[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"parents\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:parents":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,16,0,[8,58,86,155,182,212,237,264,288,339,368,410,441,472,494,522],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":29,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":57},"100620667","act-together-implementing-a-web-based-program-with-brief-coaching-for-parents-of-children-with-disabilities-in-pediatric-outpatient-clinics-100620667",false,"NCT07360600","ACT Together: Implementing a Web-Based Program With Brief Coaching for Parents of Children With Disabilities in Pediatric Outpatient Clinics","Inclusion Criteria (Parents of children with disabilities):\n\n1. Community-dwelling adults (aged ≥18 years) with primary caregiving responsibility for a child with disabilities (aged \\\u003C18 years) who is enrolled in a participating clinic;\n2. Expected to use services at the participating clinic at least once per week over the next three months;\n3. Willing to learn strategies to cope with emotions and thoughts; and\n4. Have access to a web-enabled device (e.g., smartphone, tablet, laptop, or desktop) with reliable internet access at home or in a public space (e.g., library).\n\nExclusion Criteria (Parents of children with disabilities):\n\n1. Cognitive, physical, sensory impairments, or language barriers (non-English speaking) that would impede participation;\n2. Suicidal intent or suicide attempt(s) within the past six months;\n3. Participation in another parent support research study at the time of recruitment; or\n4. More than three hospitalizations of either the parent or child within the past year, or other serious health concerns that would interfere with program engagement.\n\nInclusion Criteria (Occupational therapists):\n\n1. Be willing to participate in training, program implementation, and study evaluations; and\n2. Currently work in a pediatric clinic that serves at least 15 children who attend the clinic at least once per week.\n\nExclusion Criteria (Occupational therapists): N\u002FA","ALL","18 Years",{"count":18,"type":19},60,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this clinical trial is to evaluate the feasibility, usability, and preliminary benefits of implementing ACT Together for parents of children with disabilities in pediatric outpatient clinics. ACT Together includes six self-paced, web-based modules and brief weekly one-on-one coaching sessions led by a trained occupational therapist. The program is based on acceptance and commitment therapy (ACT), which teaches practical skills to help people handle stress and difficult thoughts or feelings while taking steps toward what matters to them.\n\nThe main questions this study aims to answer are:\n\n* Can parents and occupational therapists complete the study activities as planned (e.g., module completion, coaching sessions, and surveys)?\n* Is the program usable and acceptable\u002Fappropriate\u002Ffeasible to implement in this setting?\n* Do parents show improvements in mental health and coping-related outcomes after participating in the program?\n* What are the experiences and perspectives of parents and therapists regarding the program?\n\nParents as participants will:\n\n* Complete six self-paced web-based modules and brief weekly individual phone coaching sessions with a trained occupational therapist working in pediatric outpatient clinics.\n* Complete online questionnaires before starting and after completing the program.\n* Take part in one online interview about their experiences and perspectives on the program.\n\nOccupational therapists as participants will:\n\n* Complete therapist training materials and deliver brief individual phone coaching sessions to parent participants, including completing a post-session checklist.\n* Complete brief online questionnaires before starting and after delivering the program.\n* Take part in one online interview about their experiences and perspectives on the program.",[25,26,27,28],"Parents","Children With Disabilities","Stress","Depression",[30,31,32,33,34,35,36,37,38,39,40,41,42,43,44],"Acceptance and Commitment Therapy","web-based intervention","internet-based intervention","occupational therapist","parents","children with disabilities","depressive symptoms","stress","feasibility","acceptability","usability","implementation","mixed methods","Pilot Study","phone coaching","RECRUITING","2026-06-22",{"date":48,"type":49},"2026-06-23","ACTUAL",{"date":51,"type":49},"2026-03-18",{"date":53,"type":19},"2026-12",{"name":55,"class":56},"University of South Florida","OTHER",1,{"id":59,"slug":60,"hasResults":11,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":11,"sex":15,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":4,"studyType":20,"phases":70,"briefSummary":71,"conditions":72,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":57},"100456946","sensory-optimization-of-the-hospital-environment-100456946","NCT05230199","Sensory Optimization of the Hospital Environment","Multisensory Interventions to Improve Neurodevelopmental Outcomes of Preterm Infants Hospitalized in the Neonatal Intensive Care Unit","SOOTHE","Inclusion Criteria:\n\n* ≤ 32 weeks estimated gestational age (EGA)\n* recruited within the first week of life\n\nExclusion Criteria:\n\n* \\> 32 weeks EGA at birth\n* \\>7 days old\n* become wards of the state\n* have a suspected or confirmed congenital anomaly\n* face a high immediate threat of death, per the opinion of the attending physician.","1 Day","7 Days",{"count":69,"type":19},215,[22],"The