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Parent-Child Relations clinical trials

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NCT ID: NCT05264415 Active, not recruiting - Depression Clinical Trials

Intergenerational Transmission of Traumatic Stress

Start date: October 6, 2021
Phase: N/A
Study type: Interventional

Millions of U.S. parents have experienced trauma, putting them at risk for maladaptive parenting practices, which then confer vulnerabilities to their children. This study aims to enhance understanding of how parental emotional dysregulation associated with traumatic stress impedes effective parenting. The study employs neurophysiological methods (electroencephalogram; EEG) to address some of the challenges inherent in the study of emotion (particularly in trauma-exposed individuals) and to identify potential biomarkers of traumatic stress and response to intervention.

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: 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: NCT05037773 Active, not recruiting - Child Development Clinical Trials

Intervention Targeting Parental Reminiscing and Its Effects on Preschoolers' Memory and Metacognition

Start date: January 21, 2021
Phase: N/A
Study type: Interventional

This randomized controlled study aims to investigate the effects of an intervention targeting parental reminiscing style on preschoolers' memory (i.e., episodic and autobiographical) and metacognition (i.e., confidence judgment and memorability-based heuristic).

NCT ID: NCT04818112 Active, not recruiting - Clinical trials for Parent-Child Relations

A Randomized Controlled Trial to Improve Mother-Infant Synchrony Among Women With Childhood Adversity

Start date: July 12, 2021
Phase: N/A
Study type: Interventional

Childhood adversity affects almost two-thirds of the US population, is a major risk factor for the leading causes of disease and increases US economic health burdens. Childhood adversity also alters biologic systems, such as the oxytocin hormone, that can affect attachment behavior. This innovative study has the potential to advance science and improve mother-infant interaction by testing an early life, home-based, multisensory behavioral intervention (called ATVV), targeting the oxytocin system, to promote synchronous early mother-infant interaction, especially critical for mothers who have experienced childhood adversity. This two-group randomized clinical trial will test the ATVV's effect on oxytocin system function and quality of mother-infant interaction. The investigators will enroll 250 first-time healthy mothers carrying a single baby who have a history of childhood adversity, and obtain baseline data in their third trimester of pregnancy. Soon after birth (before hospital discharge), mothers (and babies) who continue to be eligible are randomized into the intervention group and taught to give ATVV daily for 3 months, or randomized into the Attention Control education group and taught safe infant care. After birth, the investigators check-in frequently with mothers through weekly phone calls. There are 3 study visits at 1, 2 and 3 months after birth that include survey questions and collection of maternal blood and infant saliva. Mothers and babies are also video-recorded at 3 months after birth for 4 minutes to assess mother-infant interaction. The investigators follow-up with a phone call at 6 months after birth. While both groups will benefit from the content and attention the investigators give mothers, the investigators hypothesize that, compared to the education group, mothers and infants in the intervention group will have improved oxytocin system function and more synchronous mother-infant interaction.

NCT ID: NCT04601779 Active, not recruiting - Parenting Clinical Trials

INFANT HEALTH- Promoting Mental Health and Healthy Weight in Infancy Through Sensitive Parenting

Start date: August 16, 2021
Phase: N/A
Study type: Interventional

Mental health problems and overweight often co-occur, they have their origin in early childhood and new research evidence suggest a key role of cognitive, emotional and behavioral regulation in the early developmental trajectories and points to the benefits of intervention in infancy that builds on strategies of sensitive parenting. The research group behind this project has developed the PUF program (PUF: In Danish: 'Psykisk Udvikling og Funktion') to target infants' mental health and development within the settings of community health nurses. Still, measures are lacking that address the infants most vulnerable regarding the development and progression of mental health problems and overweight. In this project, we develop and test a new intensified intervention to address major cognitive and regulatory vulnerabilities identified at child age 9-10 months and adapted to the settings of community health nurses. The intervention is created as an add-on to the PUF-program, using an evidence-based method to promote sensitive parenting, the Video-based Intervention to Promote Positive Parenting (VIPP). The new intervention VIPP-PUF comprises six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The intervention builds on teaching the health nurses to promote parents' sensitivity to meet the infants' cognitive and regulatory vulnerabilities, and it takes in account the needs of psycho-socially disadvantaged families. The Infant Health project is conducted in sixteen municipalities across Denmark. We use the Intervention Mapping approach as the study frame and integrate the best practice of community health nurses. The efficacy of the VIPP-PUF intervention is examined in a randomized controlled step-wedge design, in which approximately 1.000 children are followed up to the age of 24 months. The VIPP-PUF intervention is hypothesized to reduce mental health problems at ages 24 months among infants with high levels of cognitive and regulatory problems at age 9-10 months, (primary outcome). Also, it is hypothesized that among children with high levels of cognitive and regulatory vulnerabilities at age 9-10 months, adding the VIPP-PUF intervention to treatment as usual at age 9-10 months, will reduce infants' cognitive and regulatory problems; promote healthy weight development; reduce parents' experiences of stress; promote sensitive parenting and promote parents' feeling of competence and relatedness.

