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Child Behavior clinical trials

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NCT ID: NCT06140017 Recruiting - Child Development Clinical Trials

Achieving Sustained Early Child Development Impacts at Scale: A Test in Kenya

Start date: October 24, 2023
Phase: N/A
Study type: Interventional

An estimated 43% of children under age 5 in low- and middle-income countries (LMICs) experience compromised development due to poverty, poor nutrition, and inadequate psychosocial stimulation. Numerous early childhood development (ECD) parenting interventions have been shown to be effective at improving ECD outcomes, at least in the short-term, but they are a) still too expensive to implement at scale in low-resource and rural settings, and b) their early impacts tend to fade over time in the absence of continued support. New ways to deliver effective ECD parenting interventions are sorely needed that are both low-cost to be potentially scalable, while also able to sustain impacts long-term. The rapid growth and low cost of mobile communications in LMIC settings presents a potentially promising solution to the competing problems of scalability and sustainability. Yet there is no rigorous research on mobile-health (mHealth) interventions for ECD outcomes in LMIC settings. Study investigators recently showed that an 8-month ECD parenting intervention featuring fortnightly group meetings delivered by Community Health Workers (CHWs) from Kenya's rural health care system significantly improved child cognitive, language, and socioemotional development as well as parenting practices, and a group-based delivery model was more cost-effective than previous ECD interventions. Yet it is still too expensive for scaling in a rural LMIC setting such as rural Kenya, particularly if interventions are needed that can be extended for longer periods of time to increase their ability to sustain impacts. This study will experimentally test a traditional in-person group-based delivery model for an ECD parenting intervention against an mHealth-based delivery model that partially substitutes remote delivery for in-person group meetings. The relative effectiveness and costs of this hybrid-delivery model will be assessed against a purely in-person group model, and the interventions will extend over two years to increase their ability to sustain changes in child outcomes longer-term. The evaluation design is a clustered Randomized Control Trial across 90 CHWs and their associated villages and 1200 households. The central hypothesis is that a hybrid ECD intervention will be lower cost, but remote delivery may be an inferior substitute for in-person visits, leaving open the question of the most cost-effective program.

NCT ID: NCT06138405 Not yet recruiting - Child Behavior Clinical Trials

Dental-Child Interaction Training

DCIT
Start date: October 2024
Phase: N/A
Study type: Interventional

The goal of this behavioral, interventional clinical trial is to provide a specialized workshop training for dental providers (e.g., dentists, hygienists, assistants) to improve interactions with young children (2-10 years old) and parents/caregivers. The training is derived from a well-established behavior management program for preschoolers, Parent-Child Interaction Therapy (PCIT). The main questions it aims to answer are: - Change in behavior of dental providers - Acceptability of training by dental providers All participants will receive the same behavior training; however, one group will receive the training on a delayed schedule. Researchers will compare the immediate intervention and control group to see if the training was effective in the dental providers usage of skills.

NCT ID: NCT06111651 Not yet recruiting - Health Behavior Clinical Trials

Family-Based Prevention With Black and Latinx Children

Start date: May 30, 2024
Phase: N/A
Study type: Interventional

The main objective of this project is to test whether providing parenting support, with an added emphasis on ethnic-racial socialization and healthy lifestyle behaviors, improves the social-emotional functioning and healthy lifestyle behaviors of Black and Latinx children.

NCT ID: NCT06109766 Recruiting - Parenting Clinical Trials

Delivering Evidence-Based Parenting Services to Families in Child Welfare Using Telehealth