long-term goal of this project is to improve the health and well-being of preterm infants and their parents. Although there is evidence to support positive multisensory interventions in the NICU, these interventions are often applied in an inconsistent manner, reducing their benefit. Through a rigorous and scientific process, we have developed a structured multisensory intervention program, titled Supporting and Enhancing NICU Sensory Experiences (SENSE), which includes specific doses and targeted timing of evidence-based interventions such as massage, auditory exposure, rocking, holding, and skin-to-skin care. The interventions are based on the infant's developmental stage and are adapted based on the infant's medical status and behavioral cues. The multisensory interventions are designed to be conducted during each day of NICU hospitalization by the parents, who are educated and supported to provide them. The proposed work aims to determine the effect of multisensory interventions on parent mental health, parent-child interaction, brain activity (amplitude integrated electroencephalography), and infant developmental outcomes through age 2 years, with specific attention to language outcome.",[73,74,25,75,76],"Preterm","Parent-Child Relations","Development, Infant","Sensory Integration Dysfunction","2026-06-15",{"date":79,"type":49},"2026-06-17",{"date":81,"type":49},"2023-05-29",{"date":83,"type":19},"2028-12-31",{"name":85,"class":56},"University of Southern California",{"id":87,"slug":88,"hasResults":11,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":15,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":4,"studyType":20,"phases":99,"briefSummary":100,"conditions":101,"keywords":118,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":145,"lastUpdatePostDateStruct":146,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":154},"100569405","advanced-wireless-sensors-for-neonatal-care-in-the-delivery-room-100569405","NCT06693817","Advanced Wireless Sensors for Neonatal Care in the Delivery Room","Advanced Wireless Sensors for Neonatal Care in the Delivery Room: the AWARD Prospective Multicenter International Study","AWARD","Inclusion criteria:\n\n1. Newborns ≥35 weeks (gestational age)\n2. Newborns determined to be clinically stable at delivery\n3. Newborns with no skin abnormalities\n\nExclusion criteria:\n\n1. Newborns ≤ 35 weeks (gestational age)\n2. Newborns determined to not be clinically stable at delivery\n3. Newborns with Skin abnormalities",true,"35 Weeks","42 Weeks",{"count":98,"type":19},600,[22],"The goals of this observational study is to assess whether a new advanced wireless skin sensor vital sign monitoring system can effectively monitor the vital signs of healthy newborn infants (≥ 35 weeks gestational age). The main aims of this Study are to:\n\n1. Assess feasibility\n2. Evaluate safety\n3. Determine accuracy of the wireless monitoring system, compared to the standard of care wired vital sign monitoring system, immediately after delivery and for the first 2h of age in the obstetrical center under unsupervised parents' care. The newborn infants participating in the Study will have both vital sign monitoring systems placed on their chest and limb. Their vital signs will be monitored for 2h consecutively.",[102,103,104,105,106,107,108,109,110,111,112,113,114,115,25,116,117],"Sudden Unexplained Infant Death","Apnea of Newborn","Newborn Morbidity","Newborn Asphyxia","Birth Outcome, Adverse","Birth Asphyxia","Pregnancy Related","Newborn; Vitality","ECG Electrode Site Reaction","Infant ALL","Infant Death","Infant, Newborn, Diseases","Infant Apnea","Infant Conditions","Delivery Problem for Fetus","Delivery Complication",[119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144],"Delivery Room","Newborn","Neonatal Resuscitation","Wireless Technology","Vital Sign Monitoring","Sudden Unexplained Post-Natal Collapse","SUPC","Obstetrical Center","Obstetrics","Neonate","Birth","Birthing Center","C-Section","Vaginal Delivery","Sensors","Heart Rate (HR)","Respiratory Rate (RR)","Blood Oxygen Saturation (SpO2)","Skin Temperature (Tskin)","Pulse Rate (PR)","International","Low-Income","Middle-Income","High-Income","Golden Hour","Post-Birth","2026-05-05",{"date":147,"type":49},"2026-05-08",{"date":149,"type":49},"2025-04-08",{"date":151,"type":19},"2027-12-30",{"name":153,"class":56},"Guilherme Sant'Anna, MD",5,{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":94,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":163,"targetDuration":4,"studyType":20,"phases":165,"briefSummary":166,"conditions":167,"keywords":168,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":173,"lastUpdatePostDateStruct":174,"startDateStruct":176,"completionDateStruct":178,"leadSponsor":180,"locationsCount":57},"100622463","resilient-families-feasibility-trial-100622463","NCT07383948","Resilient Families Feasibility Trial","Enhancing Parental Well-being in the NICU","R-FAM","Inclusion Criteria:\n\n* Adult parent\u002Flegal guardian (and\u002For their partner) of a baby admitted to the NICU within past week (age ≥ 18)\n* Currently in an intimate relationship and will live with baby after NICU discharge\n* At least one dyad member is emotionally distressed (GAD\\>=10 or PHQ \\>= 10)\n* English fluency\u002Fliteracy\n* Ability and willingness to participate via live video\n\nExclusion Criteria:\n\n* Baby is expected to pass away (as determined by medical team)\n* Current, untreated psychosis or substance dependence\u002Fabuse\n* Current self-report of suicidal ideation",{"count":164,"type":19},50,[22],"The goal of this study is to test the