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Showing 1-20 of 73 trials
NCT07579403
This clinical trial had two objectives. The first was to compare the effectiveness of 950 ppm fluoride toothpaste versus probiotic toothpaste in preventing dental caries in 4- to 5-year-old children. The second was to understand how children's oral hygiene habits and dietary habits influence the development of dental caries. The main questions it aimed to answer are: * Does fluoride toothpaste reduce new caries more than control toothpaste? * Does probiotic toothpaste reduce new caries more than control toothpaste? * Which oral hygiene and dietary habits are risk factors for dental caries? Researchers compared fluoride toothpaste and probiotic toothpaste to a control toothpaste (without active ingredients). Participants were asked to complete the following tasks: * Complete a questionnaire about their oral hygiene and dietary habits at baseline * Undergo oral health examinations at baseline and after 12 months * Brush their teeth twice daily (morning and before bedtime) with their assigned toothpaste for 12 months * Use a pea-sized amount of toothpaste each time * Brush under the supervision of parents to ensure brushing quality
NCT03910491
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.
NCT07209696
This study is designed to evaluate strategies for reducing dental anxiety in pediatric patients. The commonly applied "Tell-Show-Do" method involves explaining and demonstrating dental procedures before they are performed. In this randomized controlled trial, three groups of children will be compared: Children who receive only the Tell-Show-Do method, Children who are prepared at home with a storybook prior to receiving the Tell-Show-Do method, Children who are prepared at home with an animation video prior to receiving the Tell-Show-Do method. Children's dental anxiety will be assessed using validated behavioral observation scales, including baseline measurement at the first examination, after preparation, and following completion of dental treatment. The study will determine whether the addition of a storybook or an animation video provides greater effectiveness in reducing dental anxiety compared with the Tell-Show-Do method alone.
NCT07433361
Interventions that promote safe, stable, and nurturing relationships between caregivers and children are key to improving healthy family relationships, reducing child socioemotional and behaviour problems, and preventing child maltreatment. Although a broad range of parenting programs are currently implemented in communities across Ontario, most programs are inadequately evaluated, or else not evaluated at all using a pilot pragmatic Hybrid Type II individually randomized controlled trial conducted within routine service settings. The trial will enroll 300 families in Ontario, Canada. The evaluation is informed by the RE-AIM framework, with a primary emphasis on Reach and Implementation and secondary examination of Effectiveness, consistent with the objectives of a Hybrid Type II design.
NCT04946253
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.
NCT07387133
This study aims to examine the relationship between parental technoference (parents' use of smartphones or other digital devices while spending time with their children) and behavioral and emotional development in early childhood. The study will include parents of children aged 24 to 60 months who attend a pediatric outpatient clinic. At the beginning of the study, parents will complete an online questionnaire that includes questions about their own smartphone screen time, their child's screen exposure, and standardized questionnaires assessing parental technoference and children's behavioral and emotional characteristics. Six months after the initial assessment, parents will be contacted again to complete a short follow-up questionnaire, including the behavioral and emotional assessment. The study does not involve any medical intervention or experimental treatment. All participation is voluntary, and responses will be collected anonymously. The findings of this study are expected to contribute to a better understanding of how parental digital device use during daily interactions may be associated with children's emotional and behavioral development in early childhood.
NCT05729945
This study involves a long-term outcome study of the Catholic Health Initiative St. Joseph's Children (CHI SJC) program using a randomized control study. The purpose of this study is to determine the short-term and long-term impact and effectiveness of the CHI SJC program. The CHI SJC program has not been studied to determine program effectiveness. The investigators intend to follow families and their children until the children in the study graduate from high-school or turn 19 years of age. The study, as a template, uses the eight outcome domains listed and described in the Home Visiting Evidence of Effectiveness website (http://homvee.acf.hhs.gov/outcomes.aspx). These eight domains are: * Child development and school readiness * Family economic self-sufficiency * Maternal health * Reductions in child maltreatment * Child health * Linkages and referrals * Positive parenting practices * Reductions in juvenile delinquency, family violence, and crime The investigators expect to observe significant differences among the two groups with respect to the primary outcome domains listed. The investigators expect study group members randomized to the CHI SJC program will perform better on the eight outcome domains. Other hypotheses include: Other Hypotheses: Hypothesis 1. Randomization to CHI SJC will be associated with higher quality functioning and better child health and well-being. Hypothesis 2. Randomization to CHI SJC will result in more connections to community resources. Hypothesis 3. Randomization to CHI SJC will result in improved indications of maternal health and positive parenting practices. Hypothesis 4. Randomization to CHI SJC will be associated with higher measures of family economic self-sufficiency. Hypothesis 5. Randomization to CHI SJC will be associated with increased school readiness and school progress and attainment. Hypothesis 6. Randomization to CHI SJC will be associated with reductions in juvenile delinquency, family violence, and crime. The study will collect outcome data in the same way and, at the same time, from treatment and control group members. Data collection will primarily be comprised of a set of self-report questionnaires and a review of administrative records that target the outcome domains described earlier. Study group members will be assessed at baseline, 6 months, 12 months, 18 months, 24 months, 3 years, 5 years, 8 years, 12 years, 15 years, and at high-school graduation or 19 years of age.
