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Mother-Child Relations clinical trials

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NCT ID: NCT05424471 Completed - Obesity Clinical Trials

Preventing Early Childhood Obesity, Part 1: Long-term Follow-up

PECO1-LTF
Start date: May 1, 2021
Phase: N/A
Study type: Interventional

This study extends follow up on of Native American (NA) mothers and their children (now age 3-5 years) enrolled in the 1:1 randomized controlled trial of the Family Spirit Nurture (FSN) intervention designed to prevent early childhood obesity (PECO 1). The investigators will examine whether positive FSN impacts on sugar sweetened beverage (SSB) consumption and healthy growth in the first year of life were sustained. The investigators will also examine the effects of the emergency COVID-19 water solutions on water insecurity, early childhood SSB consumption, and growth, and explore how COVID-19 affected child feeding patterns and weight status either through changes in maternal mental health or household food access.

NCT ID: NCT05358457 Not yet recruiting - Psychosis Clinical Trials

Pilot Study to Evaluate the Effectiveness of Online Familiar Metacognitive Training (MCTf)

MCTf
Start date: September 2022
Phase: N/A
Study type: Interventional

The objective of this study is to adapt and evaluate the efficacy of Familiar Metacognitive Training (MCTf) in mothers and adolescent children in a group context with the main purpose of improving family relationships, cognitive awareness and symptoms of women with psychosis and the knowledge of the disease by the children. Secondary objectives: to evaluate the improvement in metacognition and social cognition, symptoms, protective factors and self-perception of stigma.

NCT ID: NCT05292924 Not yet recruiting - Clinical trials for Breastfeeding, Exclusive

Early Versus Inmediately Skin to Skin Contact in Cesarean Section

Start date: July 2022
Phase: N/A
Study type: Interventional

Breastfeeding plays a fundamental role in the health of girls and boys by providing adequate nutrition, promoting development and mainly preventing diseases. Different maternal factors such as education or obesity and perinatal factors such as the route of birth or skin-to-skin contact, among many others, can influence its onset, proper establishment and duration. Caesarean section and instrumental delivery are directly related to a delay in the early initiation of breastfeeding in newborns. In Mexico, the rate of caesarean sections is well above that recommended by the World Health Organization, in addition to being a country with very low rates of exclusive breastfeeding at 6 months of age of the newborn without having achieved the proposed objectives to improve it in recent years. Newborns who experience skin-to-skin contact with their mother develop behaviors such as crawling to the breast and more effective suckling with greater lactogenesis by the mother. The World Health Organization (WHO) defines skin-to-skin contact (SSC) as "direct, immediate and uninterrupted contact of the infant with the mother's skin" and promotes it because it is important for establishment of breastfeeding, neonatal and child survival and development. It has been seen that the ideal time to start this CPP is within the first 30 minutes of life of the newborn in any birth route, so it has been recommended that it be started in the recovery room or even in the operating room during birth by caesarean section in order to make a mark in the programming of the future physiology and behavior of the dyad. The foregoing leads us to ask ourselves the following research questions: Can we in our public hospitals in Mexico carry out the CPP procedure between mother and baby during cesarean births? And if so, will there be a difference in breastfeeding by Mexican women, performing skin-to-skin contact immediately even in the operating room between mother and baby in cesarean births versus if it is carried out after the surgical procedure?

NCT ID: NCT05241600 Recruiting - Maternal Behavior Clinical Trials

Neurobehavioral Effects of Prenatal Mindfulness Training on Maternal Presence and Compassionate Love

