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Infant Behavior clinical trials

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NCT ID: NCT06030830 Recruiting - Breastfeeding Clinical Trials

SMaRT Mom - Smartphone Management and Responsive Time for Breastfeeding Mothers

SMaRT
Start date: June 6, 2023
Phase: N/A
Study type: Interventional

In the last decade, infants are born into a social environment in which the smartphone has become an essential part of our lives. Smartphone use draws the mother's attention during mother-infant interactions and thus may affect the infant development as well as maternal self-efficacy. However, the effects of smartphone use reduction among breastfeeding mothers during their interactions with their infants have not been studied yet. In the present study, we propose to evaluate a "SMaRT Mom" intervention that we have developed, to manage and reduce smartphone use during breastfeeding. The purpose of the study is to evaluate the effects of the SMaRT Mom intervention on breastfeeding mothers' biobehavioral mechanisms, self-efficacy and the socioemotional characteristics of their infants. This will extend our knowledge of the peculiarities of early mother-infant interactions in the digital era, when smartphones play a critical role.

NCT ID: NCT05474534 Recruiting - Clinical trials for Post-traumatic Stress Disorder

An Intervention to Enhance Well-Being in Trauma Exposed New Mothers

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

This pilot randomized controlled trial will evaluate the feasibility and effectiveness of a mobile neurofeedback intervention for increasing maternal overall well-being, and measuring whether mothers experience any subsequent reductions in trauma symptoms and parenting stress and enhancements in regard to emotional regulation, parenting sensitivity and positive parenting behaviors, as well as infant socio-emotional development and behavioral outcomes (i.e., crying, fussing) among postpartum mothers with symptoms of post-traumatic stress disorder. The investigators hypothesize that mothers who receive the neurofeedback intervention will demonstrate larger decreases in mental health symptoms, greater improvements in emotional regulation and observed parenting behaviors, increased feelings of parenting competency, decreased feelings of parenting stress, and reductions in the potential for child maltreatment than mothers in the control group. The investigators also hypothesize that infants of mothers who receive the neurofeedback intervention will demonstrate less crying and fussiness and higher scores on socio-emotional developmental assessments than infants of mothers in the control group at the posttest interval.

NCT ID: NCT05165589 Recruiting - Infant Behavior Clinical Trials

Validation of Active-Insights Device to Measure Crying Time

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

To assess the ability of a machine learning algorithm to accurately detect fussing and crying time in infants using accelerometery data collected from a wearable device, compared to the Barr's parent-/caregiver-completed behaviour diary.

NCT ID: NCT04068662 Recruiting - Clinical trials for Posttraumatic Stress Disorder

Intervention for IPV-exposed Pregnant Women

Start date: July 10, 2019
Phase: N/A
Study type: Interventional

The overarching goal of the proposed project is to evaluate a randomized clinical trial of the Pregnant Moms' Empowerment Program aimed at detecting its effects on maternal mental health, re-victimization, parenting sensitivity, and infant development. The project also seeks to examine theoretically-grounded mechanisms of change, including social support and empowerment. Women participating in the study will receive either the PMEP or participate in a contact-equivalent active control group during pregnancy, and will be interviewed at baseline, post-intervention and with their infants at 3 months and 1 year old. The study will occur at two sites - the University of Notre Dame and the University of Memphis. Participants will be recruited from the local community at both locations, with an equal number of women drawn from each site - Memphis, Tennessee (n=115) and South Bend, Indiana (n=115). Enrollment will continue for approximately 2.5 years, with an expected rate of 8 eligible women per month, based on a pilot study of the Pregnant Moms' Empowerment Program. The expected duration of the study for each participant will be approximately 1.5 years, with some variation due to women enrolling at different points in their pregnancy. The primary objective of the proposed project is to determine if the Pregnant Moms' Empowerment Program has positive effects on maternal mental health, re-victimization rates, parenting sensitivity, and infant development compared to women's participation in a contact-equivalent active control group. This objective will be evaluated using a multi-site randomized clinical trial design. Participants (N = 230) will be equally randomized into study arms. Eligible women will include those who are: 1) currently pregnant (primi or multiparous) and between 10 and 30 weeks gestation, 2) experienced IPV within the past year, 3) English speaking and 4) age 16 or older. The study will include 9 total visits: 4 assessments and 5 sessions for both study arms. In-person assessment visits will be completed by a trained research assistant; each visit will take approximately 2-3 hours, with post-partum assessments somewhat longer than prenatal assessments given the addition of the infant developmental assessment and parent-child observation task. Women will be compensated $30 for the first two assessments and $50 for the second two assessments. Following the final assessment, women will be invited to complete a daily diary (virtually) each day for 30 days. Each survey will take approximately 5-10 minutes to complete, and women will be compensated $2 for each completed survey. Women will also receive a $10 bonus for each set of 10 consecutive surveys. Treatment sessions will be 2 hours in duration. Women in the PMEP will complete a structured set of sessions: (1) supporting each other, support in the community, (2) identifying and understanding sources of distress, (3) cognitive and behavioral strategies to build resilience and resolve conflict, (4) perinatal health and infant care, and (5) positive parenting. Women in the active control condition will participate in facilitated discussions on a topic identified by the group. All sessions will be audio recorded so that treatment fidelity can be evaluated (for the Pregnant Moms' Empowerment Program) and so that content overlap can be assessed (for the active control condition).

NCT ID: NCT03153839 Recruiting - Infant Behavior Clinical Trials

Influence of the Aquatic Physical Activity for the Neurologic Development of the Babies

Start date: October 2016
Phase: N/A
Study type: Interventional

Introduction: physical activity in infants through aquatic therapy is widely known for the later development of sensory ,cognitive and motor areas. In this way, babies will have a greater sense of freedom, pleasure and memory of the maternal uterus. In addition, the margin therapeutic safety in the water is very broad, which allows an optimal development of aquatic early stimulation programs. Objective: To determine the relationship between aquatic physical activity in infants and the development of their psychomotor skills in their first year. Methods: A prospective case-control study will take place for 12 months. Participating infants will be divided in two groups: an experimental group, which will be integrated by 74 babies who will participate with their parents in the aquatic physical activity programme in a heated pool (34-35ºC) and a control group with 71 babies who will not participate in the activities. The aquatic activity will consist on 20 minutes sessions twice a week.