162 Clinical Trials for Various Conditions
The RAINBOW study is a fully remote study focused on understanding and treating behavior problems in young children with tuberous sclerosis complex (TSC). The first goal is to enroll a group of 100 children with TSC between the ages of 3 and 6 years old, with and without problem behaviors, to learn about how best to measure behavioral challenges in TSC and how common these behaviors are during this age period. All families will get feedback from the clinical assessments collected. Eligible children who are experiencing behavior problems will be invited to enroll in a pilot clinical trial of internet-based Parent-Child Interaction Therapy (or PCIT), which is meant to help parents better manage their children's challenging behaviors. Adaptations to PCIT are incorporated to suit the needs of TSC children and families. Some participants will be randomly selected to receive the intervention immediately and others after a 6-month delay, but all families will receive the same intervention. Intervention sessions occur on a weekly basis for up to 20 weeks. Follow-up assessments, which include play interactions, parent interviews, and questionnaires occur about 3 and 6 months after the first visit. The delayed treatment group has an extra brief assessment about 12 months from the initial visit. This study will increase what is known about the types of behavior problems that come up during preschool age in TSC and how best to help children and families with TSC who are experiencing these problems.
In this project, the investigators aim to test the effectiveness of a mobile health (mHealth) system as a standalone versus coach-assisted intervention with the goal of achieving reach and scalability. Parents of children (ages 5-8) with disruptive behaviors (N = 324 subjects) will be randomly assigned to Group 1 (standalone app), Group 2 (coach-assisted app), or Group 3 (control app).
This project is a study funded by the National Institute of Child Health and Human Development to develop and pilot test an adapted parenting intervention to decrease excessive/inappropriate screen media use in young children with externalizing behavior problems.
There are very few treatments that are effective in reducing severe behavioral problems associated with autism. These behaviors include aggressive and self-harm behaviors, frequent repetitive behaviors and severe hyperactivity. This study is being conducted to determine whether cannabidiol can reduce any or all of these problem behaviors.
The Pro-Parenting Study seeks to determine the added benefit of targeting both parenting stress and parent management strategies to more effectively reduce behavior problems among children with developmental delay (DD). Findings from this study will improve the scientific understanding of evidence-based interventions for behavior problems among children with DD and the mechanisms underlying therapeutic change.
This study fills a notable gap in the transdiagnostic literature by evaluating whether an evidence-based transdiagnostic treatment for emotional disorders such as the Unified Protocol for Children (UP-C) is effective for treating childhood behavior problems.
The purpose of this study is to evaluate the effectiveness of PriCARE in decreasing child behavior problems and improving parenting capacity and skills at 4 primary care clinics in Philadelphia.
A significant minority of children (ages 5-12) display problematic sexual behavior and the persistence of this behavior is oftentimes as stable as other child behavior problems, such as aggression and defiance. Unfortunately, the only tested intervention protocols for these concerns utilize a group treatment modality that is not feasible in most community treatment settings. This project will define and pilot test an intervention for child sexual behavior problems that is applicable in most settings and can be easily disseminated as a first step toward validation in larger clinical trials.
The purpose of this research study is to learn whether or not a brief parenting program called Child Adult Relationship Enhancement (CARE) offered at a primary care office can help improve behavior problems in children who are 2-6 years old.
This is a double-blind, placebo-controlled crossover study to evaluate the safety and efficacy of glutathione alone or glutathione, vitamin C and NAC treatment in children with autism who also have severe behavior problems. The investigators hypothesis is that children with autism will show improvement in both learning capabilities and behavior with either glutathione, or glutathione, vitamin C and NAC therapy.
This study will determine the effectiveness of a combination of treatments in preventing behaviors that are typically associated with Attention Deficit Hyperactivity Disorder (ADHD) in young children.
This study will try to determine what causes learning, behavioral and emotional problems in children with chronic granulomatous disease (GCD) and other phagocyte disorders. (Phagocytes are a type of white blood cell.) Children with these disorders have frequent severe infections that require hospitalization, sometimes for long periods of time. Many of them also have problems with school, learning, behavior, anxiety and depression. This study will explore whether these latter problems are a direct result of the illness itself or are a consequence of frequent, long hospitalizations, or are due to other factors. Test findings in these children will be compared with those of children with cystic fibrosis-another disease that causes frequent infections requiring prolonged hospitalization. Patients age 2 or older with GCD or other phagocytic disorders or cystic fibrosis may be eligible for this study. Participants (or a parent or guardian) will complete questionnaires including personal information such as age, gender and marital status, a family medical history, and information on their illness. Patients will be given various psychological and intelligence tests, and they and their parents or guardians will be interviewed by a child psychiatrist. The tests and interviews take a total of about 5 hours and are given in two or three separate sessions. The tests may reveal problems such as learning disorders, attention-deficit hyperactivity disorder, anxiety, or depression. If any of these problems are identified, appropriate referrals will be made for specialized services, such as special school placement, tutoring, or counseling.