Start date: December 1, 2018
Phase: N/A
Study type: Interventional

This study investigates how prenatal mindfulness training fosters prosocial qualities a mother brings to parenting-specifically, her ability to be present with and experience compassionate love for her child. The mother-child relationship profoundly shapes the way humans learn to experience the world and relate to other people. It is known that mothers who respond more sensitively to their infant's emotional cues form more secure attachment relationships that, in turn, foster positive social-emotional development in the child. Thus, programs that strengthen the capacities supporting maternal sensitivity, such as mothers' ability to attend fully to their child's range of emotions with compassion and lovingkindness, hold great potential for promoting intergenerational well-being. Ideally, such capacities would be cultivated before the child is even born so as to have the greatest cumulative impact. Mindfulness-Based Childbirth and Parenting (MBCP) is a 9-week program developed to train pregnant women and their partners in the foundations of mindfulness and prepare them to apply mindfulness to birthing and parenting an infant. The intervention has shown beneficial effects on women's psychological wellbeing but has not yet been studied in relation to parenting outcomes. In addition, little is known about (a) biobehavioral mechanisms of action in MBCP, and (b) characteristics of expectant mothers that may moderate the impact of the training. It is important to address these gaps to determine the scope of prenatal mindfulness training effects and who could benefit most from such a program. This study aims to fill these gaps through an active comparison, randomized controlled trial (RCT) of MBCP compared to (non-mindfulness-based) childbirth education. The investigators will compare mothers who have completed MBCP to mothers with no mindfulness training on both behavioral (self-report) and biological (neural activation to infant cues) indices of prosocial parenting qualities toward the following aims: Aim 1: Determine the effect of prenatal mindfulness training on self-report measures of maternal presence and compassionate love. Hypothesis 1: Mothers who have taken part in MBCP will report higher levels of mindful presence, love, and compassion for their infants. These differences will be evident both immediately following the course and sustained later with their infants. Aim 2: Determine the effect of prenatal mindfulness training on neural activation to one's infant in regions supporting presence and compassionate love. Including neural measures may reveal intervention effects not yet obvious at the behavioral level that have important consequences for mother/infant functioning. Hypothesis 2: Mothers who have taken part in MBCP will show increased neural activation to their infant's emotion cues in brain regions involved in present-centered attention (anterior cingulate cortex [ACC] and dorsolateral prefrontal cortex [dlPFC]), emotional resonance (ACC, insula, ventral prefrontal cortex [vPFC]), and mammalian bonding (striatum). Aim 3: Identify moderating factors that strengthen the effects of prenatal mindfulness training. Hypothesis 3: Mothers who begin the class with more risk characteristics (single parent, history of birth complications or losses, greater distress) will show greater benefits of MBCP, as will those with higher mindfulness practice dosage. Addressing these aims will shed much-needed light on the ways that mindfulness training during a key developmental life transition can enhance prosocial qualities that contribute to the health and well-being of subsequent generations.

NCT ID: NCT05236023 Recruiting - Premature Birth Clinical Trials

Family Centred Healthcare - Zero Separation and Couplet Care

Start date: June 14, 2022
Phase: N/A
Study type: Interventional

Today mother and infant are routinely separated directly after birth if there is a need of specialised treatment and care, despite of the significant and positive effects of skin-to-skin contact. Thus, there is a need of change in organizing the treatment and care in a way that minimizes separation. The aim is to evaluate the implementation and effect of a complex family-centred intervention based 107 on zero separation and couplet care. The intervention is rooted in the philosophy of family-centred care. Essentially, mother infant dyads will be admitted together, where they will receive couplet care by neonatal nurses. The study comprises a quasi-experimental trial and a qualitative process evaluation including a field study and two interview studies. Finally, a health economic evaluation will be conducted to assess the cost-effectiveness of this complex intervention. The intervention will take place at the Neonatal Intensive Care Unit at Hvidovre Hospital. The nurses will as a part of the intervention be educated to take care of both mother and infant and carry out the intervention. Five families with experiences from the Neonatal Intensive Care Unit and the Maternity Unit participates as patient and public representative in the project, as their experiences and ideas will provide an added value to the project. This study contribute with a new perspective on how to organize the treatment and care of a newborn family in a Neonatal Intensive Care Unit. The study will be the first to examine zero separation and couplet care within sick mother-infant dyads. The study will provide knowledge about how an intervention consisting of zero separation and couplet care can be feasible and acceptable, and what kind of effect and impact it will provide. It is expected that the study as a whole may impact and profile clinical nursing, as well as benefitting public health.

NCT ID: NCT05214859 Recruiting - Clinical trials for Intellectual Disability

Enhancing Mother-Child Ties and Psychosocial Wellness Through Arts Among Children With Intellectual Disability and Their Mothers

Start date: July 9, 2022
Phase: N/A
Study type: Interventional

The caregiving of children with intellectual disability (ID) is intensive and challenging. Caregivers, particularly mothers, are left in a vulnerable and stressful condition. Children with ID may experience difficulties in expressing emotions and may have behavioral or emotional problems. These difficulties impose extra challenges for the parents to understand and interact with their children with ID. Existing intervention programs for families having children with ID primarily focus on problem-and-emotion-focused measures. While strategies focusing on improving parent-child relationships, mother-child communication, and wellness of the dyads are limited. Expressive arts-based intervention (EXAT) adopts multiple art modalities for achieving therapeutic goals. It can bypass verbal expression and complicated cognitive processing during interactions, and it is also safe, engaging, enjoyable, and empowering. While existing evidence supports the use of arts-based intervention on children and their parents, there is a limited understanding of the application of dyadic EXAT on the mother-child relationship and their wellness. The main objective of this study is to evaluate the effectiveness of the dyadic Expressive Arts-based Intervention (EXAT) on the psychosocial well-being of mother-child dyads. Primary outcomes include parent-child relationship, parenting stress, and caregiver burnout; secondary outcomes include mother's affect and quality of life; child's mood, emotional expression, behavioral and emotional problems. This study adopts a mixed-methods design with quantitative, qualitative, and art-based assessment methods. This study is a randomized controlled trial, running for 3 years for evaluating the effectiveness of the dyadic Expressive Arts-based Intervention (EXAT). 154 Chinese mother-child dyads will be randomized into (i) a dyadic EXAT group or (ii) a treatment-as-usual waitlist control group. Quantitative analysis will be adopted to investigate the effectiveness of the dyadic intervention on the psychosocial outcomes of children with ID and their caregiving mothers. The qualitative component will consist of longitudinal in-depth interviews with mothers to understand the experiences, perceived changes, and factors that facilitate the process. Art-based assessment will also be used to understand the changes in the emotional expression of children with ID. Data collected will be triangulated to provide an integrative evaluation of the effectiveness of the intervention.