feasibility and acceptability of a dyadic, resiliency intervention (\"Resilient Families;\" R-FAM) that aims to reduce emotional distress and improve relationships among parents in the Neonatal Intensive Care Unit (NICU). To achieve this goal, the investigators are developing a randomized control trial where patients will be randomized to either the R-FAM condition or a minimally enhanced usual control (MEUC), which includes resources on parent mental health and coping in the NICU.",[25],[169,170,171],"Neonatal Intensive Care Unit","Parent Mental Health","Parent relationships","NOT_YET_RECRUITING","2026-02-02",{"date":175,"type":49},"2026-02-04",{"date":177,"type":19},"2026-03-01",{"date":179,"type":19},"2028-03-31",{"name":181,"class":56},"Massachusetts General Hospital",{"id":183,"slug":184,"hasResults":11,"nctId":185,"briefTitle":186,"officialTitle":187,"acronym":188,"eligibilityCriteria":189,"healthyVolunteers":94,"sex":190,"minAge":16,"maxAge":4,"enrollmentInfo":191,"targetDuration":4,"studyType":20,"phases":193,"briefSummary":194,"conditions":195,"keywords":197,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100621020","online-parenting-support-with-vipp-sd-in-chile-100621020","NCT07365189","Online Parenting Support With VIPP-SD in Chile","Effectiveness of the Online Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (Online VIPP-SD). A Randomized Control Trial in Chile","VIPP-SD Chile","Inclusion Criteria:\n\n* Mothers \\>18 years\n* Child age between 11 - 16 months old at first contact\n* Mothers scoring in the top 30% of our sample on the Parental Burnout Scale (BPPS)\n* Written informed consent of mothers as participants and guardians\n* Internet connection at mother's home.\n\nExclusion Criteria:\n\n* Child or parent with severe sensory impairment, learning disability, or language limitation\n* Sibling already participating in the trial\n* Family participating in active family court proceedings\n* Parent participating in another closely related research trial and\u002For receiving an individual video-feedback intervention.","FEMALE",{"count":192,"type":19},140,[22],"The goal of this randomized controlled trial is to test whether the online Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline (VIPP-SD) can reduce parental burnout and improve parenting practices, in mothers of young children in Chile.\n\nThe main questions it aims to answer are:\n\n* Does the online VIPP-SD increase maternal sensitivity and the use of consistent but gentle limit setting?\n* Does it reduce parental burnout?\n* Does it improve parental stress and child attachment security and reduce child conduct problems? Researchers will compare families who receive the online VIPP-SD to families in a waitlist control group with dummy treatment to see if VIPP-SD has benefits for parents and children.\n\nParticipants will be mothers of children aged 11-16 months at the start of the study who report elevated levels of parental burnout. Mothers in the intervention group will:\n\n* Take part in 12 weekly online sessions with a trained intervener\n* Receive video-feedback on their own interactions with their child\n* Learn strategies to respond sensitively to their child's needs and to use positive discipline The study will also measure potential moderators such as maternal mental health, child temperament, and family sociodemographic factors.",[25,196],"Burnout",[198,199,200,201,202],"VIPP-SD online","maternal sensitivity","parental burnout","infant attachment","parental limit-setting","2026-01-15",{"date":205,"type":49},"2026-01-26",{"date":207,"type":19},"2026-01-01",{"date":209,"type":19},"2028-03-30",{"name":211,"class":56},"Universidad San Sebastián",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":20,"phases":222,"briefSummary":223,"conditions":224,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":57},"100551182","text-messaging-intervention-to-support-parents-after-their-childs-psychiatric-emergency-100551182","NCT06456762","Text-messaging Intervention to Support Parents After Their Child's Psychiatric Emergency","Developing and Testing a Text-messaging Intervention to Support Parents After Their Child's Psychiatric Emergency","iPEACE","Inclusion Criteria:\n\n* Parents or legal guardians of a child ages 11-17;\n* Parents or legal guardians must live with their child ≥50% of the time;\n* Child must be admitted to the pediatric emergency department for a mental health crisis;\n* Child must be discharged home from the emergency department with referrals to outpatient care.\n\nExclusion Criteria:\n\n* Do not have daily access to a mobile phone that can receive SMS text messages;\n* Do not speak and read fluently in English.",{"count":221,"type":19},90,[22],"This grant aims to develop and test a text-messaging intervention for parents of children and teens evaluated in the emergency department for a psychiatric emergency and discharged home with outpatient referrals. The intervention for parents will teach parents skills to navigate the mental health services system and build their self-efficacy in managing their child's mental health. This research has the potential to improve services for families seeking emergency psychiatric support, with the goal of facilitating treatment engagement and reducing emergency services utilization using scalable, cost-effective, accessible tools.",[25,225,226,227],"Self Efficacy","Mental Health Literacy","Psychiatric Emergency","2025-11-05",{"date":230,"type":49},"2025-11-10",{"date":232,"type":49},"2024-08-01",{"date":234,"type":19},"2026-12-31",{"name":236,"class":56},"Vanderbilt University Medical