23 Clinical Trials for Various Conditions
Poor parenting practices and compromised child self-regulation when a child is 2 ½ - 4 ½ years old are foundational in promoting their later healthy development and adaptive functioning. This project will test whether targeting depressive symptoms with a prenatal preventive intervention prevents disruptions in well-regulated parenting and child self-regulation known to affect families with depressed mothers. This project may have great benefit to society, as preventive interventions delivered prenatally have the potential to influence long-term trajectories of parenting practices and child development which, in turn, can chart a course for future child health and well-being.
The proposed study will examine two different intervention programs and whether they improve self-regulation of adopted children. The study is a small randomized controlled trial to test the feasibility of conducting a larger, R01-funded clinical trial. Outcomes will primarily be focused on feasibility concerns, such as recruitment and retention of a sufficient number of participants and implementation of treatment protocols with fidelity, as well as determining initial effect size estimates that might inform later power analyses and examining the functioning of developmental assessment measures when administered in the context of a clinical trial.
The goal of this study is to determine if progressively more challenging playground games (motor synchrony games) improve executive function in preschool-aged children.
This study evaluates feasibility and preliminary efficacy of a parent-based prevention program to promote social-emotional and lifestyle behavior health among 3- to 9-year-old children in families experiencing major stressors.
Scientific knowledge of the cognitive-developmental processes that serve to support children's appetite self-regulation are surprisingly limited. This investigation will provide new scientific directions for obesity prevention by elucidating cognitive-developmental influences on young children's ability to make healthy food choices and eat in moderation.
This study will evaluate whether the intervention, Mom Power, improves the self-regulation of mothers with a history of trauma and their children. The central hypothesis is that the intervention will shift behavioral and physiological self-regulation in mothers, children, and dyads to mitigate psychopathology risk.
The goal of "PLAY" is to adapt and test a developmentally appropriate intervention delivered on a mobile app to parents, with the goal of teaching fundamental motor skill (FMS) proficiency to their preschool-aged children (ages 3 to 5 y). Seventy-two children (3 to 5 y of age) were randomized. Of these children, 36 parents were randomized to use the FMS app and 36 were randomized to use a version of the app that promotes unstructured PA as a comparator group. Parents in the FMS condition accessed instructional lessons, peer modeling videos, and activity breaks to deliver 720 minutes of targeted, structured FMS instruction time to their child over a 12-week period. Parents in the comparator arm used a version of the app that provides instructional lessons to promote the equivalent amount of unstructured PA for their child. Parents were asked to guide the intervention, as parental support, modeling, and co-participation predict children's engagement in PA.
This study assesses the associations between genetic factors, food-cue-related neural reactivity, self-regulatory capacity, eating in the absence of hunger (EAH), and adiposity gain in children.
Children in rural communities experience significant obesity-related health disparities; they are 26%-55% more likely to be obese and less likely to have health insurance and access to weight management specialists than are their urban peers. Geographic-specific disparities in obesity may be due, in part, to variations in eating behaviors. Children in rural communities describe purchasing and consuming significantly more energy-dense, low-nutrient food items relative to their urban peers. Existing behavioral strategies for improving children's EI patterns have largely been ineffective in reducing risk for excess weight gain. The primary aim of the proposed study is to test the effects of a brief, novel strategy for improving rural children's eating behaviors. Specifically, the study aims to harness the well-documented benefits of an acute bout (20 min) of moderate physical exercise on children's executive functioning, and to see if these cognitive changes lead to better self-regulation of eating. If 20 min of moderate physical exercise is associated with observed improvements in preadolescent children's eating secondary to increases in executive functioning, these data may offer explicit targets for an obesity prevention trial in rural Oregon elementary schools.
