Clinical trials: Infant Mental Health, open to volunteers
Stress Disorders, Post-Traumatic, Psychological Trauma
Postnatal Debriefing After Adverse Obstetric Events
Adverse or unexpected obstetric events can negatively affect women's psychological well-being and childbirth experience, increasing the risk of postpartum traumatic stress.
- Conditions
- Stress Disorders, Post-Traumatic, Psychological Trauma, Obstetric Labor Complications, Postpartum Period
- Trial name
- DBIRTH (NCT07579273)
- Testing
- Structured Postnatal Debriefing, Usual Care
- Volunteers
- 142 people
- Sponsor
- Parc de Salut Mar
Postpartum Depression, Postpartum Anxiety
Mother-infant Bonding in the Brain: a Mindfulness-based Intervention
The study investigates the effectiveness of the mindfulness-based intervention "Mindful with your Baby" in women with babies between 5-9 months postpartum who experience heightened levels of postpartum depression, anxiety and/or…
- Conditions
- Postpartum Depression, Postpartum Anxiety, Parental Stress
- Trial name
- NCT05830266
- Testing
- "Mindful with your Baby" group-based therapist-guided intervention, "Mindful with your baby" self-guided online intervention
- Where
- Netherlands
- Volunteers
- 64 people
- Sponsor
- Tilburg University
Cerebral Palsy Infantile, Pre-Term
Motor-voice Assessment in Infants (MAMI)
The goal of this observational study is to discover features of normal and disordered motor-voice profiles that are biobehavioral markers of physical disability in infants..
- Conditions
- Cerebral Palsy Infantile, Pre-Term, Motor Delay, Neurodevelopmental Disorders
- Trial name
- MAMI (NCT06807203)
- Testing
- Behavioral observation
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- Ohio State University
Child Development
Effectiveness of a Baby App for Enhancing Infant Mental Well-being (RCT)
This RCT aims to design and develop a developmental guidance program delivered by a smartphone app "Happy Baby HK" and evaluate its effectiveness for enhancing the mental well-being of recently born infants in Hong Kong.
- Trial name
- NCT06163560
- Testing
- Smartphone app "Happy Baby HK", Family Health Service parenting booklet
- Where
- Hong Kong
- Volunteers
- 586 people, healthy volunteers welcome
- Sponsor
- The University of Hong Kong
Cystic Fibrosis (CF)
TIDES 2.0: Prevalence and Longitudinal Course of Depression, Anxiety, and Behavior Problems in Children With Cystic Fibrosis Under 12 Years of Age
This is a longitudinal, observational epidemiological study designed to estimate the prevalence of depression, anxiety, and behavior problems in children ages 18 months through 11 years with cystic fibrosis (CF).
- Trial name
- TIDES 2 (NCT07048574)
- Where
- 13 sites in United States
- Volunteers
- 600 people
- Sponsor
- State University of New York at Buffalo
Maternal Stress
Impact of Vitamin D Supplements on Mental Health and Milk Composition in Mothers Living in Idaho
Mothers of preterm infants experience exaggerated emotional stressors compared to those typically associated with new motherhood, making these women particularly vulnerable to postpartum depression.
- Trial name
- NCT06919718
- Testing
- Vitamin D (Cholecalciferol )
- Where
- 2 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- University of Idaho
Mother-Child Relations, Substance Use
Optimizing Mental Health for Infants Exposed to Early Adversity: A Comparison of Breaking the Cycle and Maxxine Wright
The goal of this clinical trial is to compare the effectiveness of the Breaking the Cycle (BTC) and Maxxine Wright (MW) programs in substance-involved mothers and their children.
- Trial name
- NCT05768815
- Testing
- Breaking the Cycle Program, Maxxine Wright Program
- Where
- 2 sites in Canada
- Volunteers
- 100 people
- Sponsor
- University of Ottawa
Pregnancy, Primiparous Women
Maternal Reflective Functioning During the Transition to Motherhood
The goal of this clinical trial is to learn about Maternal Reflective Function (MRF) during the transition to motherhood. The main questions it aims to answer are: Does MRF mediates the connection between risk factors for mental…
- Trial name
- NCT06476626
- Testing
- Maternal Reflective Function Workshop
- Where
- Israel
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- University of Haifa
Postpartum Psychological Stress, Mindfulness-Based Stress Reduction
Effect of Mindfulness-Based Stress Reduction on Birth Memory and Perception of Traumatic Birth
This randomized controlled trial aims to evaluate the effects of a Mindfulness-Based Stress Reduction (MBSR) program on birth memory and perception of traumatic birth among women who have undergone vaginal delivery.
- Conditions
- Postpartum Psychological Stress, Mindfulness-Based Stress Reduction, Maternal Health, Traumatic Birth
- Trial name
- MBSR-BIRTH (NCT07018765)
- Testing
- Mindfulness-Based Stress Reduction (MBSR)
- Where
- Turkey (Türkiye)
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Kader ATABEY
Maturation of the Healthy Infant Intestinal Microbiota, Microbial Colonization
Bern Birth Cohort / Trajectory of Microbiota Maturation in Healthy Bern Infants - a Network Approach
Background: Intestinal microbiota composition is fundamental to human health and undergoes critical changes within the first two years of life.
- Conditions
- Maturation of the Healthy Infant Intestinal Microbiota, Microbial Colonization, Nutrition Disorder, Infant, Milk Expression, Breast
- Trial name
- BeBiCo (NCT04447742)
- Where
- Switzerland
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Cystic Fibrosis in Children, Siblings
Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, Resource Program: How Does it Work?
The goal of the clinical trial is to test whether a mental health program that is delivered through the Internet works well for children and adolescents with cystic fibrosis (CF) and their healthy siblings.
