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Maternal Distress clinical trials

View clinical trials related to Maternal Distress.

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NCT ID: NCT06054412 Recruiting - Clinical trials for Post Traumatic Stress Disorder

An Adjunctive Neurofeedback Training Program to Enhance Wellness Among Trauma-Exposed Postpartum Mothers

Start date: March 3, 2024
Phase: N/A
Study type: Interventional

The proposed study will collect novel data evaluating the feasibility of the NFB training program delivered in an outpatient mental health setting and its influence on mothers' overall sense of well-being, and further investigate whether enhanced well-being is associated with positive changes in emotion regulation capacities, trauma-related mental health symptoms, parenting behaviors and attitudes, and infant behavioral outcomes (i.e., crying, fussing) among postpartum mothers with a history of childhood trauma and clinically concerning trauma-related mental health symptoms.

NCT ID: NCT05694676 Completed - Cerebral Palsy Clinical Trials

Relationship Between Prenatal Maternal Distress and the Quality of General Movements at 3 Months

Start date: February 17, 2023
Phase:
Study type: Observational

Depression and anxiety symptoms are common during pregnancy which may disturb the intrauterine environment by affecting the mother's physiological responses to stress, and ultimately impair fetal and postnatal development. There is increasing evidence about the effects of maternal distress on young brain tissue leading to some structural changes. The neurological footprints of these structural changes on the young brain may be caught early in life by a video assessment of General Movements (GMs) quality.

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: NCT05419167 Active, not recruiting - Mental Health Issue Clinical Trials

STEP-COVID: A Program for Pregnant Women During the SARS-CoV-2 Pandemic

Start date: September 1, 2020
Phase: Phase 1
Study type: Interventional

STEP-COVID (Supporting the Transition to and Engagement in Parenthood during the COVID-19 pandemic) is a manualized group intervention for pregnant women during the COVID-19 pandemic designed to foster emotion regulation and reflective capacities in participants.

NCT ID: NCT05343403 Active, not recruiting - Premature Birth Clinical Trials

Parental Participation on the Neonatal Ward - the neoPARTNER Study

neoPARTNER
Start date: March 7, 2022
Phase:
Study type: Observational

Objective: To investigate the effect of FCR as part of the FICare principles during hospital stay, on parental stress at discharge in parents of preterm or ill infants admitted to the neonatal ward for >7 days as compared to standard medical rounds (SMR) without parents as part of standard neonatal care (SNC).

NCT ID: NCT05262920 Completed - Pain, Acute Clinical Trials

Promoting Self-Management of Breast and Nipple Pain With Technology (PROMPT) for Breastfeeding Women Study

PROMPT
Start date: March 16, 2022
Phase: N/A
Study type: Interventional

Every year, 1 million women cease breastfeeding (BF) before 6 months, the minimum time required for optimal maternal well-being and infant's health, physical growth, and development. The highest rate of BF cessation occurs within 3 weeks after birth, with 30% of women ceasing BF due to acute breast and nipple pain (BNP). BNP is a complex and understudied biobehavioral phenomenon involving nociceptive signalling that stimulates multiple pain pathways. Women who experience BNP beyond BF initiation report lower BF self-efficacy a key predictor of BF at 6 months, increased maternal distress symptoms, and may differ across races contributing to differences in early BF cessation rates. The investigators developed and tested a 6-week nurse-led and participant-informed, Breastfeeding and Breast and Nipple Pain Self-Management (BSM) intervention guided by the Individual and Family Self-Management Theory. Aligned with the needs and preferences elicited from a diverse sample of BF participants, the investigators used a cloud-based platform, to deliver BF knowledge and skills, and provided support through nurse-led text-based communication to decrease BNP, increase BF self-efficacy, decrease burdensome face-to-face visits, and increase adaptive coping behaviors. Participants in the BSM intervention group reported significantly reduced BNP intensity at 1 and 2 weeks which predicted increased BF self-efficacy and decreased anxiety at 6 weeks. Based on these promising results, the investigators propose to examine the efficacy of the BSM intervention in an R56 RCT, Promoting Self-Management of Breast and Nipple Pain Using Technology (PROMPT) for Breastfeeding Women to decrease BNP intensity and interference and increase BF exclusivity. The study will reproduce and extend the pilot findings by exploring in a diverse population of BF participants, how participants' pain sensitivity affects BNP. The study will explore the moderating role of BNP, and maternal well-being symptoms of fatigue, depressive symptoms, anxiety, and sleep, pain, pain coping, and maternal self-efficacy, on BF exclusivity. Participants (N = 222) intending to breastfeed will be randomized to the BSM intervention or the attention control group with assessments performed at baseline, 1, 2, 3, 6, 9, 12, 18, and 24 weeks. Study results will advance knowledge on the BSM intervention, with direct implications for nurse-designed and led self-management interventions in clinical settings or health care systems.