Center",{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":4,"eligibilityCriteria":243,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":244,"targetDuration":4,"studyType":246,"phases":4,"briefSummary":247,"conditions":248,"keywords":251,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":57},"100603912","changes-in-the-dietary-patterns-of-adults-in-care-of-a-newly-diagnosed-type-1-diabetes-mellitus-child-100603912","NCT07142681","Changes in the Dietary Patterns of Adults in Care of a Newly Diagnosed Type 1 Diabetes Mellitus Child","Changes in the Dietary Patterns of Adults in Family Units With a Newly Diagnosed Type 1 Diabetes Mellitus Child: Impact of Educational Actions Derived From Standard Care","Inclusion Criteria:\n\n* Over 18 years old\n* Parents or legal tutors of a child with type 1 diabetes (according to ADA criteria).\n* Less than 1 week since the type 1 diabetes diagnostic.\n* Living together more than 40%of the time with the infant with type 1 diabetes.\n* Be the adult responsible for most of the family meals.\n\nExclusion Criteria:\n\n* Parents of infants with other types of diabetes (type 2, MODY, gestational, others).\n* Household members with diseases or conditions that can affect dietary habits (type 2 diabetes, kidney disease, pregnancies).\n* Significant dietary habit modifications (change to a vegeterian, vegan, palea, or other diets, fasting situations) in the last month prior to the diagnosis of type 1 diabetes.",{"count":245,"type":19},26,"OBSERVATIONAL","The goal of this observational study is to compare the feeding pattern evolution in parents whose children have been newly diagnosed with type 1 diabetes mellitus, versus one year later. The main question it aims to answer is:\n\n\\- Does the dietary intervention in the pediatric population affect the parent's diet?",[249,25,250],"Dietary Habits","Diabetes Mellitus, Type 1",[252,253,254,250],"diet","dietary habits","nutritional intervention","2025-08-26",{"date":257,"type":49},"2025-08-27",{"date":259,"type":49},"2024-05-29",{"date":261,"type":19},"2027-05",{"name":263,"class":56},"Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":272,"targetDuration":4,"studyType":20,"phases":274,"briefSummary":275,"conditions":276,"keywords":278,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":279,"lastUpdatePostDateStruct":280,"startDateStruct":282,"completionDateStruct":284,"leadSponsor":286,"locationsCount":57},"100594664","feasibility-and-acceptability-of-the-technology-based-enhanced-gender-support-platform-implementation-with-parents-100594664","NCT07022392","Feasibility and Acceptability of the Technology Based Enhanced Gender Support Platform Implementation With Parents","Feasibility and Acceptability of the Technology Based Enhanced Gender Support Platform Implementation","TEGS","Inclusion Criteria:\n\n* Parent of a gender diverse youth aged 8-17\n* Has access to the internet\n* Can speak or read English\n\nExclusion Criteria:\n\n* Not a parent of a gender diverse youth aged 8-17\n* No access to the internet\n* Cannot speak or read in English",{"count":273,"type":19},36,[22],"This is a small pilot feasibility and acceptability study of implementing a Technology-Enhanced Gender Support (TEGS) platform with parents and caregivers. Parents and caregivers who consent to participate will complete an electronic survey at baseline. They will then receive access to the TEGS platform and complete follow up surveys 1 mo and 3 mo after. Each participant will also be given the option to participate in an exit interview.",[25,277],"Usability",[34],"2025-06-18",{"date":281,"type":49},"2025-06-24",{"date":283,"type":19},"2025-10-01",{"date":285,"type":19},"2026-03-31",{"name":287,"class":56},"Seattle Children's Hospital",{"id":289,"slug":290,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":94,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":246,"phases":4,"briefSummary":298,"conditions":299,"keywords":310,"overallStatus":172,"whyStopped":4,"lastUpdateSubmitDate":330,"lastUpdatePostDateStruct":331,"startDateStruct":333,"completionDateStruct":335,"leadSponsor":337,"locationsCount":57},"100579648","global-survey-on-newborns-hospitalisation-and-parental-experiences---the-hope-study-100579648","NCT06827028","Global Survey on Newborns' HOspitalisation and Parental Experiences - the HOPE Study","Global Survey on Newborns' HOspitalisation and Parental Experiences","HOPE","Inclusion Criteria:\n\nParent or caregiver of a newborn infant born on January 1, 2023, or thereafter, who received\u002Fis receiving special\u002Fintensive care starting within the first week of life such as oxygen therapy or other respiratory support, incubator treatment, intravenous infusions, treatment of (suspected) sepsis, pneumonia, necrotising enterocolitis, malformations, jaundice, nutritional\u002Ffeeding problems, hypoglycemia, etc.