NCT ID: NCT04440657 Active, not recruiting - Parenting Clinical Trials

Self-assured Parents - a Parenting Support Program for Immigrant Parents With Teenage Children Living in Deprived Areas

SAP
Start date: March 17, 2021
Phase: N/A
Study type: Interventional

Parents have the primary responsibility for child socialization and development, but not all parents have the same possibilities to promote their children's positive development. Immigrant parents living in deprived areas often worry about their children's safety and future, at the same time as they have difficulties facilitating the best development potential for their children. Social services can help parents and their children to attain more promising developmental outcomes through focus on early preventive parenting support efforts, but these efforts need to be culturally tailored for the best possible results. For this reason, social services in the municipality of Örebro developed a culturally sensitive parenting support program aimed at immigrant parents living in deprived areas, who are worried that their children (age 12-18) engage in or will be exposed to harmful environments. The Self-Assured Parenting Program (SAP) offers support to these parents by building on protective factors and strengthening parents in their parenting through focus on parenting competence and parent-child communication. The purpose of SAP is to increase parents' self-confidence and communication between parents and their teenagers as well as to reduce parents' worries through activities that have a clear focus on empowerment and knowledge of child development. This multi-design project aims to test the implementation and effect of TF in Örebro and other Swedish municipalities with similar problems through observation, interviews with parents and groupleaders/managers as well as longitudinal effect measurements of parenting competence, parent-child communication and worries about their children's psychosocial development. This project will allow a partnership between social workers and researchers to be formed in order to generate practice-based evidence about implementation of support to deprived parents, which can be used in the context of everyday social service practice.

NCT ID: NCT04421235 Active, not recruiting - Quality of Life Clinical Trials

Expanding Knowledge About and Evaluating Services for Incarcerated Pregnant and Postpartum Women in Arkansas

Start date: November 19, 2021
Phase: N/A
Study type: Interventional

The number of women who are incarcerated in the U.S. has increased dramatically over the past 20 years-over 750%, or from 13,258 in 1980 to 111,616 in 2016. Arkansas incarcerates 92 women per 100,000 population compared to 57 per 100,000 average across all states, ranking the state as the 8th highest in the nation. Over 75% of incarcerated women are of childbearing age and about 4% are pregnant upon intake. However, little is known about the population of women who have become incarcerated while pregnant in Arkansas - including the outcomes of these women and their children and how these outcomes may vary in relation to services that are received during incarceration. This research study aims to first expand knowledge on incarcerated women in Arkansas by using administrative data to retrospectively examine the health status and outcomes of pregnant women who were incarcerated in state prison by Arkansas from June 1, 2014 to May 31, 2019 (a five-year cohort; Aim 1). Then, we will lay the groundwork for and subsequently analyze data on outcomes and perspectives of women who have been incarcerated in Arkansas while pregnant (Aims 2 and 3). We will also seek to understand the feasibility and acceptability of elements of an enhanced support program for incarcerated pregnant women recently launched via a collaboration between Arkansas Department of Corrections and UAMS.

NCT ID: NCT04257383 Active, not recruiting - Child Development Clinical Trials

The Sugira Muryango PLAY Collaborative

Start date: May 5, 2021
Phase: N/A
Study type: Interventional

The Research Program on Children and Adversity (RPCA) has successfully grown its evidence-based home-visiting program-Sugira Muryango (SM)-in Rwanda, as policies and programs aligned with the Rwandan social protection system have evolved. The current study submission seeks to test an evidence-based implementation strategy, the PLAY Collaborative, to engage local stakeholders and frontline providers and supervisors to ensure quality improvement and sustainability of Sugira Muryango and to repeat our previous intervention to include Ubudehe 1 families with children 0-36 months in Nyanza, Ngoma, and Rubavu Districts in Rwanda.

NCT ID: NCT04129359 Active, not recruiting - Child Development Clinical Trials

FamilieTrivsel i Almen Praksis: a Mentalisation Programme for Families With Young Children

Start date: October 15, 2019
Phase: N/A
Study type: Interventional

This cluster randomised trial aims to establish the effectiveness of an online intervention designed to improve the ability of parents to 'mentalise' - in other words to understand their own mental states and that of others including their partners and young children. Effects on maternal mental state, the quality of parent-child interaction and child language, social and emotional development will be assessed.