Start date: October 12, 2023
Phase: N/A
Study type: Interventional

The goal of this randomized controlled trial is to compare Promoting First Relationships - Home Visit (PFR-HV) to Promoting First Relationships - Telehealth (PFR-T) among parents of 6-12 month olds in the child welfare system. The main questions it aims to answer are: - Is PFR-T effective relative to PFR-HV and Usual Care with respect to observed parent sensitive and responsive care, parent knowledge of child social and emotional development, and child externalizing behavior? - Is PFR-T effective relative to PFR-HV and Usual Care with respect to child out-of-home placement in foster care relative to the control group? - How does PFR-T compare in a benefit-cost analysis to the cost-effectiveness relative to PFR-HV and Usual Care? - Are eligible families impacted by the lack of technology and Wi-Fi/cellular data to engage in PFR-T? - How does provider adherence and fidelity in delivery of PFR-T compare to adherence and fidelity of PFR-HV? What will participants be asked to do? 1. Participants will be asked to agree to randomization, resulting in their placement in one of three groups: PFR-HV, PFR-T, or the control group. 2. Participants will be asked to participate in three virtual research visits, over the course of approximately 12 months (families could be finished as early as 9 months, however in our experience, intervention sessions and research visits often need to be rescheduled, delaying completion of the study). The research visits take approximately 80 minutes, and families will be paid $75 for each visit they participate in. 3. During the research visit, the families will be asked to participate in videotaped research activities involving parent-child play and interaction. Parents will be asked to answer questions regarding their background, feelings, parenting opinions, and stress. 4. Families randomized to the PFR-HV intervention are asked to participate in a 10 week in home parenting program which includes videotaped caregiver-child interactions and feedback. 5. Families randomized to the PFR-T intervention are asked to participate in a 10-week parenting program that will occur over Zoom, which will include videotaped caregiver-child interactions and feedback. 6. Families randomized to the control group will be emailed a resource packet with some information about services or programs that might be helpful for them.

NCT ID: NCT06084910 Not yet recruiting - Child Behavior Clinical Trials

Cultural Pride Reinforcement for Early School Readiness Study

CPR4ESR
Start date: August 2024
Phase: N/A
Study type: Interventional

African American children disproportionately experience racism, which is associated with behavioral health problems and school failure. Behavioral health problems impede learning and are more likely to be chronic, severe, disabling, and untreated in African Americans compared to Whites. Clinic-based interventions that boost cultural pride may improve outcomes related to behavioral health in young African American children. However, little is known about cultural pride interventions in this population. It is important to understand these processes in young children because early childhood is a period during which racial bias may develop and stymie behavioral health and learning, and cultural pride may support it. This project will recruit patients from primary care clinics in Los Angeles. The project will test a cultural pride intervention (Cultural Pride Reinforcement for Early School Readiness (CPR4ESR)) in young African American children. CPR4ESR provides culturally themed children's books and advice at health supervision visits of children enrolled at ages 2-4 years. It is based on a well-established national program called Reach Out and Read (ROR). ROR provides children's books and book-sharing advice at health supervision visits with reports of increased book-sharing behaviors and literacy. The specific aims of the proposed project are to: 1) assess the feasibility and acceptability of CPR4ESR implementation among parents and providers, 2) evaluate the capacity of CPR4ESR to improve cultural pride reinforcement and book-sharing behaviors in caregivers of young African American children, and 3) evaluate the capacity of CPR4ESR to improve behavioral health and literacy in young African American children. The interviews conducted in Aim 1 will guide refinement of the intervention tested in Aims 2 and 3. The mechanism by which CPR4ESR impacts behavioral health and literacy will be evaluated by statistical modeling. We hypothesize that: 1) caregivers who receive CPR4ESR will exhibit more CPR and book-sharing behaviors than those who do not, 2) children who receive CPR4ESR will exhibit better behavioral health and literacy than those who do not, and 3) increases in caregiver CPR and book-sharing behaviors will be associated with enhanced child behavior and literacy. This project will inform the development of interventions that address the negative health impact of racism on young African American children.

NCT ID: NCT06064578 Recruiting - Depression Clinical Trials

The Ukrainian Student Problem Solving Project

Start date: October 15, 2023
Phase: N/A
Study type: Interventional

The purpose of this study is to test the effectiveness of a universal, digital, single-session intervention for youth mental health, functioning, and well-being. The investigators will be providing access to a brief online program (Project SOLVE) for students as part of the school curriculum. Ukrainian students living in Poland will be randomly assigned to receive Project SOLVE either immediately or after 3 months. The program is designed to help students manage stress and reach their academic and personal goals by teaching them how to solve problems systematically. The investigators would like to evaluate the effectiveness of this intervention in improving students' mental health and well-being.