NCT06163703
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.
NCT04909203
This study is a 16-week intent-to-treat randomized controlled trial (RCT) with 120 suicidal juvenile justice (JJ)-involved transition-age (TA) youth (age 15-21 years) and a primary caregiver (dyads). Dyads will be randomly assigned to iKinnect2.0 (n=60 dyads) or Life360 (control app) plus an electronic suicide resources brochure (n=60 dyads). This design will test iKinnect2.0's new features for suicide prevention against TA youth awareness of and access to high-quality suicide prevention resources, while simultaneously testing features relating to conduct problems and parent management against parents knowing the TA youth's whereabouts in real-time and controlling for dyad member engagement in technology (Life360). Participants will be assessed at baseline, 4, 8 and 16 weeks. Primary youth-reported outcomes relating to suicide risk include: Suicidal behaviors (ideation, planning, attempts), non-suicidal self-injurious behaviors, self-efficacy in coping with distress, and use of imminent distress coping strategies (behavioral skills, use of crisis stabilization plan). Youth will also report on their criminal behavior. Primary caregiver-reported outcome variables relating to youth suicide include: Self-efficacy in applying family-based suicide-prevention strategies and reported use of those strategies; caregivers will also report on their own functioning (efficacy/confidence in parenting skills, life stress), TA youth functioning (internalizing and externalizing symptoms), parental management behaviors (expectation clarity, parental monitoring, discipline effectiveness/consistency, use of rewards), and parent-youth relationship quality (communication, conflict, support). App satisfaction and use of technology outcomes (i.e., degree of app usage, features used) will be examined and reported descriptively.
NCT05444205
The Early Childhood Collaborative of The Pittsburgh Study is a community-partnered, county-wide implementation of programs for children and families from birth through formal school entry to address real-world challenges that exist in providing effective preventive interventions for families with young children, particularly low-income families.
NCT04440228
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.
NCT02459327
This study tests a comprehensive approach to the promotion of school readiness in low-income families, beginning shortly after the birth of the child, through enhancement of positive parenting practices (and when present, reduction of psychosocial stressors) within the pediatric primary care platform. The investigators do so by integrating two evidence-based interventions: 1) a universal primary prevention strategy (Video Interaction Project \[VIP\]); and 2) a targeted secondary/tertiary prevention strategy (Family Check-up \[FCU\]) for families with infants/toddlers identified as having additional risks. VIP provides parents with a developmental specialist who videotapes the parent and child and coaches the parent on effective parenting practices at each pediatric primary care visit. FCU is a home-based, family-centered intervention that utilizes an initial ecologically-focused assessment to promote motivation for parents to change child-rearing behaviors, with follow-up sessions on parenting and factors that compromise parenting quality. Two primary care settings serving low-income communities in New York City, NY and Pittsburgh, PA will be utilized to test this integrated intervention in hospital-based clinics, providing information about translation across venues where one of the two interventions has been previously used alone. The investigators plan to test the VIP/FCU model in a randomized trial of 400 families utilizing parent surveys, observational data on parent-child interactions, and direct assessments of children's development, at key points during intervention follow-up. Analyses will address questions of program impact for the integrated program across all families and by key subgroups. The largest single contribution made by this study is to test whether an integrated primary and secondary/tertiary prevention strategy implemented in pediatric primary care can produce impacts on early school readiness outcomes, including social-emotional, pre-academic, and self-regulation. As such, this study has the potential to provide the scientific and practice communities with information about an innovative approach to promoting school readiness skills among low-income children.
NCT03960047
Motor vehicle pedestrian injury is a critical issue for school children.1-4 Each year in the US, over 4900 pedestrians are killed and another 207,000 are injured, and about 25% of these pedestrian events involve school-age children. This research focuses on 7-8 year olds, who constitute a high-risk group for pedestrian injury. At these ages children regularly cross streets without supervision and they struggle both with selecting where to cross and determining how to cross. Research has shown, however, that children are capable of benefiting from effective behavioral training in pedestrian behavior. The proposed research addresses the issue of crossing skills deficits and will: (1) implement a randomized controlled trial (RCT) to test two alternative training programs to teach 7-8 year-olds where and how to cross streets safely; and (2) conduct an economic analysis to reveal cost:benefit indices for both. Meta-analyses of pedestrian training programs reveal that behavioral training in a traffic environment most reliably produces some degree of improvement in crossing skills. Thus, 'street-side training' is often described as the gold standard. Implementation, however, poses many practical problems related to implementation. The investigators have addressed this issue by developing a training system that uses a virtual pedestrian environment and extends past VR systems by having children fully cross the street and offering the unique capability of teaching both where and how to cross, with skills in each domain measured separately so exactly what is learned and what component crossing behaviors improved can be precisely determined for each individual child. Children (7-8 years) will be randomized to one of three groups (balanced for sex): street-side training, virtual-reality training, and a no-intervention control, with the same pre- and post- measures taken across groups. Primary analyses will test for changes in indices of where and how to cross, as well as attention to traffic when crossing. An economic analysis of the two programs will reveal their relative cost effectiveness. These results will provide essential knowledge to inform future decisions about 'best practices' in child pedestrian injury prevention through behavioral training.