Many children born very preterm experience behavior problems, and existing resources for parenting these children are lacking. A pilot trial established the effectiveness of a preterm parenting intervention, I-Interact Preterm (I2P). This study proposes a three-arm randomized controlled trial (RCT) comparing the established seven-session I2P program, a microlearning delivery mode (I2P-Micro), and an internet resource comparison group (IRC). Outcomes will be assessed at pretreatment, post-treatment (12 weeks later), and at an extended follow-up six months post-randomization. These outcomes include parenting behaviors, child behavior problems, and parent distress. It is anticipated that both I2P and I2P-Micro will result in significant improvements relative to the IRC condition, with greater utilization expected in the I2P-Micro group.
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 primary objective of this study is to test the effects of an evidence-based prevention intervention (CPP) adapted for foster and kinship caregivers of young children (FC; foster care) on caregiver competence and child behavior problems for children in foster care compared with an active comparator group that receives standard supports through the child welfare and healthcare systems (i.e., usual care).
The primary objective of this study is to tailor the Chicago Parent Program, an evidence-based parent training program, for the foster care setting and pilot the content in two cohorts of foster and kinship caregivers (Gross et al., 2009).
Child and adolescent behavioral health problems are related to the leading causes of youth morbidity and mortality. Parent-focused preventive interventions, such as GenerationPMTO (GenPMTO), effectively prevent behavioral health problems such as depression and conduct disorders. Unfortunately, parenting programs are not widely available nor well-attended. Pediatric primary care (PC) is a non-stigmatizing setting with nearly universal reach and, therefore, an ideal access point to increase availability. However, PC personnel are not trained to address behavioral health topics. Also, typical referral practices are inadequate. There is a need to develop effective referral practices in conjunction with increasing availability. There are also logistical barriers to attending in-person parenting programs, like the need for childcare and a large time-commitment. There is a need to overcome these logistical barriers with more accessible programs. The long-term goal is to prevent significant behavioral health problems by increasing access to GenPMTO.
In a prior application (MH064372), the investigators' treatment research program (Services for Kids In Primary-care, SKIP) developed and tested a chronic care model-based intervention, called Doctor Office Collaborative Care (DOCC), that was found to be effective in the management of childhood behavior problems and comorbid ADHD. In the "SKIP for PA Study", the investigators propose to conduct a randomized clinical trial to evaluate the effects of team- and practice leadership-level implementation strategies designed to enhance the use and uptake of DOCC in diverse pediatric primary care offices.
This study aims to compare the efficacy in delivering two evidence-based parenting programs to families and young children experiencing homelessness. Outcomes evaluated include feasibility, treatment completion, treatment satisfaction of delivery of interventions as well as child outcomes (e.g., behavior problems, trauma symptoms) and parenting outcomes (parenting stress and parenting skills).
Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS) is an evidence-based approach for teams that can be adapted for school mental health. TeamSTEPPS has been widely disseminated in health care settings with promising outcomes. TeamSTEPPS is designed to build competencies in the areas of leadership, situation monitoring, mutual support, and communication and has been associated with improvements in teamwork and communication as well as patient outcomes, such as decreased seclusion in psychiatric hospitals. This approach has yet to be extended as an implementation strategy in school or community mental health teams. If an evidence-based team approach like TeamSTEPPS can be successfully applied to school mental health teams, it could provide a cost-effective strategy for improving student mental health services and bolstering existing EBP implementation efforts, which to date generally have been insufficient in producing long-term clinician behavior change. In Aim 1 the investigators will capture key stakeholder perspectives about challenges in collocated school mental health services through formative work to inform collaborative planning and capacity building activities in Aim 2. Then, in Aim 2 the investigators will identify inter-organizational challenges and required components of TeamSTEPPS to adapt. The investigators will establish an advisory board and adapt TeamSTEPPS. The product of Aim 2 will be an adapted TeamSTEPPS, directed toward both school mental health and school-employed personnel, and specific, tailored implementation strategies to improve services in schools in conjunction with TeamSTEPPS. Finally, In Aim 3 the investigators will explore the feasibility, acceptability, and utility of TeamSTEPPS and the strategies generated in Aim 2 on inter-professional collaboration, teamwork, and student outcomes in eight schools.
The purpose of this study is to evaluate the efficacy of the enhanced PriCARE intervention in improving parenting capacity, decreasing child behavior problems, and reducing risk of child maltreatment at several primary care clinics in Philadelphia and 2 primary care clinics in North Carolina.
The purpose of this study is two-fold: 1) to examine the feasibility of the Drop-In model of Family Nurture Intervention (FNI); and 2) to collect pilot data concerning the mother's response to the Drop-In model of FNI and short term effects of participation. Feasibility of the Program will be measured through costs, staffing, space availability, and uptake. Participation in the Drop-In entails weekly visits for FNI. The investigators hypothesize that the Family Nurture Intervention will show feasibility through attendance and positive response to the Drop-In format. The investigators also expect the Family Nurture Intervention to improve mother's perceived well-being and mother-child emotional connection.
