37 Clinical Trials for Various Conditions
The study will utilize a stepped wedge cluster randomized design to examine the effectiveness of the full FaCES (Facilitating Change for Excellence in SBIRT) adolescent SBIRT change package. Primary care providers will be randomized as to when they receive training and begin delivery of FaCES with their 12 to 17 year old patients, which includes targeted feedback based on the patient's endorsed substance use level on the S2BI screening instrument.
The North Carolina Immunization Branch will evaluate the use of the CDC program to improve adolescent vaccination practices (called Assessment, Feedback, Incentives, and eXchanges, or AFIX). This evaluation is the first of its kind in the nation and may have a profound impact on prevention. AFIX has four major components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. This program will evaluate the effectiveness of AFIX visits on affecting provider practices to increase adolescent (age 11-18) immunization. Visits include discussion of that practice's immunization rates and strategies for improving rates. The investigators will compare the changes, from baseline to 5 months, in immunization for practices receiving virtual visits (webinars), in-person visits, and no visits (control group). Thirty practices will be randomly assigned to each intervention type. The main outcomes of this study are practice-wide uptake rates of several adolescent vaccines (Tdap, HPV, and MCV4) as well as pre- and post-AFIX visit surveys focusing on recall tactics utilized by each practice. Data will be collected on practices with at least 200 adolescent patients (note: there is no patient-level data collected in this study).
The safe, highly-effective human papillomavirus (HPV) vaccine remains underused in the US; only 51% of 13- to 17-year-old girls and boys were up-to-date by 2018. The Announcement Approach Training is effective in increasing HPV vaccine uptake during the clinic visit by training providers to make strong vaccine recommendations and answer parents' common questions. Systems communication like recall notifications also improve vaccination by reducing missed clinical opportunities. Although never tested to support HPV vaccination, the ECHO (Extension for Community Healthcare Outcomes) Model is a proven implementation strategy to promote capacity exchange between health care experts at academic centers and primary care providers at the front line of rural community health care. The trial will test the effectiveness of two ECHO-delivered HPV vaccination communication interventions versus control: HPV ECHO will provide Announcement Approach training, and HPV ECHO+ will provide training plus recall notices to communicate with parents who initially decline vaccination.
The University of North Carolina will test the effectiveness of the Centers for Disease Control and Prevention's AFIX model for increasing HPV vaccination coverage among adolescents. AFIX (Assessment, Feedback, Incentives and eXchange) consists of brief quality improvement consultations that immunization specialists from state health departments deliver to vaccine providers in primary care settings. Using immunization registry data, the specialist evaluates the clinic's vaccination coverage and delivers education on best practices to improve coverage. We will compare changes in HPV vaccination coverage before and after consultations for high-volume pediatric and family medicine clinics across three study conditions: traditional consultations (in-person group), virtual consultations (webinar group), or no consultations (control group). In each participating state, 30 clinics will be randomly assigned to each study arm, for a total of 90 clinics per state, or 270 clinics overall. The primary objective of this study is to compare the change in coverage for HPV vaccine initiation among 11-12 year old patients, from baseline to 6-month follow-up. Secondarily, we will compare the change in coverage for other vaccines and age groups.