\n\nExclusion Criteria:\n\n* Other family members than parents\u002F(primary) caregivers\n* Parents of newborns that did not receive special\u002Fintensive care starting within the first week of life\n* Parents or caregivers of infants born before 1 January 2023\n* Persons with insufficient proficiency of one of the languages of the questionnaire",{"count":297,"type":19},100,"This study aims to explore parents' experiences and emotional burdens related to their newborn's hospital stay using an online survey. Our target population consists of parents of newborns born preterm, with low birthweight, or critically ill. Particularly the presence of infant- and family-centred developmental care (IFCDC) principles as well as support through political framework conditions will be investigated.",[300,301,25,302,303,304,305,306,307,308,309],"Infant, Premature","Infant, Low Birth Weight","Life Change Events","Needs Assessment","Anxiety","Fear","Stress, Psychological","Uncertainty","Emotions","Caregiver Burden",[311,312,313,314,315,316,317,318,319,303,320,25,321,322,323,324,325,326,327,328,329],"Parental needs","Infant- and Family-centred developmental care","IFCDC","EFCNI","NICU","Global Parent Survey","Breastfeeding","Breastfeeding support","Politics","HRQoL","Infant, Newborn","Family","Family Support","Family Health","Intensive Care, Neonatal","Patient-Centered Care","Infant Care","Surveys and Questionnaires","Health Care Surveys","2025-04-24",{"date":332,"type":49},"2025-04-27",{"date":334,"type":19},"2025-09-01",{"date":336,"type":19},"2027-12-31",{"name":338,"class":56},"Global Foundation for the Care of Newborn Infants",{"id":340,"slug":341,"hasResults":11,"nctId":342,"briefTitle":343,"officialTitle":343,"acronym":4,"eligibilityCriteria":344,"healthyVolunteers":11,"sex":15,"minAge":345,"maxAge":346,"enrollmentInfo":347,"targetDuration":4,"studyType":20,"phases":349,"briefSummary":350,"conditions":351,"keywords":352,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":359,"lastUpdatePostDateStruct":360,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":57},"100526721","group-cbt-in-parents-of-children-with-food-allergy-100526721","NCT06138431","Group CBT in Parents of Children With Food Allergy","Inclusion Criteria:\n\n1. Parent, age \\>18yrs\n2. All genders\n3. Child must be aged 18 months - 17yrs with serious food allergy(ies), medically diagnosed\n4. Meets cut-offs for anxiety and\u002For depression on the Hospital Anxiety and Depression Scale (need to define)\n5. Parent can be on stable doses of antidepressants or anxiety medications but all doses must remain stable for 1 month before study and during it as well as for 2 months after the groups are completed: to fill out final questionnaires\n6. Both parents of a child may enroll but will need to agree to fill out all questionnaires separately without discussing them with each other\n\nExclusion Criteria:\n\n1. Parental history of recent suicidal ideation \u002F suicide attempt\n2. Current Suicidal ideation\n3. Current substance abuse\n4. Parent currently in psychiatric treatment and medications being adjusted\n5. Using OTC anxiety or depression relief, or CBD or medical marijuana\n6. Parent receiving other therapies or group supports\n7. Parent unable to attend 6 consecutive weekly group sessions and fill out questionnaires online also 2 months later or does not have access to WiFi.","18 Months","17 Years",{"count":348,"type":19},10,[22],"Parents of children with food allergies that are medically established will be able to participate in 6 one-hour weekly virtual Cognitive Behavioral Therapy (CBT) groups, and outcomes will be measured for anxiety, depression and quality of life. Possible benefits include improvement in psychological functioning and quality of life of families, as well as improved understanding of the use of group Cognitive Behavioral Therapy (CBT) for parents of children with medically established food allergies.",[25],[34,353,354,355,356,357,358],"children","food","allergies","CBT","cognitive","therapy","2025-04-13",{"date":361,"type":49},"2025-04-16",{"date":363,"type":49},"2023-06-19",{"date":365,"type":19},"2025-12-31",{"name":367,"class":56},"University of Missouri, Kansas City",{"id":369,"slug":370,"hasResults":11,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":374,"eligibilityCriteria":375,"healthyVolunteers":11,"sex":15,"minAge":376,"maxAge":4,"enrollmentInfo":377,"targetDuration":4,"studyType":246,"phases":4,"briefSummary":379,"conditions":380,"keywords":387,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":400,"lastUpdatePostDateStruct":401,"startDateStruct":403,"completionDateStruct":405,"leadSponsor":407,"locationsCount":409},"100584246","parental-well-being-after-childbirth-in-switzerland-100584246","NCT06886841","Parental Well-being After Childbirth in Switzerland","Stress Of Co-parents Related to A Traumatic Experience of Birth Across Switzerland","SOCRATES","Inclusion criteria:\n\n* Women who give birth in a participating maternity unit or birth center during the study period.\n* Partner of a participating women: the partner must be designated by the mother, live with her at the time of birth, and only one partner can be included per mother.\n* Gestational age at birth: ≥22+0 weeks and\u002For birthweight ≥500 grams\n* Age: Participants must be 14 years or older.\n* Language Proficiency: Participants must have sufficient proficiency in one of Switzerland's main official languages (German, French, Italian) or English to ensure accurate communication and comprehension of study materials.\n\nExclusion Criteria:\n\n* Refusal to participate\n* Inability to provide informed consent","14 Years",{"count":378,"type":19},4200,"Improving maternal and child health is a global priority, with increasing emphasis on ensuring women and their families not only survive but also thrive after childbirth. While high-income countries like Switzerland provide strong antenatal and intrapartum care, the quality of postnatal care often lags behind, despite the critical physical, mental, and social needs of the postpartum period. Studies indicate high rates of mental distress, physical pain, and sexual discomfort among mothers, alongside a lack of research on the well-being of co-parents.