NCT ID: NCT06057090 Enrolling by invitation - Anesthesia, Local Clinical Trials

Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?

Start date: September 13, 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients. The main questions it aims to answer are: - Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients? - How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment? - Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room? All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.

NCT ID: NCT06052878 Completed - Clinical trials for Neurodevelopmental Disorders

Neurodevelopmental Outcome After Prenatal Anesthesia

Start date: October 9, 2023
Phase:
Study type: Observational [Patient Registry]

In 2016, the US Food and Drug Administration raised concerns about the potential negative effects of anesthesia exposure on neurodevelopment in children during pregnancy or before the age of three. The impact of exposure to anesthetic agents on neurodevelopmental outcome however remains debated: clinical studies on the subject do not allow for unequivocal conclusions to be drawn, given their methodological heterogeneity and the numerous confounding environmental factors. To this date, only two studies have focused on the potential neurodevelopmental effects of general anesthesia during the prenatal period, even though general anesthesia for non-obstetric surgery during pregnancy affects up to 3% of pregnant women. This observational ambidirectional study would be the first to investigate the potential neurodevelopmental effects of prenatal exposure to anesthesia, whether general or regional, for surgery during pregnancy. It would thus differentiate between the contribution of surgical stress and that of anesthetic agents in any observed modifications. The aim of the study is: Are there any subtle modifications of executive functions associated with prenatal exposure to anesthesia during non-obstetric surgery during pregnancy? To investigate this, parents of the participating children will be asked to complete a standardized parental telephone questionnaire from the "Behaviour Rating Inventory of Executive Function" (BRIEF). This parental questionnaire allows for evaluating children's behaviors related to executive functions. Researchers will compare the score derived from the "BRIEF" parental questionnaire (BRIEF score) between three groups of children aged from 5 to 12 years old, born between 2011 and 2018 at Caen University Hospital: - The " General anesthesia " group: children whose mothers underwent general anesthesia for non-obstetric surgery during pregnancy (N: 62). - The " Locoregional anesthesia " group: children whose mothers underwent regional anesthesia for non-obstetric surgery during pregnancy (N: 31). - The " Control " group: children whose mothers did not undergo any surgical intervention during pregnancy (N: 62). The first aim of our study is to investigate the presence of a significant difference in the BRIEF score between the three groups. The seconds aims are to assess the cognitive functioning of patients in their daily lives (school, parental home, and extracurricular activities).

NCT ID: NCT06039462 Completed - Child Behavior Clinical Trials

Virtual Reality Distraction Therapy in Paediatrics

Start date: September 23, 2021
Phase: N/A
Study type: Interventional

For many children in hospital, having blood tests or cannulation is a significantly distressing event physically, psychologically and emotionally. Use of distraction during invasive procedures is already common practice in paediatrics to improve the experience both for the child and parents. Use of Virtual Reality (VR) and VR Distraction Therapy (VRDT) is a relatively new concept, but has already shown promising results in studies. "VR offers an interactive distraction technique, a contrast to the passive distraction of reading a book or playing games on a tablet … and [VR] is thought to alter pain perception and the child's interpretation of pain signals." (Cochrane Library - Virtual reality simulation for reducing pain in children). The project aims to collect data about venepuncture, cannulation, long lines - qualitative and quantitative data - from children and parents. This studyl compares current standard practice with VR distraction therapy.

NCT ID: NCT05944315 Recruiting - Child Behavior Clinical Trials

Injury Prevention Model For K-1 Students

Start date: June 20, 2023
Phase: N/A
Study type: Interventional

There is no educational injury prevention model uniquely suited for kindergarten and first grade (K-1) students. The Teddy Bear Injury Clinic (TBIC) is a unique modification of the teddy bear clinic to facilitate classroom injury prevention teaching The TBIC will be administered to K-1 students, aged 5-7 years. Initial analysis will be descriptive and qualitative. Subsequent randomization of students to test and control groups followed by statistical analysis will be done to evaluate for effectiveness of the educational model