This trial will evaluate a multi-component, clinic-based intervention aimed at increasing dual protection strategy selection and adherence among young African American females at an urban family planning clinic. Dual protection is the use of contraceptive strategies to prevent both unintended pregnancy (UIP) and sexually transmitted infections (STIs). This is an unblinded randomized controlled trial; participants will either get the interactive multimedia platform focused on DP strategies with intervention arm counseling or the standard of care arm counseling. The study will recruit 710 African American females aged 14-19 who are attending the Grady Health System (GHS) Teen Services Clinic (TSC) in Atlanta, Georgia, for reproductive health care. The trial will recruit and enroll 710 young women presenting to the clinic for clinical care who have the following characteristics: * self-identify as African American, * 14-19 years of age, * have had vaginal sex with a male partner in the past 6 months, * HIV-negative by self-report, * not pregnant,verified by urine pregnancy test, * no desire to be pregnant in next 12 months, * plan to stay in the Atlanta area for the next year, * are willing to provide contact information, and * were not previously enrolled in the pilot study of this intervention. Those enrolled will be in the study for 12 months. Young women who are eligible and give written consent or assent for study participation will be enrolled. Half will be randomized to the control arm, half to the intervention arm. 1. Control arm (standard of care) includes individual clinical care and standard of care counseling consistent with protocols at the TSC, with study visits for data collection at enrollment, 6 months, and 12 months, during which any medical care or counseling that they would normally get will also be provided. Control arm participants will also get telephone calls from clinic staff to update their contact information and remind them of upcoming visits at 3 weeks and 5 months after the enrollment visit, and at 3 weeks and 5 months after the 6 month visit. 2. Intervention arm, consisting of the following intervention components: 1. Enrollment visit * A culturally-appropriate interactive multimedia platform focused on DP strategies and designed to prepare the individual for selection of a DP strategy. * Individual intervention arm counseling to select the DP strategy that is best suited for the participant (by a clinic health care provider). * Individual intervention arm counseling to build skills for correct and consistent use of the selected DP strategy (by a nurse educator (NE)). 2. Booster counseling via phone at about 3 weeks and 5 months after the enrollment visit, and at about 3 weeks and 5 months after the 6 month visit (by an NE). 3. 6 month visit * An abbreviated version of the interactive multimedia platform focused on dual protection strategies and strategy adherence. * Individual intervention arm counseling to reinforce skills for correct and consistent use of the DP strategy (by an NE). At the final study visit at 12 months there is no difference between the counseling provided to the two groups; participants in both arms will receive the clinic standard of care. Participants in both arms of the study will follow the same data collection procedures throughout the study: * At all three study visits, participants in both arms will receive urine pregnancy and STI tests and complete an audio computer assisted self-interview (ACASI) questionnaire. * At 3 and 9 months after enrollment, participants in both arms will receive a data collection call with administration of a telephone questionnaire. Throughout the study, all participants will be encouraged to come in for evaluation if they have any concerns. Any data from pregnancy or STI testing at these interim clinic visits will be later collected via chart review. If participants seek reproductive health care at other facilities during the study period, records will be requested with participant permission, and data from pregnancy or STI testing at these outside clinic visits will be collected via review of records received. We will examine the efficacy of the intervention arm relative to control arm across the following primary behavioral and biologic outcomes over the 12 months of follow-up: 1. Self-reported dual protection strategy selection 2. Self-reported dual protection strategy adherence 3. Incidence of pregnancy or infection with chlamydia, gonorrhea or trichomonas (as confirmed by laboratory testing) A small pilot study was be conducted prior to the initiation of enrollment in the main study.
The primary aim of this study is to determine the feasibility and acceptability of the W-GenZD mobile application among a group of adolescents and who have screened and triaged into low-intensity treatment within the Children's Hospital of the King's Daughters. The secondary aim of this study is to determine the preliminary comparative efficacy of W-GenZD and CBT-light teletherapy zoom groups to manage mood concerns at 4-weeks end of treatment relative to baseline. The third aim of this study is to investigate potential differences between group differences on working alliance. An exploratory aim of this study is to observe and describe the utilization and outcomes of the safety procedures utilized within this study.
This project, Refining and Implementing Technology-Enhanced Family Navigation to Promote Early Access and Engagement with Mental Health Services for Youth with Autism (ATTAIN NAV) is focused on adapting and implementing family navigation in primary care settings to help accelerate and facilitate engagement in mental health and community services for children with autism and their families.
This study will provide new and important information regarding parental knowledge and attitudes of confidential STI and related health care services (prevention, diagnosis and treatment) for teens that may be needed to address the STI epidemic. Using both qualitative and quantitative methods, this study will gather information necessary to develop effective interventions aimed at the often neglected parent component of the teen-parent-health care provider partnership by giving parents knowledge and skills to help them facilitate their adolescent's access to confidential STI services as needed.
The EASE program is an existing, evidence-based program/intervention (originally developed by the WHO), and this study is limited to evaluating the local implementation of this program. The aims of this pilot study are to: * Assess the acceptability and feasibility of training and supervision of EASE Helpers (community staff members) through an adapted EASE training. * Evaluate possible problems of recruitment, intervention delivery, and participant retention. * Assess the feasibility of EASE being delivered via a partnership between researchers and community members. * Evaluate implementation of EASE via the RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) framework A mixed-methods design with qualitative and quantitative approaches will be used to assess these objectives.