\n\nThe main question this cohort study aims to answer is: how do the health and well-being of mothers and co-parents evolve during the first year after childbirth? Participants will complete four online questionnaires: the first within the first few days after birth, followed by additional assessments at 2, 6, and 12 months postpartum.\n\nThis comprehensive approach seeks to inform policy and improve evidence-based postnatal care practices, benefiting approximately 80,000 families annually in Switzerland.",[381,382,383,25,384,385,386],"Mental Health","Physical Health","Postpartum","Quality of Life","Quality of Care","Stress Disorder, Post Traumatic",[388,389,390,391,392,393,394,395,396,397,398,399],"childbirth-related post-traumatic stress disorder","mental health","postpartum","parental wellbeing","physical health","sexual health","social support","quality of life","quality of care","postpartum depression","mothers","coparents","2025-03-19",{"date":402,"type":49},"2025-03-20",{"date":404,"type":49},"2025-03-17",{"date":406,"type":19},"2026-06",{"name":408,"class":56},"Laurent Gaucher",2,{"id":411,"slug":412,"hasResults":11,"nctId":413,"briefTitle":414,"officialTitle":415,"acronym":4,"eligibilityCriteria":416,"healthyVolunteers":11,"sex":15,"minAge":417,"maxAge":418,"enrollmentInfo":419,"targetDuration":4,"studyType":20,"phases":421,"briefSummary":422,"conditions":423,"keywords":427,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":433,"lastUpdatePostDateStruct":434,"startDateStruct":436,"completionDateStruct":438,"leadSponsor":439,"locationsCount":409},"100515912","a-parent-child-yoga-intervention-for-reducing-attention-deficits-in-children-with-congenital-heart-disease-a-feasibility-study-100515912","NCT05997680","A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study","A Parent-child Yoga Intervention for Reducing Attention Deficits in Children with Congenital Heart Disease: a Feasibility Study Prior to a Randomised Controlled Trial","To be eligible for the study, children need to meet the following inclusion criteria:\n\n1. diagnosis of CHD requiring heart surgery;\n2. aged 4 to 6 years old;\n3. poor attentional skills measured with Variability score (0.5 standard deviation below norms) at the Kiddie Conners Continuous Performance Test, 2nd Edition (K-CPT2), a sensitive measure for attentional impairments. This inclusion criteria is important since yoga intervention has shown larger effects on attention in children with greater difficulties before the intervention;\n4. parent willing to participate to the 8-week parent-child yoga intervention and the pre\u002Fpost\u002F6-month follow-up assessments;\n5. for children with ADHD medication (approx. 5% of the 4-to-6-year-olds at our neurocardiac clinic), parent accept to temporary stop it to at least 48h prior to each assessment.\n\nExclusion criteria will be the following:\n\n1. having a medical contraindication to the practice of yoga;\n2. confirmed diagnosis of severe developmental or intellectual delay that would prevent successful completion of the planned study testing;\n3. presence of severe physical handicap that would preclude the child from participating in the yoga intervention without special adaptation;\n4. families who do not speak French or English (less than 3% of families followed in our clinics);\n5. children who have been engaged in a structured weekly yoga program for at least a month in the past year (based on our parents' poll, less than 5%). However, parents included could have past or actual experience in practicing yoga.\n\nEligibility will be determined:\n\n1. by consulting the child's medical record;\n2. during a child medical visit at one of the sites or a virtual visit with the research team by administering the K-CPT2.","4 Years","6 Years",{"count":420,"type":19},24,[22],"The proposed study aims to determine the feasibility of the procedures for a future full randomized controlled trial (RCT), which will test the efficacy of a parent-child yoga intervention in reducing attention deficits in children with congenital heart disease (CHD). Specific aims of this single-blind, two-arm, two-center feasibility trial are to evaluate recruitment rates and capacity, withdrawal and dropout rates, adherence to the intervention, acceptability of the randomization process by families, variation in delivery of the intervention between yoga instructors, and standard deviation of main outcomes of the future RCT in order to determine its appropriate sample size. This feasibility study will lead to the first ever RCT to test the efficacy of an intervention strategy for reducing attention deficits in children with CHD. Ultimately, the implementation of this parent-child yoga program will lead to better long-term academic and psychosocial functioning and quality of life for these children and their family.",[424,425,426,25],"Congenital Heart Disease","Child Development","Neurodevelopmental Disorders",[428,429,430,431,432,424],"Neurodevelopment","Attention","Yoga","Motor Skills","Parenting Stress","2024-11-26",{"date":435,"type":49},"2024-11-29",{"date":437,"type":49},"2023-10-01",{"date":283,"type":19},{"name":440,"class":56},"Anne Gallagher",{"id":442,"slug":443,"hasResults":11,"nctId":444,"briefTitle":445,"officialTitle":446,"acronym":4,"eligibilityCriteria":447,"healthyVolunteers":11,"sex":15,"minAge":448,"maxAge":346,"enrollmentInfo":449,"targetDuration":4,"studyType":20,"phases":451,"briefSummary":452,"conditions":453,"keywords":458,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":464,"lastUpdatePostDateStruct":465,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":470,"locationsCount":57},"100540097","the-via-family-20---a-family-based-intervention-for-families-with-parental-mental-illness-100540097","NCT06312410","The VIA Family 2.0 - a Family Based Intervention for Families with Parental Mental Illness","The VIA Family 2.0 Study: a Randomized Clinical Trial Evaluating Family-based Interventions for Children Born to Parents with Mental Disorders","Inclusion Criteria:\n\n* At least one of the parents must be living in Capital Region or in Region North, Denmark, and at least one biological child under age 18 must be living with one of the parents. Only biological children of the parent with at mental health problem can be included.