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Maternal Behavior clinical trials

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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: NCT05015023 Recruiting - Maternal Behavior Clinical Trials

Effectiveness of Health Education Provided to Couples on Utilization of Maternity Waiting Homes in Rural Ethiopia

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

Maternity waiting homes (MWHs) were identified as a solution to improve pregnancy outcomes by bringing women living in geographically isolated areas closer to a healthcare facility. Literature shows that MWHs contribute significantly to the reduction of maternal death and stillbirth among users. Despite its importance in improving maternal & neonatal health outcomes, the utilization of MWHs is very low in Ethiopia. It is important to investigate what strategies could be effective in improving MWH utilization. Therefore, in this study cluster-randomized controlled trials will be conducted to evaluate the effect of male partner involvement intervention on MWH utilization in Ethiopia.

NCT ID: NCT04847076 Recruiting - Clinical trials for Depression, Postpartum

Feasibility of M-health Version of "What Were We Thinking" Intervention to Promote Maternal Postpartum Mental Health

Start date: May 3, 2021
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the feasibility, acceptability and preliminary effectiveness of "What Were We Thinking" (WWWT) a psychoeducational intervention -delivered remotely via communication technologies- to prevent symptoms of postpartum depression and anxiety in new mothers; which has been shown to be effective in primary health settings. WWWT was developed in Australia and has been culturally adapted to be used in Chile. The m-health version of the Chilean adaptation of WWWT for the current study includes: Psychoeducational modules on issues relevant to mothers during the post-partum period; contact with the program facilitator through instant messaging services available on mobile phones and a virtual group meeting. This pilot study will use a mixed design. The quantitative component will consist of a before-after design with control group including 90 adult mothers of child aged 6-8 weeks who receive health care in a primary health centers in Santiago, Chile. Mothers will be randomized into the experimental (EG) or control groups (CG) in a rate of 1:1. Both EG and CG will receive usual treatment provided by primary health centers (TAU), and only de EG will receive the m-health adapted version of the WWWT. The qualitative component considers 12 users semi-structured interviews. The maximum variation sampling strategy will be used according to the completion of m-health version of WWWT. An open coding of Grounded Theory will be used to data analysis. The feasibility of m-health version of WWWT intervention will be evaluated in terms of eligibility rates, recruitment rates and reasons for study refusals, feasibility to deliver the three components of the intervention, data attrition and follow-up rates by treatment condition. Their acceptability considers participant completion of the intervention rates, and a qualitative assessment of the users' acceptability of and satisfaction. Secondary outcomes will include changes on maternal levels of depressive and anxiety symptoms, maternal self-efficacy and perceived social support. And differences in mother-infant quality of interaction between intervention and control groups.

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: NCT04541121 Recruiting - Maternal Behavior Clinical Trials

3D Maternal Fetal Attachment and Smoking

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

To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal attachment and aid in smoking cessation. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby

NCT ID: NCT04540458 Completed - Maternal Behavior Clinical Trials

3D Maternal Fetal Bonding

Start date: February 4, 2020
Phase: N/A
Study type: Interventional

To determine whether 3D models of fetus' face created from 3D ultrasound will increase maternal and paternal attachment, lower stress, anxiety and depression and have improved life-style choices during pregnancy. Half of participants will receive 3D model and half will receive a picture of 3D ultrasound of their baby.

NCT ID: NCT04252807 Completed - Infant Development Clinical Trials

A Common Elements-based Intervention to Improve Maternal Psychological Well-being and Mother-infant Interaction

Start date: February 7, 2020
Phase: N/A
Study type: Interventional

Background: Millions of children in low resource settings are at high risk of poor development due to factors such as undernutrition, inadequate stimulation and maternal depression. Evidence based interventions to address these risk factors exist, but often as a separate and overlapping packages delivered through disjointed systems, therefore posing problems in scale-up. A common elements approach based intervention that combines evidence-based elements from packages of care addressing early stimulation, responsive feeding and maternal distress have been developed. Objectives: The current study aims to develop an online training curriculum to train lay health workers in common elements based intervention to improve maternal psychological well-being and improve mother-infant interaction among distressed mothers in low resource rural community settings of Pakistan. The impact of intervention on maternal well-being, infant growth, nutrition and development will be evaluated at 12-months post-partum. Method: A two arm, single blind, individual randomized controlled trial (RCT) will be carried out in the community settings of the rural sub-district of Gujar Khan in Rawalpindi, Pakistan. 250 Pregnant women in third trimester of pregnancy, screened positive for psychological distress on Self-Reporting Questionnaire (SRQ), cut-off score ≥ 9, will be randomized on 1:1 allocation ratio into intervention (n=125) and Treatment as Usual (TAU) arms (n=125). The participants in the intervention arm will receive 15 monthly sessions of intervention by community volunteers at home. First three sessions will be delivered in the third trimester of pregnancy followed by one monthly session for 12 months. The primary outcome will be caregiver-infant interaction at 12-months post-partum. The maternal secondary outcomes include maternal psychological wellbeing, quality of life, social support and empowerment. Maternal outcomes will be measured at baseline, 6-months and 12-months post-partum. Infant secondary outcomes include growth, nutrition and development and will be measured at 12 months. A mixed-methods process monitoring and evaluation will be conducted to inform the feasibility of intervention delivery. Discussion: The outcomes of the study will be a common-elements based online training curriculum for training of community volunteers in intervention to improve maternal psychological well-being and mother-infant interaction in low resource rural community settings at-scale.

NCT ID: NCT03863600 Completed - Maternal Behavior Clinical Trials

Midwife-led Continuity and Satisfaction With Care - an Observational Case-Control Study in Palestine

Start date: May 1, 2017
Phase:
Study type: Observational

This study investigate if a midwife-led continuity model of care in Palestine, had impact on rural women's satisfaction with care through the continuum of antenatal, intrapartum and postnatal period.

NCT ID: NCT03748576 Completed - Diet Habit Clinical Trials

A Prospective Randomized Controlled Trial of Mobile Medical Used for Management of Pregnant Women

Start date: November 1, 2017
Phase: N/A
Study type: Interventional

A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was: 1. more effective in improving pregnancy outcomes in normal pregnant women. 2. more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.

NCT ID: NCT03688386 Active, not recruiting - Clinical trials for Language Development

A Language Intervention Study of Preterm Infants

Start date: December 4, 2018
Phase: N/A
Study type: Interventional

This is a randomized controlled trial to study a reading intervention in the NICU among preterm infants using LENA (Language Environment Analysis) recordings, linguistic feedback, and a language curriculum to improve the neonatal inpatient language environment and language outcomes for preterm infants.