The goal of this clinical trial is to learn if this intervention (Social Skills, Problem Solving, emotion Regulation, and psycho-Education on Trauma: A Trauma-Informed Peer Aggression and Teen Dating Violence Prevention Program; SPARE) can treat peer aggression and prevent teen dating violence in preteens receiving intensive mental health services. The main questions it aims to answer are: * Does receiving SPARE reduce proactive and reactive aggression at post-intervention and 3- and 9-month follow-ups? * Does receiving SPARE reduce positive attitude about TDV, prevent TDV behaviors, and improve mental health outcomes at post-intervention and 3- and 9-month follow-ups? Researchers will compare youth receiving SPARE to youth receiving treatment as usual to see if SPARE results in improved proactive and reactive aggression, TDV attitudes and behaviors, and mental health outcomes. Participants will: * Receive SPARE via group therapy incorporated into their daily programing at an intensive mental health program * Complete study questionnaires at program intake and discharge as well as at 3-month and 9-month follow-up assessments
The goal of this clinical trial is to evaluate an app to help keep teens and young adults with suicidal thoughts safe. The app includes a safety plan created by adolescents and healthcare providers in the clinic, and videos to encourage supportive communication and skills for teens and young adults to stay safe. The main question it aims to answer is whether the use of an app can increase youth suicide-related coping for youth with suicidal ideation, parent suicide prevention self-efficacy, and healthcare provider self-efficacy in suicide management. Researchers will compare usual care to usual care with the app. Participants, including adolescents, their caregivers and healthcare providers, will use the ISSP app (if assigned to that group) and complete three online surveys.
The MoodRing intervention is a mobile application for adolescents, parents, and an accompanying web-based clinician portal which enables adolescents to monitor their mood through the use of passively collected smartphone data. This randomized controlled trial will evaluate whether MoodRing as compared to usual care improves the quality of depression management.
The proposed research project provides a novel approach to screening, early assessment, and preventive interventions for high-risk youth in racial/ethnic/linguistically (REL)-diverse communities. * The investigators assess a health promotion intervention as a way of reducing treatment disparities in REL-minority youth. This population is underrepresented in child psychiatry research. It is often excluded from clinical trials of medication or therapy because of challenges with transportation, literacy, resources, or other issues. * The study will take place during or following a healthcare crisis and economic recession, making findings relevant to understanding the mechanisms by which hardship translates into youth mental illness. * The innovative integration of online screening into school-based clinics and community-based settings in REL-minority communities is made possible by the combination of access to a new technology (CAT) in the context of a learning health community serving a REL-minority population. * Empirical research on the impact of a resilience-based prevention intervention in youth and youth at risk is both innovative and much needed during this period of health, social and economic crisis.
Opioid addiction, also referred to as opioid use disorder, among young people is a growing health concern for patients and their families. Overdose deaths related to opioids have been steadily increasing in number and are at an all-time high. Opioid addiction has serious consequences such as getting HIV, legal problems, relationship problems, and unemployment. Currently, there are two standard of care office-based medications available to treat opioid use disorder, buprenorphine and naltrexone. Naltrexone has been available for several years as an extended-release monthly injectable formulation, and more recently buprenorphine is as well. Both of these medications are typically administered in the medical office setting. Long-acting injection medications like these help people that may otherwise forget doses, skip doses, and relapse. MAT that are FDA-approved such as these paired with counseling can help sustain recovery, but retention to treatment is a concern, especially among young adults. Many barriers arise for attending office-based treatment (e.g., transportation) often resulting in falling away from treatment and relapsing. Involvement of family members is often challenged by health care provider concerns about patient privacy, and existing relationship strain between patients and their families. The Youth Opioid Recovery Support (YORS) treatment delivery model hopes to address barriers to retention to substance treatment among those with opioid use disorder who have already decided to get treatment with either extended-release naltrexone or extended-release buprenorphine. The YORS model involves: 1) home-delivery of standard-of-care medication and individual/family counseling services; 2) assertive outreach efforts by the treatment team; and 3) contingency management incentives upon receipt of treatment. This service model has already shown promise in addressing barriers to treatment retention particularly difficulties with medication adherence in patients who were prescribed monthly injectable extended-release naltrexone. Now that extended-release buprenorphine is also available, broader MAT options provided in an assertive service delivery model may maximize treatment retention and recovery outcomes. Further, transitioning participants from home-based receipt of treatment to clinic-based care begins the translation to sustainable health care.