\n* The parent with the mental health problems has at some point been diagnosed in the secondary sector and has within the last three years been treated in the primary sector (GP or private psychiatric clinic) or in the secondary sector (hospital psychiatry).\n* Patients with substance abuse can only be included if substance abuse is a secondary diagnosis to another mental illness disorder being treated within the secondary sector during the last three years.\n* All adult participants must give informed consent. Both parents will need to consent in case of shared custody, but do not have to participate if they are reluctant to do so.\n\nExclusion Criteria:\n\n* Not fulfilling inclusion criteria\n* Not giving informed consent\n* Living at Læsø or at Bornholm, Denmark\n* Children placed in care outside of the home fulltime in institution of professional family care (the family is not excluded if the children placed in part time in care outside home or fulltime family care within the family)\n* No risk factors found after baseline assessment (as described in the stepped care model) at baseline - these families can be re-referred if their situation changes.\n* Ongoing intensive family treatment in the municipality (for example staying at an institution for parental evaluation by the authorities)?","0 Years",{"count":450,"type":19},1452,[22],"VIA Family 2.0 - a Family Based Intervention for families with parental mental illness\n\nBackground: Children born to parents with mental illness have consistently been shown to have increased risks for a range of negative life outcomes including increased frequencies of mental disorders, somatic disorders, poorer cognitive functioning, social, emotional and behavioral problems and lower quality of life. Further these children are often overlooked by both society and mental health services, although they represent a potential for prevention and early intervention.\n\nA collaboration between researchers and clinicians from two regions, the Capital Region and the North Region Denmark has been established as the Research Center for Family Based Interventions. The research center is an umbrella for a series of research activities, all focusing on children and adolescents in families with parental mental illness.\n\nMethod: A large randomized, controlled trial (RCT) for families with parental mental illness will be conducted in order to evaluate the effect of a two-year multidisciplinary, holistic team intervention (the VIA Family 2.0 team intervention) against treatment as usual (TAU). Inclusion criteria will be biological children 0-17 of parents with any mental disorder treated in the secondary sector at any time of their life and receiving treatment in primary or secondary sector within the previous three years. A total of 870 children or approx. 600 families will be included from two sites. Primary outcomes will be changes in child well being, parental stress, family functioning and quality of the home environment, .\n\nTime plan: The RCT will start including families from March 1st, 2024 to Dec 2025 (or later if needed). All families will be assessed at baseline and at end of treatment, i.e. after 24 months and after 36 months. Baseline data will inform the intervention team about each family's needs, problems, and motivation. TAU will be similar in the two regions, which means three family meetings and option for children to participate in peer groups.\n\nChallenges: final funding is being applied for. Recruitment of families can be challenging but we have decades of experience in conducting research in the field. Since both the target group, their potential problems and the intervention is complex, primary outcome is difficult to determine.",[454,25,455,456,457],"Child","Mental Disorder","Child of Impaired Parents","Preventive Health Services",[459,460,461,462,463],"family based intervention","early intervention","familial high risk","COPMI - children of parents with mental illness","parental mental illness","2024-10-23",{"date":466,"type":49},"2024-10-26",{"date":468,"type":49},"2024-03-18",{"date":83,"type":19},{"name":471,"class":56},"Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital",{"id":473,"slug":474,"hasResults":11,"nctId":475,"briefTitle":476,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":11,"sex":190,"minAge":4,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":246,"phases":4,"briefSummary":481,"conditions":482,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":485,"lastUpdatePostDateStruct":486,"startDateStruct":488,"completionDateStruct":490,"leadSponsor":492,"locationsCount":57},"100560053","prevalence-of-parental-burnout-among-mothers-of-children-with-cerebral-palsy-100560053","NCT06572137","Prevalence of Parental Burnout Among Mothers of Children With Cerebral Palsy","Prevalence of Parental Burnout Among Mothers of Children With Cerebral Palsy: Cross Sectional Study","Inclusion Criteria:\n\n* Mothers of children with CP of any age.\n* Children diagnosed with CP.\n* The age of children will range from 3-18 years old.