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Parent-Child Relations clinical trials

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NCT ID: NCT05255250 Active, not recruiting - Child Development Clinical Trials

PLAYshop: A Parent-focused Physical Literacy Intervention for Early Childhood

Start date: February 24, 2022
Phase: N/A
Study type: Interventional

The PLAYshop program is a novel, brief, theory-based, parent-focused physical literacy intervention designed to address this major public health issue of childhood physical inactivity and to support families. Primary Research Question: Does the PLAYshop program increase preschool-aged children's physical literacy, including fundamental movement skills and motivation and enjoyment, compared to controls?

NCT ID: NCT05253924 Recruiting - Preterm Birth Clinical Trials

Biological Underpinnings of Socio-emotional Regulation in Preterm Infants and Healthy Controls

Start date: July 13, 2021
Phase:
Study type: Observational

Preterm infants (PT) often need to spend their first weeks of life in the Neonatal Intensive Care Unit (NICU) where they are exposed to several adverse conditions. Whereas a consistent number of studies suggest that NICU-related experiences may have effects on infant development including long-term impairments in emotional regulation, the underlying mechanisms remain partially unexplored. Spectral analysis of EEG signal has demonstrated that frontal alpha-band asymmetry represents a reliable biomarker of social-emotional functioning. In the literature, higher right frontal activation has been associated with worse emotional regulation but no study has measured this value during a condition of social-emotional stress such as the Still Face paradigm. Our hypothesis is that higher alpha activity will be recorded in right frontal areas in premature infants compared to healthy controls and that this activation will be associated with higher negative emotionality (i.e., worse socio-emotional regulation) expressed during the Still Face paradigm. Moreover, despite several changes in epigenetic patterns have already been reported in association with prematurity and early adverse experiences, the relationship between epigenetic changes and electroencephalographic patterns (i.e. frontal alpha asymmetry) remains unexplored. The investigators therefore expect to find associations between increased methylation levels of socio-emotional and stress related genes (i.e. SLC6A4, NR3C1, OXTR, Piezo1, Piezo2, TRPV1 and TRPM8) with spontaneous oscillations of neural activity at frontal sites measured by EEG (i.e. frontal alpha asymmetry). Finally, there is ample evidence that infant's socio-emotional regulation abilities are highly dependent on the behaviors of their caregivers. More recent studies have shown that behavior can be influenced by interoceptive awareness, i.e., the ability to perceive the physiological condition of one's body in this way and to represent one's internal states. Better interoceptive awareness is associated with better recognition of others' needs, more empathetic behaviors, and better emotional regulation. Therefore, with the present exploratory study, the investigators will compare the interceptive awareness of mothers of preterm infants with that of mothers of full-term infants by exploring possible associations of this dimension with the socio-emotional responses of preterm infants and healthy controls. The investigators expect that better socio-emotional regulation of infants is predicted by a higher level of interoceptive awareness in mothers, regardless of prematurity condition.

NCT ID: NCT05233150 Recruiting - Clinical trials for Parent-Child Relations

Child-Adult Relationship Enhancement in Primary Care (PriCARE) / Criando Niños Con CARIÑO (CARIÑO)

Start date: May 18, 2022
Phase: N/A
Study type: Interventional

The purpose of this study is evaluate the effectiveness of PriCARE/CARIÑO to reduce child maltreatment, improve parent-child interactions, and reduce harsh/neglectful parenting, parent stress, and child behaviors.

NCT ID: NCT05230199 Recruiting - Clinical trials for Parent-Child Relations

Sensory Optimization of the Hospital Environment

SOOTHE
Start date: May 29, 2023
Phase: N/A
Study type: Interventional

The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.

NCT ID: NCT05214898 Enrolling by invitation - Parenting Clinical Trials

Improving Father-Child and Father-Partner Relationships Among Black and Hispanic Fathers

Start date: April 1, 2022
Phase:
Study type: Observational

Fathers play a unique role in the lives of children, with high quality interactions found to improve a child's executive functioning and general school achievement. Father involvement also has positive impacts on fathers themselves, with more involved fathers reporting more self-confidence in their parenting, more satisfaction with parenting, demonstration of more maturity, and reports of less psychosocial distress. However, poverty can have a negative association with fathers parenting and child outcomes, though paternal warmth can mediate this relationship. Children's Institute Inc will recruit and implement the 24/7 Dad program which is designed to provide a comprehensive evidenced-based fatherhood program that builds and strengthens father-child relationships. The curriculum for the primary workshops will be the 24/7 Dad curriculum, which addresses both the responsible parenting and healthy relationship areas in this project. A quasi-experimental interrupted time series (ITS) design allows for a continuous sequence of observations on a population, taken repeatedly over time.

NCT ID: NCT05206708 Recruiting - Clinical trials for Parent-Child Relations

Assesment of the Efficacy of Personalized Parent-child Psychotherapy in Children Under 3 Years Old

ECRIN
Start date: February 28, 2022
Phase: N/A
Study type: Interventional

This study aims to assess the efficacy at 4 months of a personalized strategy comparatively to a standard Psychodynamic Integrative Therapy, on childrens' symptom improvment

NCT ID: NCT05186766 Not yet recruiting - Anxiety Clinical Trials

The Effect of Video-Assisted Operating Room Introduce Program (VIASP-OR)