The purpose of the study is to evaluate early implementation outcomes of a positive parenting program, Child Adult Relationship Enhancement in Primary Care (PriCARE), in the foster care setting and to assess the efficacy of PriCARE in promoting positive parenting and increasing empathy among foster caregivers.
Does Family Centered Treatment (FCT) result in better youth, family, and cost outcomes, as compared to a Level II or Level III out-of-home placement (OHP)? The investigators test the hypotheses that among children/youth authorized to a Level II or Level III out-of-home placement, relative to youth who receive such a placement, those who receive FCT will have: * Better: family functioning and mental/behavioral health outcomes (youth and caregiver). * Lower probability of: being subject of a child protective services report, entering (or re-entering) foster care, being arrested, being retained in grade, being chronically absent (missing \>15 days), dropping out of high school, or receiving an out-of-home placement. * Lower cost of care.
The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral, and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.
There are two aims of this study (a) to examine the effect of Teachers and Parents as Partners on student, parent, and teacher outcomes in middle school and (b) identify barriers and facilitators to implementing Teachers and Parents as Partners in middle school for students with behavior concerns.
The purpose of this current study is to investigate the efficacy of a group model of Family Nurture Intervention in ameliorating behavioral problems in preschool-aged children. The behavioral, neurobiological and clinical insights gained from this project may eventually lead to better treatment of emotional, behavioral and developmental disorders. The investigator hypothesizes that the children who are treated with Family Nurture Intervention (FNI), which incorporates interactive touch with vocal soothing, and family practice in comforting, will show increased emotional connection and mother child co-regulation with better results in the outcome measures in the short term and long term.
Specific Aims: 1. The primary aims of this study are to conduct formative interviews with teen mothers to inform a targeted adaptation of empirically based weight management and parent training programs for teen mothers for their preschoolers. 2. To conduct a small pilot and post-pilot focus group of the feasibility and acceptability of recruitment and retention methods \& the intervention. Study Hypotheses: Given the small sample size and fact that this is a pilot study, focus will be on estimating effect sizes rather than statistical hypothesis testing. However, the investigators exploratory hypotheses are as follows: 1. (a) The adapted intervention will be more feasible compared to the wellness control condition, with a participant retention rate of ≥80% and an average adherence (attendance at weekly treatment sessions; homework completion 5 weekdays weekly) is ≥ 75%; (b) The adapted intervention will be more acceptable compared to the wellness control condition, based on the Consumer Satisfaction Scale and Therapy Assessment Inventory with ≥90% of the participants responding to the item, "In general how satisfied were you with the intervention?" by choosing "unsatisfied" to "very satisfied." 2. (a) The adapted intervention will result in greater improvements in child behavior and parent-child connectedness compared to the control condition; (b) the adapted intervention versus wellness control condition will result in greater increases in child and teen mother individual as well as joint physical activity and physically active play and greater reductions in individual and joint teen mother and child sedentary behavior (television viewing) from baseline to post-intervention; (c) the greater teen mother and child fruit and vegetable consumption; and reduced child juice and sugar-sweetened beverage consumption from baseline to post-intervention; (d) the adapted intervention versus wellness control condition will result in smaller increases in child BMI percentile and teen mother BMI from baseline to post-intervention; (e) participants who attend higher numbers of intervention sessions will show greater improvements in target outcomes (child behavior, parent-child connectedness, and teen mother and child physical activity, sedentary behavior and BMI); with participants receiving the adapted intervention versus wellness control showing the greatest dose-based improvements.
Evidence-based programs aimed at enhancing parenting skills are effective, and pediatricians identify many parents who could benefit from such programs. Low-income children have high rates of behavior problems and their family system and environmental exposures often lead to cumulative and daunting levels of risk for poor functional outcomes; their parents are highly likely to benefit from parenting supports. However, low-income families are the most likely to drop out of parenting interventions, meaning the families and children with the greatest need receive the least support. Fewer than 25% of low-income families recruited to parenting programs will participate in even one session, and only about half of these parents will participate in more than half of the sessions offered. The aims of this trial are: Aim 1: To test the hypothesis that the provision of motivational interviewing (MI), as compared to an attention control (AC) condition, will increase the engagement of low-income parents of preschoolers in an evidence-based parenting skills group (the Incredible Years Series (IYS)). For this study, the outcome of engagement is operationally defined as intention to attend IYS sessions, attendance, and satisfaction with the IYS program. Aim 2: To test the hypothesis that the effect of MI on engagement in IYS will be impacted by the following moderators: parenting self-efficacy, child behavior problems, and maternal depression. The investigators hypothesize that the effect of MI on engagement will be greater among parents with lower parenting self-efficacy and parents of children with more behavior problems, but less among parents with more maternal depressive symptoms. The investigators will use a stratified, randomized controlled trial (RCT) design to evaluate the impact of MI on parent engagement in a well-validated preventive parenting skills intervention, the Incredible Years Series (IYS).
The purpose of this study was to determine whether ParentCorps promotes academic achievement and prevents mental health problems in children living in disadvantaged urban communities