The trial studies the efficacy of subcutaneous (SQ) testosterone compared to intramuscular (IM) testosterone therapy during the first 6 months of pubertal induction in transgender male adolescents. Describes rate of adverse effects, masculinizing effects and quality of life while receiving testosterone. Evaluates clinic utilization required for testosterone therapy.
The aim of the study is to improve access to child mental health and substance abuse (MH/SA) care by expanding primary care screening and increasing availability of timely mental health evaluation and treatment.
The purpose of this pilot study is to provide preliminary findings testing the Supporting Our Valued Adolescents (SOVA) intervention, two social media sites (one for adolescents, one for parents) aiming to address negative health beliefs, knowledge about depression or anxiety, parent-adolescent communication, in a moderated online peer community, with the goal of increasing adolescent use of mental health services.
The study will compare the impact of Child STEPs (see Weisz et al., 2012) versus usual school-based therapy on students' mental health and school-related outcomes, and test whether changes in school outcomes are mediated by changes in student mental health.
The purpose of this study is exploring a theoretically guided intervention, Cornerstone, which provides system 'boundary-spanning' services, including therapeutic services and mentorship, to transition-age youth with mental disorders. Cornerstone is designed to improve mental health service engagement and outcomes. The study uses a mixed methods approach to refine Cornerstone, and a hybrid design examining feasibility, acceptability, and preliminary impact with a randomized trial, alongside implementation.
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.
This community-partnered participatory study will work within high school health centers (SHCs) to test, via a 2-armed cluster randomized controlled trial, a multi-level intervention to reduce adolescent relationship abuse (ARA) among adolescents ages 14-19. The goal of this study is to examine the effectiveness of the School Health Center Healthy Adolescent Relationships Program (SHARP) intervention in SHCs on individual SHC clients, the SHC clinic environment, and the schools in which the SHCs are located. Evaluation of the intervention will involve random assignment of eight comparable SHCs in the Greater Bay Area of California that provide comprehensive health services, to either intervention or control sites. Adolescent females and males ages 14-19 seeking care at any of these SHCs (N=1200) will be assessed via audio computer-assisted survey instrument (ACASI) at baseline and 16-20 weeks follow-up to examine intervention effects on knowledge and self-efficacy regarding ARA, harm reduction and ARA-related resources as well as intentions to intervene with peers. For youth reporting recent ARA victimization, the investigators will assess for increases in ARA disclosure, resource utilization, as well as reduction in ARA victimization.
The study will evaluate a health services intervention to increase uptake of adolescent vaccines (HPV, Tdap, meningococcal conjugate, and influenza) among students enrolled in five school health centers by improving the consent process for parents.
This project's focus is twofold-to change the culture of an employment training program for adolescents and young adults (Youth Opportunities, or "YO") to more fully address the many mental health issues faced by its participants and to expand and improve the quantity and quality of mental health services for YO members. Four project components have been carefully selected to address the mental health issues of YO members: (1) Mental health education/training for YO staff and peer leaders, (2) Mental health education activities for YO members, (3) mental health screening on all newly enrolling YO members, and (4) comprehensive mental health services for YO members. These project components will be implemented at the HEBCAC YO Program (subsequently referred to as "Eastside" YO), with the Westside YO Program initially participating as a control site. Researchers at the Johns Hopkins University Center for Adolescent Health, led by Dr. Darius Tandon of the Department of Pediatrics, will conduct the research examining the effectiveness of these mental health services and supports. There are four project objectives. First, the proposed activities will increase YO members' knowledge of mental health resources and decrease stigma associated with seeking mental health services. Second, the investigators will see an increase in YO members' receipt of needed mental health services. Third, the investigators will see improvement in YO members' mental health. Fourth, as a result of their improved mental health, YO members will more actively engage in YO program activities and achieve more key program milestones (e.g., GED completion). These objectives are sequential, with later objectives predicated on the achievement of earlier ones.
The purpose of this study is to help improve our understanding of when and why adolescents decide to use alternative and complimentary medicines, and to understand factors that lead to better communication between youth and their clinicians.