Start date: February 1, 2022
Phase: N/A
Study type: Interventional

Aim: The aim of this study is to evaluate the effect of the video-assisted operating room promotion program developed for parents on the anxiety level of parents and children. Design: Randomized controlled trial. Methods: The participants (N = 80) will be randomly assigned (1:1) to the intervention and control groups using block randomization. In addition to standard care, a video-assisted operating room promotion program, created by fully addressing the perioperative process, will be applied to the participants assigned to the intervention group. Participants in the control group will only receive standard care. Standard care includes verbal information about the surgical process. The sociodemographic and clinical characteristics, along with the anxiety levels of the children and their parents were measured one day before the operation, and the anxiety levels were again measured on the postoperative first and second day. Discussion: In the literature, it is seen that pediatric surgery personnel can have a beneficial effect in reducing the anxiety of children and their parents. Among these methods, the effectiveness of distraction methods on children's anxiety has also been proven. As for parental anxiety, which can be as important as child anxiety, not enough studies have been done so far, and the existing studies have not been able to come to a decisive conclusion. If parental intervention is found to have positive effects on the child's anxiety in this study are positive, it will contribute to clinical practice and improve clinical outcomes. In this respect, it will fill this gap in the literature. Impact: This research will add to the evidence for the effectiveness of an intervention that provides parents with visual and auditory information about the process prior to child surgery. It will benefit parents who want to support their children in managing this process. It will also support nurses working in pediatric surgery clinics. Trial registration: It was registered at ClinicalTrials.gov in December 2021 (…………).

NCT ID: NCT05180487 Active, not recruiting - Depression Clinical Trials

Parenting Young Children Study

Start date: January 6, 2022
Phase: N/A
Study type: Interventional

Opioid use is rising at unprecedented levels and has reached epidemic proportions in some areas of the country, particularly rural areas. Although research on the detrimental effects of opioid use on parenting and children is relatively new, it is clear that parents with opioid use struggle with a variety of parenting skills, especially contingent responsivity and warmth. As such, to have long-term sustained effects on preventing Opioid Use Disorder (OUD) in parents and to help prevent substance use and related problem behaviors in the next generation, it is critical to prevent opioid use, opioid misuse, and OUD in new parents, in tandem with providing support for parenting skills. The Family Check-Up Online (FCU Online) focuses on supporting parents by increasing parenting self-efficacy, stress management skills, self-regulation skills, and sleep routines, which are hypothesized to lead to the prevention of opioid misuse and OUD as well as improve mental health and increase responsive parenting. The FCU Online is based on the Family Check-Up, which has been tested in more than 25 years of research, across multiple settings, and is an evidence-based program for reducing high-risk behavior, enhancing parenting skills, and preventing substance use through emerging adulthood. It is named in NIDA's "Principles of Substance Use Prevention for Early Childhood" as one of only three effective selective prevention programs for substance abuse among families with young children. The FCU has also been endorsed as an evidence-based practice by the Maternal Infant and Early Childhood Home Visiting Program (MIECHV), and has been listed as a promising program by the Blueprints for Healthy Youth Development since 2013. The current project aims to address barriers of access to prevention services by delivering the FCU in a telehealth model using the FCU Online. In this research study the investigators will: 1. Work with community stakeholders in rural Oregon to expand the FCU Online to target early childhood (ages 18 months-5 years) and mothers with opioid misuse and addiction. Guided by focus group feedback, the FCU Online will be adapted to target parenting skills relevant to mothers with opioid misuse, including positive parenting, parent-child relationship building, executive functioning to help manage stress and depression, and negative parenting. A 2-month feasibility study (n=10) will test the adapted version of the FCU Online and help investigators refine intervention procedures and usability, recruitment steps, and assessment delivery. 2. Examine the efficacy of the FCU Online for rural families with opioid or other substance misuse. 400 parents with preschool children ages 18 months to 5 years and who have been identified with substance misuse, opioid misuse, or addiction will be randomly assigned to receive the FCU Online or services as usual and followed for one year. A telehealth model will be used for intervention delivery that includes targeted coaching and support. The investigators predicted that parents assigned to the FCU Online intervention will (a) show improvements in parenting skills linked to improvements in child behavior and long-term risk for subsequent substance abuse, and (b) show improvements in self-regulation and executive functioning (inhibitory control, attention shifting), which will mediate intervention effects. The investigators will also examine moderators, including neonatal abstinence syndrome/neonatal opioid withdrawal syndrome, and model intervention effects over time. 3. Examine factors related to successful uptake and implementation. To facilitate dissemination on a national scale, investigators will assess the feasibility of the FCU as an Internet-delivered intervention in rural communities with high levels of opioid use, including the extent to which participants engaged in the intervention, completed the program, and were satisfied with the program. Investigators will also assess feasibility, usage, fidelity, and uptake through engagement data collected via the online web portal. The investigators will develop materials and briefings for community agencies that will increase knowledge dissemination and, ultimately, reach a greater number of families throughout the United States who need information and services for parenting support in the context of opioid misuse.

NCT ID: NCT05135507 Withdrawn - Clinical trials for Parent-Child Relations

The Effective Parenting Program (EPP)

Start date: September 1, 2019
Phase: N/A
Study type: Interventional

The Phase I objective is to determine the feasibility of the EPP program by examining user responses to the first three units of EPP's nine interactive training modules. This feasibility evaluation will track and analyze individual program usage and examine changes in parents' psychological flexibility, parents' stress, parenting self-efficacy, parents' mindfulness and child behavior in a within subject pretest and posttest design with 50 parents of children who have DD. Qualifying parents will complete a baseline assessment and then be directed to our online learning platform to complete the interactive learning activities. This test of the Phase I prototype is intended to approximate the conditions under which the complete product will be marketed and used.

NCT ID: NCT05117099 Completed - Depression Clinical Trials

Middle School Success Over Stress

MSSOS
Start date: October 11, 2021
Phase: N/A
Study type: Interventional

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.