The study is a multi-site, multi-level, and multi-component cluster randomized clinical trial (RCT) to address poor dental utilization (attendance) and untreated caries among 3-6 year old Medicaid-enrolled children attending well-child visits (WCV) in primary care settings. The focus is on addressing factors (determinants) at the socio-ecological levels of the child's environment: provider (pediatrician and nurse practitioner), practice/organization level, and parent/caregiver level. Eighteen practices will be randomized to 2 arms: A) bundled multi-level intervention consisting of: 1. training medical providers in the Common-Sense Model of Self-Regulation theory-based education so that the provider delivers to the parent/caregiver the following: i) Core oral health facts about dental caries, and ii) prescription to visit the dentist and a list of dentists accepting Medicaid; 2. Integration of oral health assessments into EMR for the provider to document in the child's medical record; versus B) Control arm of medical providers receiving the American Academy of Pediatrics (AAP) based oral health education and providing usual AAP-based care for oral health. Each arm will consist of 9 practices. Children will be followed for 24 months to determine dental utilization and changes in oral health status. The primary aim is to examine the effectiveness of theory-based behavioral (provider-level) and implementation (practice-level) bundled interventions versus enhanced usual care (AAP based oral health education) delivered by providers at WCVs in increasing dental attendance among 3-6 year old Medicaid-enrolled children. The secondary aims are to 1) assess the effectiveness of interventions on secondary outcomes (e.g. development of new caries, changes in oral hygiene, oral health quality of life, frequency of sweet snacks and beverages, cost), 2) assess potential mediators and moderators to investigate the pathways through which the multi-level interventions affect child primary and secondary outcomes, and 3) assess the adoption, reach, fidelity, and maintenance of providers and practices that affect child primary and secondary outcomes. The hypothesis is that theory-based behavioral (provider-level) and implementation (practice-level) bundled interventions delivered by providers at WCVs will increase dental attendance among 3-6 year old Medicaid-enrolled children versus enhanced usual care (AAP based oral health education) delivered by providers at WCVs.
The purpose of this study is to develop and pilot test a new type of patient-centered, family-based treatment for children aged 8-12 with obesity and their caregivers. The treatment will focus specifically on improving children's self-regulation (SR) skills to help them better manage their feelings, behaviors, and thoughts to help them live a healthier lifestyle.
The purpose of this study is to evaluate the use of Regulate and Gain Emotional Control (RAGE-Control), a biofeedback video game, in combination with brief instruction in relaxation skills as an intervention for symptoms of anger and aggression in children and adolescents. Half of the research participants will learn relaxation techniques and practice them using the RAGE-Control videogame. The other half of the participants will learn relaxation techniques and play a similar videogame without the biofeedback component. The investigators hypothesize that participants in the RAGE-Control group will show a greater reduction in symptoms of anger and aggression than those in the non-RAGE-Control group.
The study will compare the impact of Child STEPs versus usual school-based therapy on neural and companion behavioral measures of self-regulation.
The goal of this project is to measure childhood self-regulation targets known to be associated with obesity risk and poor adherence to medical regimens and to assess whether intervening on these mechanisms can improve self-regulation. The investigators will do so in a pre-existing cohort of low-income school-age children.
This study is a 12-week open-label trial to assess the effectiveness of Omega-3 fatty acids for deficient emotional self-regulation (DESR) as a supplement to Attention Deficit/Hyperactivity Disorder (ADHD) treatment in children and adolescents with Attention Deficit/Hyperactivity Disorder. Subjects will be between the ages of 6-17 and will currently be on medication for their Attention Deficit/Hyperactivity Disorder but still experience DESR traits.
The purpose of this project to determine whether the KITS Program, an intervention to improve early literacy, prosocial and emotion and behavior regulation domains of school readiness, improves school readiness and school outcomes in children from socioeconomically disadvantaged neighborhoods.
This study focuses on children entering kindergarten with co-occurring developmental disabilities and behavior problems, a population especially likely to have low levels of school readiness. Prior research has shown that children with developmental disabilities are at risk for academic difficulties. Behavioral and social problems are likely to interfere with school adjustment. The investigators hypothesize that children who receive the intervention will show better school readiness and school adjustment outcomes.
In this study the investigators will examine the Feeding Dynamic Intervention (FDI) as a tool to prevent obesity in young children. The purpose of the intervention is to improving caregiver feeding practices, child eating behaviors, and child self-regulation of energy intake in the short term.
The goal of this integrated project targeting the Childhood Obesity Prevention Challenge Area is to reduce the prevalence of obesity among children attending Head Start in Michigan. The proposed intervention program is based on Social Cognitive theory and the premise that enhancing children's capacity for emotional and behavioral self-regulation is a key component of effective obesity prevention. A randomized controlled trial design is proposed to evaluate, among 600 Head Start children and their parents, the effectiveness of 2 approaches to obesity prevention: (1) the Parents of Preschoolers Prevention Series (POPS), a curriculum delivered to preschoolers and their parents focused on obesity-related health behaviors; and (2) POPS in combination with the Incredible Years Series (IYS), an evidence-based program designed to improve preschoolers' emotional and behavioral self-regulation. The research objective is to test the hypotheses that: (1) POPS, compared to Usual Head Start exposure, will lead to greater improvements in obesity-related health behaviors and adiposity indices; and (2) POPS + IYS will lead to the greatest improvements in obesity-related health behaviors and adiposity indices, and this effect will be mediated by improved self-regulation. The extension objective is to evaluate the feasibility, fidelity, and educational effectiveness of the POPS and POPS + IYS interventions, as delivered by paraprofessionals and educators within Extension and Head Start. The education objective is to provide Extension and Head Start staff non-formal training and educational curricula which can be widely disseminated. The long-term goal of this project is disseminate a novel and effective approach to obesity prevention in preschoolers.
