684 Clinical Trials for Various Conditions
The purpose of this study is to evaluate the efficacy of Latino parent-focused education that combines enhancing parent engagement, building quality parent-child relationships, promoting healthy eating and physical activity, and engaging families with community resources for healthy foods on youth energy balance related behaviors and weight status.
The purpose of this project is to pilot test an electronically delivered symptom assessment tool Pediatric Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (Ped-PRO-CTCAE), completed by children/adolescents and young adults (AYAs) and caregivers and shared with their clinicians during an outpatient clinic visit, in preparation for a future test of intervention efficacy.
The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities and to address barriers to equity, through the acquisition of civic leadership and development skills as well as mindfulness practice, LEAP: Leadership, Engagement, and youth Activism Program with Mindfulness. The goal of our proposal is to determine whether the Leadership, Engagement, and youth Activism Program with Mindfulness (LEAP) curriculum, which was developed with youth of color, is a feasible and effective intervention for fostering civic leadership, civic development, and wellbeing. We seek to understand whether LEAP can support wellbeing for youth of color as a strategy to increase youth mental, emotional, and behavioral (MEB) health and decrease health disparities in youth of color.
The aim of this study is to assess the impact of an in-person multi-component Advanced Cooking Education (ACE) 4-H after school program. The ACE Program consists of mindfulness, nutrition education, cooking labs, and professional development activities.
The goal of this randomized controlled trial is to evaluate "Step Up for STEM and Health Careers". The "Step Up for STEM and Health Careers" ("Step Up") game is an interactive, digital resource that includes the key elements of a bystander intervention for high school students to understand the importance of diversity in STEM; it also addresses skills, attitudes, and awareness to attain positive STEM identities and mitigate bias and harassment in STEM and health learning environments. Participants in the intervention arm will be asked to complete the Step Up interactive game; participants in the comparison group will be asked to view a PowerPoint presentation on bias and harassment in STEM/health fields as the control experience. The Step Up game intervention and study outcomes are theory-based (Theory of Planned Behavior, Social Cognitive Career Theory (SCCT)): we will assess the impact of Step Up on attitudes about STEM/health careers, STEM/health career self-efficacy, and bystander behavior.
The current study tests the feasibility and effectiveness of a youth intervention designed to provide meaningful leadership opportunities and to address barriers to equity, through the acquisition of civic leadership and development skills as well as mindfulness practice, LEAP-M: Leadership, Engagement, and youth Activism Program with Mindfulness. The goal of our proposal is to determine whether the Leadership, Engagement, and youth Activism Program with Mindfulness.(LEAP-M) curriculum, which was developed with youth of color, is a feasible and effective intervention for fostering civic leadership, civic development, and wellbeing. We seek to understand whether LEAP-M can support wellbeing for youth of color as a strategy to combat structural racism at the school- and neighborhood-levels, increase youth mental, emotional, and behavioral (MEB) health and decrease health disparities in youth of color.
This study will deploy a scalable secondary prevention program that leverages existing foster youth transition services to improve mental health functioning and service use before and after exiting foster care. Our short-term objective is to remotely test a group intervention called Stronger Youth Networks and Coping (SYNC) that targets cognitive schemas influencing stress responses, including mental health help-seeking and service engagement, among foster youth with behavioral health risk. SYNC aims to increase youth capacity to appraise stress and regulate emotional responses, to flexibly select adaptive coping strategies, and to promote informal and formal help-seeking as an effective coping strategy. The proposed aims will establish whether the 10-module program engages the targeted proximal mechanisms with a signal of efficacy on clinically-relevant outcomes, and whether a fully-powered randomized control trial (RCT) of SYNC is feasible in the intended service context. Our first aim is to refine our SYNC curriculum and training materials, prior to testing SYNC in a remote single-arm trial with two cohorts of 8-10 Oregon foster youth aged 16-20 (N=26). Our second aim is to conduct a remote two-arm individually-randomized group treatment trial with Oregon foster youth aged 16-20 with indicated behavioral health risk (N=80) to examine: (a) intervention group change on proximal mechanisms of coping self-efficacy and help-seeking attitudes, compared to services-as-usual at post-intervention and 6-month follow-up: and (b) association between the mechanisms and targeted outcomes, including emotional regulation, coping behaviors, mental health service use, and symptoms of depression, anxiety, and PTSD. Our third aim is to refine and standardize the intervention and research protocol for an effectiveness trial, including confirming transferability with national stakeholders.
The principal objective of Tennessee Youth Prepared for Success is to pilot, implement, and test innovative adolescent pregnancy prevention strategies using a randomized controlled trial (RCT) to effectively educate youth on both abstinence and contraception with the goal of reducing youth pregnancies, births, and STIs. Tennessee Youth Prepared for Success will address Adulthood Preparation Subjects (APS) to promote youths' successful and healthy transition to adulthood; include a Positive Youth Development (PYD) approach to engage youth and provide positive influences and skill building opportunities; and implement activities/interventions within a trauma-informed approach to account for the mental health needs of those who have experienced maltreatment, abuse, or violence. The project's goals and principal and subordinate objectives align with the PREIS program's goals/objectives and purpose, including (1) targeting high-risk youth to prevent pregnancy and STIs, including HIV/AIDS; (2) rigorously evaluating interventions using an RCT; (3) manualizing/packaging curriculum; and (4) disseminating lessons learned, best practices, and relevant findings. Tennessee Youth Prepared for Success will serve 1,200 youth ages 14-19 in 9 primarily rural counties in East/Middle/West Tennessee, targeting high-risk/vulnerable youth, including rural youth, those residing in counties with high teen birth rates, and/or hard-to-reach youth (e.g., systems-involved).