NCT ID: NCT03975530 Completed - Child Development Clinical Trials

Piloting a Precision Approach to Home Visiting

Start date: June 24, 2019
Phase: N/A
Study type: Interventional

The proposed study will be a randomized pilot study. Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either standard Family Spirit or precision Family Spirit to their clients. Sites in both groups will use an electronic platform to support implementation. The investigators will select four sites and randomize two of them to standard Family Spirit and two to precision Family Spirit. Sites will be matched based on annual volume of clients served and geographic similarity (i.e. urban vs. rural). All participating sites will be trained in the electronic implementation support platform. The two sites randomized to provide the precision approach will receive additional training on how to provide it. In each site, all new clients who are prenatal or up to 2-months postpartum will be offered participation in the study. The study will then follow them until 12 months postpartum and measure outcomes during this time (see measurement table below). Qualitative interviews with precision participants will be done at 6 and 12 months postpartum. Focus group discussions with home visitors will also be completed during regular study team meetings. Analysis of study instruments (basic psychometrics based on baseline and end line data) and preliminary differences between the sites on Aim 3 and 4 outcomes will be done in December 2019 assuming the investigators have achieved their estimated sample size with enough retention for 6-months post enrollment. Dissemination of results will be done upon completion of the analysis.

NCT ID: NCT03334266 Completed - Obesity Clinical Trials

Preventing Early Childhood Obesity, Part 2: Family Spirit Nurture, Prenatal - 18 Months

Start date: September 25, 2017
Phase: N/A
Study type: Interventional

This study aims to assess the impact of a home-visiting program, called "Family Spirit Nurture" (FSN), on reducing early childhood obesity in American Indian (AI) children. The FSN intervention targets parent feeding practices, young children's diet and physical activity (PA) and early childhood (0-2 years of age) weight status, all associated with risk for early childhood obesity and, consequently, risk for obesity over the life course. The investigators will also explore whether maternal psychosocial factors (stress, depression and substance use), household food/water security and/or constrained physical activity environments moderate FSN intervention impacts on: mother's feeding behaviors for infants and toddlers; and, children's diets, PA patterns, and weight status. Finally, the investigators will examine how maternal/infant characteristics, diet and behaviors impact the underlying biologic mechanisms of early childhood obesity and whether social and behavioral interventions can impact infant metabolic health. The investigators evaluation will employ a randomized controlled design, in which both the intervention and comparison condition receive assisted transportation to prenatal and well-baby visits (called "Optimized Standard Care"), and the comparison condition also receives potentially beneficial injury prevention education at 8 assessment visits. Primary Aims: Efficacy of Family Spirit Nurture (FSN) + Optimized Standard Care (OSC) versus Injury Prevention Education (IPE) + OSC will be assessed for each of the following from birth to 24 months postpartum: Aim 1. Mothers' implementation of recommended feeding behaviors. Hypothesis 1. FSN + OSC mothers will be more likely to meet breastfeeding and complementary feeding recommendations and engage in responsive parenting/feeding behaviors compared to IPE + OSC mothers. Aim 2. Children's consumption of healthy diet and physical activity engagement. Hypothesis 2. FSN + OSC children will consume more fruits and vegetables and fewer calories from sugar sweetened beverages (SSB), snacks and desserts, and they will have higher physical activity and reduced screen time/other sedentary activities compared to IPE + OSC children. Aim 3. Children's weight status. Hypothesis 3. Mean BMI z-scores for FSN + OSC children will be closer to zero (the mean age- and sex- specific BMI z-score for the World Health Organization standard reference population) compared to IPE + OSC children.

NCT ID: NCT03300713 Recruiting - Clinical trials for Depression, Postpartum

MOther-Child Interaction Assessment TRAINING for Pediatricians

MOCITRAINING
Start date: December 2, 2017
Phase: N/A
Study type: Interventional

The originality of the MOCITRAINING study lies in the integration of infant and maternal care during the pediatric consultation and the assessment of the impact of this type of care in the short and medium term on The MOCITRAINING program could contribute to improving the quality of parent-child interactions.

NCT ID: NCT03271723 Completed - Physical Activity Clinical Trials

The 2015 Pelotas (Brazil) Birth Cohort Study

Start date: April 15, 2014
Phase: N/A
Study type: Observational

This is the fourth birth cohort to be carried out in the city of Pelotas (Brazil) including more than 4 thousand children followed-up since the pre-natal period to study maternal-child health.