- Conditions
- Cystic Fibrosis in Children, Siblings, Mental Health, Internet-based Intervention
- Trial name
- iCF-PWR (NCT06020274)
- Testing
- Internet-delivered Cystic Fibrosis Mental Health Prevention, Wellness, and Resource (iCF-PWR) program
- Where
- 2 sites in Canada
- Volunteers
- 120 people
- Sponsor
- University of Regina
Family Resilience, Parent-Infant Bonding
Development and Evaluation of an Intelligent Parent-Infant Connection-Based Intervention to Strengthen Family Resilience in Preterm Infant Care
This study aims to develop, optimize, and evaluate the effectiveness of a family resilience intervention centered on intelligent parent-infant connection for parents of preterm infants.
- Conditions
- Family Resilience, Parent-Infant Bonding, Parents of Premature Infants, Intelligent Intervention
- Trial name
- NCT07373002
- Testing
- Intelligent Intervention to enhance Parent-Infant Connection and Family Resilience, Routine Care
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- National Defense Medical Center, Taiwan
Klinefelter Syndrome, Trisomy X
The eXtroardinarY Babies Study: Natural History of Health and Neurodevelopment in Infants and Young Children With Sex Chromosome Trisomy
This study is designed to research the natural history of neurodevelopment, health and early hormonal function in infants with XXY/Klinefelter syndrome, XYY, XXX and other sex chromosome variations in an effort to identify early…
- Conditions
- Klinefelter Syndrome, Trisomy X, XYY Syndrome, XXXY and XXXXY Syndrome
- Trial name
- NCT03396562
- Testing
- Assessments of Development and Growth
- Where
- 2 sites in United States
- Volunteers
- 300 people
- Sponsor
- University of Colorado, Denver
Cystic Fibrosis (CF), Fatigue
CF Wellness Program
This study is a pilot randomized control trial (RCT; N=80) comparing the Cystic Fibrosis Wellness Program (CFWP) to usual care (UC) to evaluate (1) Intervention Adherence (completion of the CFWP Coaching Sessions) (2) Study…
- Conditions
- Cystic Fibrosis (CF), Fatigue, Sleep Quality, Insomnia
- Trial name
- NCT07071324
- Testing
- CF Wellness Program
- Where
- 3 sites in United States
- Volunteers
- 80 people
- Sponsor
- Johns Hopkins University
Maternal Mental Health, Early Child Development
Mental Health Support Interventions for Mothers of Infants and Young Children
The goal of this clinical trial is to learn whether a maternal mental health support program can improve maternal mental health and child development when delivered through routine child healthcare services in community health…
- Conditions
- Maternal Mental Health, Early Child Development, Depressive Symptoms, Postpartum
- Trial name
- NCT07627373
- Testing
- Thinking Healthy Extended Program
- Where
- China
- Volunteers
- 440 people
- Sponsor
- Stanford University
Postpartum Complication, Postpartum
Postpartum Care in the NICU Multi-Site Breastfeeding
Parents of infants in the neonatal intensive care unit (NICU) face unique barriers to long-term breastfeeding and lactation. The physical and emotional demands of having a critically ill or premature newborn combined with the…
- Conditions
- Postpartum Complication, Postpartum, PTSD, PTSD (Childbirth-Related)
- Trial name
- PeliCaN (NCT07881731)
- Testing
- NICU-informed postpartum doula support
- Where
- 11 sites in United States
- Volunteers
- 640 people
- Sponsor
- Children's Hospital of Philadelphia
Major Depressive Disorder, Postpartum Depression
Maternal Mental Health Trial
Perinatal depression affects 10-15% of women postpartum and has a recurrence rate of 40%. Women who develop perinatal depression might be particularly susceptible to the rapid and large changes in sex steroid hormones…
- Trial name
- MAMA (NCT04685148)
- Testing
- Transdermal patch estradiol
- Where
- Denmark
- Volunteers
- 220 people
- Sponsor
- Vibe G Frøkjær, MD, PhD
Human Immunodeficiency Virus, Mental Disorder
Integrated Mental Health Care for Pregnant Women With HIV in Kenya: The Tunawiri Study
This study seeks to improve mental health, pregnancy, and HIV outcomes among pregnant and postpartum women living with HIV with common mental health disorders in Kenya.
- Trial name
- NCT06117163
- Testing
- Collaborative Care Model
- Where
- Kenya
- Volunteers
- 900 people
- Sponsor
- University of Colorado, Denver
Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse)
Preventing Vulnerable Child Syndrome in the NICU With Cognitive Behavioral Therapy (PreVNT Trial)
This study is being done to see if outcomes for both a premature infant's parents and the infant born prematurely who have spent time in the neonatal intensive care unit (NICU) can be improved through parent cognitive behavioral…
- Conditions
- Premature Infant, Mental Health Issue (E.G., Depression, Psychosis, Personality Disorder, Substance Abuse), Development, Child, Parent-Child Relations
- Trial name
- PreVNT (NCT03906435)
- Testing
- Cognitive Behavioral Therapy
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- University of Texas Southwestern Medical Center
Neonatal Hypoglycemia, Metabolic Complication
Pasteurised Donor Human Milk Supplementation for Term Babies
PRESENT is a multi-center randomised controlled trial that aims to assess whether access to pasteurized donor human milk as supplementary nutrition in the first five days of life for term infants born to women with diabetes in…
- Conditions
- Neonatal Hypoglycemia, Metabolic Complication, Cows Milk Allergy, Hospital Length of Stay
- Trial name
- PRESENT (NCT06993103)
- Testing
- Standard care Cow's milk based formula, Dietary Supplement: PDHM Pasteurised Donor Human Milk
- Where
- 4 sites in Australia
- Volunteers
- 1,444 people
- Sponsor
- The University of Queensland