a WSB program in elementary schools in the Houston Independent School District to test feasibility. We hypothesize that a WSB program will: (1) increase the number of students walking to school and decrease the number of students driven to school by car, (2) increase students' pedestrian safety behaviors (3) increase students' physical activity, and (4) decrease students' excess weight gain.
This study will determine the effectiveness of a school-based cognitive behavior therapy in urban, predominantly low-income, African-American children diagnosed with an anxiety disorder.
The purpose of this study is to determine whether a walking school bus program can increase the number of children walking to school and decrease the number of children driven by car to school.
This study will develop a program to help school children deal with violence-related trauma.
The purpose of this study is to develop and evaluate the effectiveness of a parent-based intervention that can be implemented in conjunction with existing school-based programs designed to prevent or reduce sexual risk behavior or to prevent or reduce tobacco use in young adolescents. The parent programs are expected to have effects on adolescent behavior over and above the effects of the school-based programs.
As many as 78% of children with autism spectrum disorder (ASD) have significant sleep disturbance compared to 20% of children without ASD. In children with ASD, shorter sleep duration and lower sleep efficiency, are associated with disruptive behavior, anxiety, and increased parental stress. Therefore, multiple sleep dimensions (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration) are appropriate therapeutic targets to improve daytime behavioral functioning and other psychosocial outcomes. The primary objective is to evaluate the implementation of a modification of a behavioral sleep and circadian intervention to improve multiple sleep dimension in school-age children with ASD. To accomplish this objective, a 12-week, randomized pilot study will be conducted to assess the feasibility, acceptability, and preliminary efficacy of a modified behavioral sleep and circadian intervention with up to 50 school-age children with ASD, to determine whether the intervention improves multiple dimensions of sleep (B-SATED: behaviors, satisfaction, alertness, timing, efficiency, duration), daytime behavior, quality of life, parental stress, and parental self-efficacy. This modified intervention is guided by the Pediatric Sleep Health Framework that encourages improvement in six pediatric sleep dimensions (B-SATED): sleep behaviors; parents' satisfaction with child sleep; daytime alertness/sleepiness; appropriate timing of sleep within the 24-hour day; sleep efficiency, i.e., ease of falling and staying asleep; and sleep duration. The Sadeh and Anders Sleep-Wake Regulation Model was used to propose linkages between outcomes. The investigators hypothesize that parents implementing the modified intervention will improve the primary outcome (clinician- and parent-ratings of child sleep) and secondary child (sleep dimensions, daytime behavior, quality of life) and parent outcomes (stress and self-efficacy).
The purpose of this study is to identify community-level barriers and facilitators for active transport and leisure physical activity and to co-create and test the effectiveness and longer-term sustainability of community-based physical activity intervention strategies in middle schools. Participation in this study may help the investigators and scientific community better understand and address child physical activity and health. This study will collect information about middle school children's physical activity behaviors, habits, knowledge, and activity. The UTHealth School of Public Health is leading the study together with the University of Texas at Austin.
This proposal will implement and test feasibility and efficacy of school-based art therapy and yoga/mindfulness programming to reduce mental health disparities and foster resilience in youth. We will conduct a cross-over randomized trial with n=250 youth (any race/ethnicity or gender, ages 11-14) from two schools: one serving majority Black/African American students and one serving a population-representative ethnoracial demographic with 50% economically disadvantaged students. Baseline data collection will assess experiences of discrimination, negative experiences, positive experiences, and severity of posttraumatic stress, anxiety, depression, somatic symptoms, and resilience. Youth will be randomly assigned to art therapy or yoga/mindfulness for a quarter. Hour-long weekly sessions will occur during elective course times within school to bolster accessibility and generate data to inform future school-based care models for sustainability. Target schools co-developed this design with the research team. At the end of the quarter, participants will engage in post-intervention data collection, including qualitative interviews regarding their experience with the school-based programming. Participants will then cross over to the yoga/mindfulness or art therapy for the subsequent quarter, such that all participants receive both modalities. The methods described above will be repeated, including the assessments. Academic performance will be assessed throughout. We hypothesize that both modalities will be effective in reducing stress, anxiety, and depression related to discrimination, adversity, and trauma that disproportionately impacts racially and ethnically minoritized youth. We anticipate that qualitative feedback will identify points of optimization for programming and inform which students may be most responsive to what intervention(s).
The main goal of this study is to evaluate the "SIESTA" intervention, a culturally and contextually tailored sleep hygiene intervention that has the potential to exert greater improvements in sleep hygiene and sleep outcomes for group that may be more vulnerable to poor sleep health. The main question is: do SIESTA participants have improved sleep outcomes, sleep hygiene behaviors and less sleep-related impairment compared to Control Group participants? Participants randomized to the SIESTA intervention will: 1. Attend 4 remotely administered group sleep hygiene education sessions 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. Participants randomized to the Child Health Control condition will: 1. Attend 4 remotely administered group sessions covering general health topics 2. Complete along with a parent/guardian, two individualized sessions administered by a SIESTA intervention facilitator 3. Complete study survey at baseline, end of treatment, and at 4, 8 and 12 months post-intervention. 4. Wear electronic sleep watches (actigraphy) throughout the protocol to objectively measure sleep duration and quality. A secondary goal of the study is to conduct a process evaluation to prepare for future larger scale use of the intervention in other urban school settings. This will entail assessing Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) of the program through several methods, such as by conducting in-depth interviews with research participants and their parents/guardians, as well as school staff and by looking at rates of participation in the program.
The purpose of this study is to compare COVID-19 knowledge, experiences, and health behaviors between participants who received the health initiative and those who did not.