The goal of this clinical trial is to learn if mindfulness and yoga can improve attention, problem-solving, memory, emotional awareness, and impulsivity in preschoolers. The main questions it aims to answer are: Can a 30-minute, once-a-week mindfulness and yoga program (Calm \& Alert) over seven weeks in preschool classrooms increase emotional regulation during the school day? Can a 30-minute, once-a-week mindfulness and yoga program decrease negative behavioral incidences during the school day? Can a 30-minute, once-a-week mindfulness and yoga program increase prosocial behaviors like caring, sharing, and perspective-taking during the school day? Researchers will compare the effects of students who participated in the mindfulness and yoga program to students in classrooms who did not receive the program. Student participants will be asked to complete a short self-regulation task test before and after the mindfulness program. Teachers will rate the students on their prosocial behavior before and after the mindfulness program and record negative behavioral incidents over the study period.
The purpose of the proposed research is to conduct an efficacy trial of the Family Check-Up (FCU) Online to prevent emotional and behavioral disorders among middle-school students at-risk for disability during the transition back to school after the COVID-19 pandemic. Mental health and behavior problems are at epidemic proportions as a result of the COVID-19 pandemic, with the highest rates in adolescents and children with disabilities. We propose to evaluate the efficacy of the FCU Online, a school-based, ecological approach to family intervention and risk reduction, across a group of students at-risk or identified with disability during the middle school years. The FCU Online for middle school youth has been evaluated in a randomized trial in prior research during the development of the program but has never been tested as a large-scale, school-based intervention or delivered by providers working in schools. It has recently been adapted for COVID-19 and includes new modules on coping with stress and home-to-school engagement to support the return to school after COVID-19 for students at-risk. Students in schools will be identified for services using indicators that are natural to the school environment (attendance, office discipline referrals, and grades), and will be followed for 2 years. We predict that engagement in the FCU Online will be associated with student reductions in emotional and behavior problems, improvements in academic skills, and improvements in attendance. Parenting skills such as home-to-school communication, positive parenting, and behavioral routines will be tested as mediators of intervention efficacy.
It is clear that the COVID-19 pandemic has impacted families adversely in multiple ways, including economic stressors, mental health-related functioning, social/familial functioning, as well as responses to mandated safety measures (e.g. social distancing, stay-at-home orders, mask-wearing). Furthermore, families of school-age children have had to navigate online instruction and home schooling in the context of these difficult circumstances with little preparation for doing so effectively. School districts have varied widely in their ability to support parents during this crisis. These stressors are likely to have disproportionately adverse effects on lower-income and racial/ ethnic minority populations, for whom economic, academic, and family-level challenges were already pronounced. For instance, health effects of COVID-19 have hit African American and Latinx populations with disproportionate severity, including higher rates of hospitalization and death. Given the scale of pandemic impacts for families with school-aged children, the identification of effective family-focused interventions that target core mechanisms of change with a broad range of benefits for parents and youth across diverse populations, and that can be brought to scale rapidly and with fidelity, represent critical public health goals. In this research study the investigators will adapt and test the efficacy of the Family Check-Up Online as a treatment to foster resilient family functioning in response to the COVID-19 pandemic. The investigators will test the effects of the adapted FCU Online program on key mechanisms of change that are predicted to directly impact child and family functioning: parenting skills, parental depression, and parent and child self-regulation. The investigators predict that changes in these key targets of the intervention will impact participant's response to the COVID-19 pandemic, including youth depression and behavior problems, the ability to cope with pandemic-focused stressors, and social/familial functioning.
Stressful and traumatic experiences in childhood (Adverse Childhood Events, or ACEs) have been associated with poor health outcomes that extend into adulthood. When stress is sustained or severe in the absence of an adequate buffer, the stress response can become dysregulated--a state referred to as toxic stress. Some professional organizations have advocated for ACEs screening to be part of routine medical care. To date, however, no ACEs screening tool has been validated for use with children. Intervening early at critical points in the life course has the potential to allow a child to avoid the negative consequences of these adverse events. The proposed study has three overarching aims: (1) Examine the relationship between ACEs, stress biomarkers, and symptoms in children and caregivers over time; (2) Validate an ACEs screening in a pediatric health care setting; and (3) Test whether providing primary care-based preventive interventions for children with or at risk for toxic stress can lead to detectable changes in biomarkers, behavior, or health outcomes for children and/or caregivers.