\n\nExclusion Criteria:\n\n* Mothers who refuse to participate in the study.\n* Mothers of more than one disabled child.",{"count":480,"type":19},380,"This study will be done to determine the prevalence of Parental Burnout among mothers of children with cerebral palsy.\n\nDetermine the relation between Parental Burnout syndrome and the motor function levels of children with cerebral palsy.",[25,196,483,484],"Children, Only","Cerebral Palsy","2024-08-23",{"date":487,"type":49},"2024-08-26",{"date":489,"type":49},"2024-07-01",{"date":491,"type":19},"2025-01-01",{"name":493,"class":56},"Cairo University",{"id":495,"slug":496,"hasResults":11,"nctId":497,"briefTitle":498,"officialTitle":498,"acronym":499,"eligibilityCriteria":500,"healthyVolunteers":94,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":501,"targetDuration":503,"studyType":246,"phases":4,"briefSummary":504,"conditions":505,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":512,"lastUpdatePostDateStruct":513,"startDateStruct":515,"completionDateStruct":517,"leadSponsor":519,"locationsCount":521},"100491393","danish-diabetes-birth-registry-2-100491393","NCT05678543","Danish Diabetes Birth Registry 2","DDBR2","Inclusion Criteria:\n\n* Women, age ≥ 18 years\n* Type 1 diabetes, type 2 diabetes or other types of pre-existing diabetes (e.g., maturity onset diabetes of the young (MODY))\n* Partners of women fulfilling these inclusion criteria, age ≥ 18 years\n* Offspring of women fulfilling these inclusion criteria\n\nExclusion Criteria:\n\n* No proficiency in Danish or English to understand oral and written information",{"count":502,"type":19},2500,"10 Months","Pregnancies in women with pre-existing diabetes are considered \"high risk\" pregnancies, poses daily clinical challenges and in terms of research - a number of unanswered questions. Therefore, the investigators wish to establish a nationwide cohort of pregnancies complicated by pre-existing diabetes - the Danish Diabetes Birth Registry (DDBR2) The DDBR2 registry comprises all types of pre-existing diabetes including T1D, T2D and other types (as MODY), generating a nationwide cohort of mother\u002Fpartner\u002Fchildren trios with accessible registry-, clinical data and biological biobank samples. This will enable the investigators to use data longitudinally to examine short- and long-term outcomes of pregnancies in women with diabetes.",[506,507,508,25,509,510,511,322],"Pregnancy in Diabetic","Type 1 Diabetes","Type 2 Diabetes","Fetal Complications","Maternal Diabetes","Birth Injuries","2024-04-11",{"date":514,"type":49},"2024-04-12",{"date":516,"type":49},"2023-01-01",{"date":518,"type":19},"2030-12-31",{"name":520,"class":56},"Odense University Hospital",4,{"id":523,"slug":524,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":94,"sex":190,"minAge":530,"maxAge":531,"enrollmentInfo":532,"targetDuration":4,"studyType":20,"phases":534,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":539,"lastUpdatePostDateStruct":540,"startDateStruct":541,"completionDateStruct":543,"leadSponsor":545,"locationsCount":409},"100543987","supporting-at-risk-mothers-across-perinatal-period-100543987","NCT06363019","Supporting At-Risk Mothers Across Perinatal Period","Supporting At-Risk Mothers Across Perinatal Period: A Randomized Controlled Trial","SMART","Inclusion Criteria:\n\n* mothers who (1) are 21 years old to 65 years old; (2) can read and speak English; (3) belong to a vulnerable population due to one or more of the following criteria: i) monthly household income is =\u002Fless than SGD 2500 and\u002For under any low-income support services (referral from social workers) ii) have positive maternal Adverse Childhood Events (ACES) evaluation; iii) single mother; iv) clinically referred by medical professionals or other allied workers for requiring psychosocial support; v) pregnancy or birth of baby diagnosed with congenital malformation\u002Fabnormality where baby is 1 year old or less and can be discharged home with mother; vi) mothers with Edinburgh Postnatal Depression Scores (EPDS) =9 (at-risk for depression); and (4) have a smartphone with internet access.\n\nExclusion Criteria:\n\n* mothers who (1) have chronic physical or mental disorders which would interfere with their ability to participate in the study, and\u002For (2) gave birth to a baby who needs prolonged hospitalization or NICU support and \u002For stillborn (3) has a cognitive impairment","21 Years","65 Years",{"count":533,"type":19},200,[22],"The SMART app is a mobile application based psychosocial parenting intervention containing educational materials (articles, videos, audios, podcasts) on parenting, an integrated peer support chat function with experienced mothers and an integrated forum for interaction with other mother participants.\n\nThe goal of this interventional study is to test the effectiveness of a mobile-app health based intervention, SMART, mothers in the perinatal period.\n\nThe main questions this study aims to answer are:\n\n1. What is the effect of a mobile-based health intervention, SMART, on maternal outcomes?\n2. What is the effect of a mobile-based health intervention, SMART, on infant outcomes?\n3. What is the cost-effectiveness of using SMART as compared to standard routine care?\n\nResearchers will compare results with a control group that will undergo standard routine care.",[537,25,304,225,27,538],"Perinatal Depression","Infant Development","2024-04-09",{"date":514,"type":49},{"date":542,"type":49},"2024-02-26",{"date":544,"type":19},"2026-07-06",{"name":546,"class":56},"National University of Singapore"]