NCT ID: NCT04829864 Active, not recruiting - Mental Health Issue Clinical Trials

Supporting the Transition to and Engagement in Parenthood

STEP
Start date: June 15, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

STEP (Supporting the Transition to and Engagement in Parenthood) is a manualized group intervention for pregnant women exposed to early life adversity designed to foster emotion regulation and reflective capacities in participants.

NCT ID: NCT04803344 Completed - Clinical trials for Health Care Utilization

The Effectiveness of Expressive Writing on a Sample of New Mothers

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

This pilot study aims to evaluate the effects of an expressive writing intervention on a sample of new mothers after the childbirth on the psychological health and on the healthcare costs. The mothers were evaluated also in a follow-up one month after the end of the expressive writing intervention.

NCT ID: NCT04749888 Active, not recruiting - Pregnancy Related Clinical Trials

Impact of the Korea Early Childhood Home-visiting Intervention

KECHI
Start date: October 27, 2021
Phase: N/A
Study type: Interventional

Maternal and early childhood home visits have been proposed as an effective strategy to improve the health and development of disadvantaged children. In South Korea (hereafter, Korea), a maternal and early childhood home visit program has been implemented since 2013 in Seoul, and then was adopted in 2019 by the central government as a national policy for child health and development. The Korea Early Childhood Home-visiting Intervention (KECHI) encompasses 25-29 home visits, group activities, and community service linkage by social workers from the prenatal period until the child reaches the age of 2 years; as such, it is a complex intervention involving various domains to address a wide range of outcomes. Each home visit is implemented based on the family's needs, and individualized interventions are provided to improve parenting and the home environment in order to promote children's health and development and maternal health. This study is a randomized controlled community trial conducted in Korea to examine the impact of targeted home visits led by nurses in the prenatal and early childhood period on children's health and development and maternal health. This study is a superiority trial with two parallel groups from pregnancy until the child reaches 2 years of age. Pregnant women with two or more risk factors will be recruited to participate in the study after they provide informed consent. Participants will then be randomly assigned to the intervention or control group with a 1:1 allocation through an independent web-based random allocation system. We expect a total of 800 families (400 families in each group) to be recruited. The intervention group will receive the KECHI program and the control group will receive existing maternal and child health services (usual care), but not multiple home visits by nurses. Both groups will receive gift cards of 30,000 Korean won (about 27 USD) for each round of surveys. The intervention and control groups will be surveyed on the outcome variables of home environment, child development, breastfeeding, maternal health, child hospital visits due to injuries, and community service linkage at four home visits by trained research nurses at baseline and at 6 months, 12 months, and 24 months after birth. Telephone contact will also be made at 6 weeks and 18 months after birth for both groups. Outcome measurements will be performed by research nurses and data management will be conducted by statistical analysts. The analysis will be conducted for the intention-to-treat (ITT) and per-protocol (PP) groups, with an interim analysis of outcomes up to the 6-month follow-up. For the primary outcomes and certain secondary outcomes, subgroup analyses will be performed based on factors such as region, fertility status, number of risk factors, presence of depression, education level, etc.

NCT ID: NCT04730570 Completed - Maternal Distress Clinical Trials

Essential Coaching for Every Mother, a Postpartum Text Message Program for Canadian Mothers

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

The purpose of this study is to evaluate a text message-based program called Essential Coaching for Every Mother which sends daily text messages during the immediate six-week postnatal period. Essential Coaching for Every Mother consists of standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health.