The study aims to implement Using the Connect (UTC), an innovative, game-based intervention designed to increase protective factors and decrease adolescent pregnancies. This intervention will be implemented in Texas middle schools and community-based organizations. The long-term goal is to promote optimal health in youth and prevent adolescent pregnancy in populations disproportionately impacted by adolescent pregnancy and sexually transmitted infection (STI) rates. The short-term objective is to conduct a robust, multi-site clustered randomized controlled trial to evaluate implementation outcomes and the impact of UTC, a novel theory-based game developed using powerful and effective human-centered design (HCD) strategies, on intention to delay sexual activity.
The aim of this study is to assess the impact of an in-person multi-component Advanced Cooking Education (ACE) 4-H after school program. The ACE Program consists of mindfulness, nutrition education, cooking labs, and professional development activities.
The aim of this study is to look at outcomes related to diet and nutrition, mindfulness, and cooking skills amongst middle school students who participated in a 12-week 4-H after school program called the Advanced Cooking Education Program.
This is a Phase III, randomized, one-center, three arm parallel group, open label and single blind clinical study to evaluate the effectiveness of a cognitive behavioral intervention (CBI) adjunctive to a smart powered toothbrush on the oral health of adolescents.
Investigators will conduct a pilot randomized controlled trial assessing the efficacy and feasibility of the newly developed Family Media Check-In (FMC).
This study looks to conduct a systematic adaptation of Suicidal Teens Accessing Treatment (STAT-ED) for Black youth presenting in the emergency department who have suicide risk. A randomized controlled trial of STAT-ED adapted for Black youth and their caregivers will examine whether patient navigation intervention can increase mental health treatment initiation and number of visits.
The primary goal of this study is to evaluate the effectiveness of the iDECIDE curriculum as an alternative to punitive responses for school-based substance use infractions.
The current investigation consists of the implementation and modest refinements of a culturally adapted version of the evidence-based PT intervention known as GenerationPMTO.© The adapted intervention, CAPAS-Youth, is primarily delivered to parents. The primary research objectives are twofold: a) to conduct refinements of the CAPAS-Youth intervention for Hispanic immigrants in mid-Texas, and b) to measure implementation barriers and precursors, as well as implementation outcomes, in an effort to inform a future study focused on scaling the intervention. A special focus on faith-based organization informs the intervention, as a way of increasing reach with underserved Hispanic immigrant communities.
The purpose of this study is to develop and evaluate a multi-level (youth, parent, school) Internet-based dating violence prevention program, 'Me \& You-Tech' (MYT) for 6th-grade middle school students.
This is a single-site, randomized, controlled trial. Investigators will evaluate feasibility of the Emergency Department Healthcare Education Assessment and Response for Teen Relationships (ED-HEART) intervention among adolescents age 14-19 years receiving care in the Children's Mercy emergency department.
This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th or 10th graders in two high schools in Pittsburgh, Pennsylvania.
This research project will explore the feasibility and acceptability of a web-based media literacy tobacco prevention program. The project will be conducted with 9th graders in two schools in the Pittsburgh area.
The randomized, two-arm pragmatic trial will test the effectiveness of offering 6-months of telephonic support from a mental health (MH) navigator to promote early access, engagement, coordination, and personalization of mental health treatment and services for children naïve to such treatments and services, and who are identified as being at risk for behavioral health concerns. The model includes: (a) automated identification of early symptoms for children meeting criteria for behavioral health problems using a previously developed Natural Language Processing (NLP) program and predictive algorithm; (b) standardized instruments for assessment and diagnosis of mental health disorders (c) 30 minute assessment appointments with a study psychologist (d) creation of an Epic "reporting workbench" and Epic "smart form" to facilitate the outreach, monitoring and follow-up of families/children by the MH navigator; (e) use of MH Navigators (e.g., clinical social workers) to conduct family outreach, and coordination with and between clinicians; and (f) the offer of one to four clinic-to-home videoconferencing brief therapy sessions to bridge families/children unwilling or unable to access in-person MH services.
Using an adapted stress-reduction intervention called the CEDARS, the investigators will pilot the intervention in adolescents (N=40) to determine the feasibility and acceptability of CEDARS implementation and to investigate adolescent stress reduction. As an exploratory aim, the investigators will explore the influence of the CEDARS on CMH-related behaviors and CMH. The investigators expect that those adolescents who undergo the intervention will have the greatest improvement in mental health symptoms than their waitlisted counterparts. Our secondary hypothesis is that those who report more adversity will also report greater improvement in mental health symptoms than their peers.