NCT04821856
This is a multi-site, double-blind, parallel group, randomized, placebo-controlled study of 140 participants comparing oral purified cannabidiol isolate (CBD) with placebo in reducing Severe Behavioral Problems (SBP) at 8 weeks in children aged 6 - 18 years with Intellectual Disability (ID). Eligible participants will be randomized 1:1 to receive either CBD or placebo.
NCT05539170
This randomized controlled microtrial, not just focus on parental (and child) responsiveness but also on an underlying physiological mechanism hypothesized to contribute to heightened susceptibility to parenting interventions.
NCT04763720
The objective of this study is to evaluate the implementation and use of Dyadic Developmental Psychotherapy (DDP) in three centra, with particular focus on its potential effects on the quality of the observable caregiver-child interaction. The three centra included are Telemark Hospital Trust, Department for Child- and Adolescent Psychiatric Health, Child Protective Services in Skien and Child Protective Services in Porsgrunn. The implementation of DDP is being led by Telemark Hospital Trust, while therapists from all centra are being trained in DDP as part of the implementation process. Primarily we aim to identify any changes associated with DDP treatment in the caregiver-child interaction, as measured by the Emotional Availability Scales (EA scales). Our secondary outcome measures assess changes in parental self-efficacy, parental stress, and child emotional and behavioral problems. The research aims are divided in three research questions: Q1: What changes are associated with DDP treatment: Q1.1 the quality of the caregiver-child interaction Q1.2 parental self-efficacy Q1.3 parental stress, Q1.4 child emotional and behavioral problems Based on previous literature, we hypothesize that we will see an increase in the quality of the caregiver-child interaction and parental self-efficacy after completing the DDP treatment, and a decrease in parental stress and child emotional and behavioral problems (Becker-Weidman, A. 2006) In addition to assessing the effects of DDP we will evaluate the implementation of DDP in the three centra, and inform the implementation by collecting information through interviews with patients and clinicians. We aim to answer: Q2: How do children and their caregivers experience DDP as a therapeutic intervention? Q3: How do clinicians experience the training process and the use of DDP as a therapeutic intervention? Based on previous literature, we hypothesize that we will see an increase in the quality of the caregiver-child interaction and parental self-efficacy after completing the DDP treatment, and a decrease in parental stress and child emotional and behavioral problems
NCT06587230
Purpose: The purpose of this research is to pilot test a novel, alternative, potentially sustainable system of teacher-delivered, task-shifted child mental health care. Participants: \~300 estimated Procedures: This is a RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) guided, mixed methods, clustered evaluation of Tealeaf-NC's Reach, Adoption \& Implementation (Primary Outcomes, implementation-based), as well as evaluating for preliminary indicators of Effectiveness \& Maintenance (Secondary Outcomes, clinically-based).
NCT05805410
Determine the effect of repeated pelvis perturbation training on trunk posture and locomotor function in children with CP.
NCT06311084
This study aims to investigate acceptability and feasibility of a new version of the Imaginator intervention, Imaginator 2.0, targeting self-harm behaviour in young people aged 12-25 under mental health services in the UK. Following an initial proof-of-concept study of Imaginator (Di Simplicio et al., 2020), a new version of the app that supports consolidation and practice of the techniques learnt in therapy was co-designed, and the protocol was adapted to be extended to younger adolescents. Imaginator 2.0 uses 'functional imagery training', training in individuals to develop and use functional (that is, helpful) mental images to support an alternative behaviour instead of self-harm. Mental imagery is the process of picturing something in the mind, and mental images have strong emotional and motivational characteristics. Functional Imagery Training (FIT) within Imaginator helps young people imagine adaptive behaviours as an alternative to self-harm when dealing with distressing emotions.
NCT06366620
Disruptive behavioral disorders are common in early childhood, affecting up to 15% of preschool-aged children. Behavioral parent training programs are a first-line evidence-based treatment for child disruptive behaviors. There is evidence showing that (a) these programs are effective in reducing disruptive behavior and improving long-term outcomes, and (b) there is an excellent return on investment for early intervention. Nevertheless, there is limited availability of behavioral parent training programs, particularly in rural settings, due to shortages of trained clinicians. Thus, there is a pressing need for expanding the mental healthcare workforce in rural/underserved areas. The study will involve an established parent-based behavioral intervention (First Approach Skills Training for Behavior; or FAST-B) with added pilot component incorporating parents who have previously been through parent behavioral management training programs as Peer Supports.