The purpose of this study is to test the effectiveness of a family-centered, community-based, self-management intervention (Self-Management Therapy) for adolescents with schizophrenia. The study will test the intervention's effectiveness in improving the adolescents' behavior, thinking, mood, and use of substances such as drugs and alcohol. The study also will look at the effects of the patient on the family. The intervention involves training in recognizing symptoms of schizophrenia and in stress management, problem-solving, and social skills. Parents and siblings are included to gain knowledge and skills to support the adolescents. The Self-Management Therapy intervention is administered in small multiple-family groups in 12 sessions over 7-1/2 months. The effects of the intervention on the patient and his/her family are assessed prior to treatment, after 6 sessions, after 12 sessions, and in a follow-up visit 6 months after completion of sessions. A child may be eligible for this study if he/she: Is 15 to 19 years old and has been diagnosed with schizophrenia.
Randomized controlled trial to determine the best brief suicide prevention intervention for adults and adolescents who screen positive for suicidal ideation or behavior in emergency departments or primary care clinics. Aim 1: Compare the effectiveness of two brief suicide prevention interventions (safety planning intervention plus structured phone-based follow-up from a suicide prevention hotline (SPI+), versus safety planning intervention plus caring contacts (CC)) to (a) reduce suicidal ideation and behavior, (b) reduce loneliness, (c) reduce return to care for suicidality, and (d) increase uptake of outpatient mental healthcare services over 12 months among adult and adolescent patients screening positive for suicide in emergency departments (EDs) and primary care clinics. Aim 2: Assess the acceptability of connection and support planning and the safety planning intervention, with or without follow-up among providers and clinical staff in EDs and primary care clinics. Aim 3: Assess the acceptability of SPI+ and SP+CC among adult and adolescent patients.
The overarching goal of this study is to evaluate the effectiveness, cost-effectiveness and sustainability of utilizing statewide Immunization Information Systems (IIS) to conduct centralized reminder/recall (R/R) to improve Human Papiloma Virus (HPV) vaccination rates among adolescents ages 11-17 (with a more focused look at the new two dose series for 11-14 year olds).
The purpose of this study is to examine participant adherence to intervention feasibility and acceptability of intervention, attention control, and implementation strategy.
Functional abdominal pain (FAP), a pediatric pain condition without significant organic pathology, is a precursor to chronic pain and high healthcare utilization in young adulthood. This project aims to identify child and family characteristics that predict differential responses to a Cognitive Behavior Therapy intervention administered online to patients with FAP and their parents. The goal is to acquire scientific knowledge to guide individualized treatment of patients with FAP.
The primary goal of this study is to examine the impact of varying supervision strategies on clinician fidelity and client outcomes in a community-based setting. Prior research has established that training approaches that do not include a period of intervention-specific supervision or consultation are ineffective and that implementation efforts that include only an initial period of supervision show an eventual attenuation of gains in knowledge and fidelity in practice. Ongoing supervision may be required for effective and sustained implementation of evidence-based practices (EBPs) in community-based settings. However, supervision is one of the least investigated aspects of training. "Gold standard" elements of supervision from efficacy trials include review of sessions, standardized procedures for monitoring client outcomes and model fidelity, and ongoing skill-building (e.g., behavioral rehearsal). The degree (e.g., frequency, intensity) to which these strategies are used in community-based settings is unknown. There are a growing number of national and statewide efforts to increase the reach of EBPs through dissemination and implementation initiatives. There are 18 statewide initiatives to implement Trauma-focused Cognitive Behavioral Therapy (TF-CBT), an EBP for child trauma exposure and sequelae. Many of the community based TF-CBT implementation efforts, and those for other EBPs, include a specific focus on supervisors. However, the limited scientific literature provides very little guidance for these efforts. Aims of the current trial include 1) studying supervision with existing implementation supports; particularly presence of gold standard elements; 2) evaluating the effects of varying supervision strategies on fidelity and client outcomes; and 3) testing the mediating effect of treatment fidelity on the relationship between supervision type and client outcomes. We propose a two-phased, within-subjects and between subjects design. In Phase I (9 months), we examined supervision with implementation support. In Phase II (30 months), we will examine two specific supervision conditions, each including varying EBP supervision elements.