The purpose of this study is to test the impact of a 6-week theatre intervention rooted in African culture (Sankofa) on the wellness of girls (predominately African American) ages 8-18 receiving services at five Boys \& Girls Club Indianapolis sites. Theatre interventions are led by Asante theatre personnel and evaluated by the PI and occupational therapy graduate students. The theatre intervention being evaluated has been conducted for decades by an established theatre company with widespread community participation and anecdotal positive responses, but has not been scientifically evaluated to understand how it impacts wellbeing. This will be the first large-scale study of the mechanisms of change and of the impact of the theatre intervention in the community and will help to guide future therapeutic interventions using theatre with underserved populations. Research questions include: Is Sankofa a feasible and acceptable intervention for the target population? Does participation in Sankofa result in improved scores on wellness outcome measures, including the National Youth Outcomes Initiative (NYOI) survey? The study is funded by Asante Children's Theatre via the Central Indiana Community Foundation Women's Fund.
This cluster-randomized community-partnered study will examine the effectiveness of a trauma-sensitive, gender transformative youth violence prevention program called Creating Peace that integrates racism and discrimination prevention with youth ages 14-19.
This pilot quasi-experimental community based trial examines the feasibility of a sexual violence and adolescent relationship abuse prevention program for girls aged 14-19. Feasibility is assessed through participant attendance, retention and program satisfaction measures and interviews are conducted at baseline, end of program and 3 month follow up (endline) about participant experiences.
The purpose of this experiment is to determine whether social buffering by friends of stress physiology remains effective later in puberty when friends share the load versus when they provide support but are not undergoing the stressor with the target child. There are four conditions: (1) Friend and Target both undergo the stressor, (2) Friend provides support but does not undergo the stressor, (3) Unfamiliar Peer and Target undergo the stressor, and (4) Alone (no partner).
This cluster-randomized school-based study will examine the effectiveness of a teen dating violence (TDV) and sexual violence (SV) prevention program called Expect Respect for preventing serious violence perpetration among middle school students.
This project is designed to 1) develop a PrEP implementation plan for a general adolescent clinic. Investigators will develop a replicable implementation plan for providing PrEP to adolescents in a primary care setting; and 2) Determine the acceptability and preliminary effectiveness of a telehealth intervention to promote adherence in adolescents.
The overall goal of this study is to investigate associations between sleep/circadian disturbances and psychiatric health among adolescents recruited from primary and specialty health clinics.
This study aims to advance the science of mental health services for adolescent externalizing problems (AEPs) by developing therapist training procedures to increase fidelity to evidence-based interventions (EBIs) in usual care. Two widely endorsed approaches are consistently effective for treating AEPs: family therapy and CBT. Importantly, stronger fidelity to core EBIs of these approaches predicts better outcomes in research and community settings. Yet these EBIs are not widely implemented with fidelity. To help close this quality gap in adolescent services, investigators will develop an online intervention to strengthen fidelity to these EBIs in routine care: Measurement Training and Feedback System for implementation (MTFS-I). MTFS-I will target two essential aspects of EBI fidelity: Training components will seek to improve EBI self-monitoring, and a Feedback component will seek to increase EBI utilization. In keeping with NIMH's Experimental Therapeutics paradigm, this study will examine whether an Intervention (MTFS-I) has direct impact on immediate Targets (EBI self-monitoring and utilization). If promising, future R01 studies will examine links among intervention, targets, and ultimate outcomes (AEPs). The MTFS-I package will be an online quality assurance system completed by therapists and supervisors that can be readily sustained in usual care. Two weekly Training components will adapt gold-standard observational fidelity coding procedures to promote improved self-monitoring of the targeted EBIs, and a monthly Feedback component will adapt a measurement feedback system to promote increased utilization of these EBIs in everyday practice. To maximize provider investment, sites will delineate their own fidelity standards for family therapy and CBT and help design feedback report templates. The proposed study will be among the first to (1) test whether training therapists in observational assessment of EBI fidelity increases the accuracy with which they self-monitor use of those EBIs and (2) adapt measurement feedback procedures to track and improve therapist utilization of EBIs. To achieve study aims the investigators will first partner with two community clinics to develop sustainable MTFS-I procedures using a three-phase Pilot process. Investigators will then initiate an experimental Trial during which therapists (n = 32, treating 192 clients) at four different clinics will be randomized to MTFS-I versus no-intervention Control. In both conditions two kinds of data will be collected: therapist-report checklists on use of core family therapy and CBT techniques with adolescent cases and treatment session audio recordings. MTFS-I uptake will be tracked electronically for online components (Aim 1: MTFS feasibility). Session recordings will be coded by observers for three facets of EBI fidelity: adherence (extent of EBI utilization), working alliance, and therapist competence. Observer ratings will measure the strength of EBI self-monitoring (Aim 2: therapist reliability and accuracy) and fidelity (Aim 3 \[EBI utilization\] \& Aim 4 \[alliance, competence\]). If effective, MTFS-I could be adapted to promote EBI fidelity for a variety of clinical populations and approaches.