[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"child-mental-health\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:child-mental-health":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,48,85,111,149,202,231,264],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100053377","cohort-network-for-adolescents-and-youth-with-multiple-mental-health-conditions-100053377",false,"NCT07699159","Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions","Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM): A Master Observational Trial","CALM","Inclusion Criteria:\n\nThe participant must meet all of the inclusion criteria to be eligible for this research study:\n\n* Light Phenotype Eligibility Must sign and date the informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent; Aged 11-24 years old at the time of screening; Any person within age criteria who has previously sought, is seeking, or is accessing mental health services; Are able to complete assessments in English.\n\nDeep Phenotype Eligibility Must be part of the CALM light phenotype cohort; Must sign and date the deep phenotyping informed consent form, or provide assent and have a Substitute Decision Maker provide informed consent.\n\nLight Phenotype Caregiver Participant Eligibility:\n\nAny caregiver of a CALM child\u002Fyouth participant is eligible to participate in the study, insofar as the child\u002Fyouth participant has consented to the light phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.\n\nDeep Phenotype Caregiver Participant Eligibility:\n\nAny caregiver of a CALM child\u002Fyouth participant is eligible to participate in the study, insofar as the child\u002Fyouth participant has consented to the deep phenotype cohort and has agreed for their caregiver to be contacted to participate in the study; Must sign and date the informed consent form.\n\nExclusion Criteria:\n\nAn individual who meets any of the following criteria will be excluded from participation in this research study:\n\nLight Phenotype Does not provide informed consent (for those with the capacity to consent) or assent (for those who lack the capacity to consent); For those individuals who lack the capacity to consent, the inability of the parent\u002Flegal guardian to provide informed consent for the youth is also an exclusion criterion; Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.\n\nDeep Phenotype Unable to participate in deep phenotyping protocol (e.g., MRI contraindication, uncorrected vision or hearing impairments that would interfere with data collection, unwillingness to complete assessments); No exclusion criteria are based on race, ethnicity, sex or gender.\n\nLight Phenotype Caregiver Participant Ineligibility:\n\nCaregivers of CALM child\u002Fyouth participants are ineligible to participate in the study if:\n\nThe child\u002Fyouth participant does not agree for their caregiver to be contacted to participate in the study; The child\u002Fyouth participant is not participating in the light phenotype cohort; Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.\n\nDeep Phenotype Caregiver Participant Ineligibility:\n\nCaregivers of CALM child\u002Fyouth participants are ineligible to participate in the study if:\n\nThe child\u002Fyouth participant does not agree for their caregiver to be contacted to participate in the study; The child\u002Fyouth participant is not participating in the deep phenotype cohort (i.e., is only participating in the light phenotyping cohort); Does not provide informed consent (for those with the capacity to consent). Those who lack capacity to consent include individuals who are non-verbal or unable to speak any English.","ALL","11 Years","24 Years",{"count":21,"type":22},1620,"ESTIMATED","OBSERVATIONAL","The Cohort Network for Adolescents and Youth With multipLe Mental Health Conditions (CALM) Master Observational Trial is a prospective, longitudinal observational study that seeks to improve clinical care for youth with multiple mental health conditions (MMHC), also known as mental health multimorbidity in the literature. MMHC is conceptualized as the presence of two or more mental health diagnoses under the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5). MMHC is common in youth seeking mental health services and is associated with less favorable outcomes and greater health services utilization. Mental health disorders also accumulate in youth over time. The Master Observational Trial (MOT) will investigate MMHC in critical developmental periods in youth and identify risk and protective factors that will provide a mechanistic understanding of how MMHC develops over time. A subset of participants will also enroll in a Deep Phenotyping Cohort, which includes enhanced clinical and cognitive assessments and multimodal neuroimaging to investigate neurobiological mechanisms underlying MMHC and identify potential biomarkers of illness complexity and progression.\n\nIn the near future, we aim to add to the current protocol to embed both a clinical trials network for youth mental health in Ontario and Calgary within the CALM study and add digital phenotyping using wearable technology to generate digital and physiological markers of MMHC. The current protocol focuses on establishing the longitudinal MOT cohort and Deep Phenotype Cohort only as a first step towards these long term CALM goals.",[26,27,28],"Multiple Mental Health Conditions","Child Mental Health","Youth Mental Health",[30,31,32,33,34],"multiple mental health conditions","child and youth mental health","mental health multimorbidity","master observational trial","deep phenotyping cohort","RECRUITING","2026-07-07",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2025-03-04",{"date":43,"type":22},"2028-03-31",{"name":45,"class":46},"Centre for Addiction and Mental Health","OTHER",6,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100642279","experimental-evidence-of-the-impact-of-parental-income-on-child-mental-health-and-neuroimmune-function-100642279","NCT07641244","Experimental Evidence of the Impact of Parental Income on Child Mental Health and Neuroimmune Function","Inclusion Criteria:\n\n* Child of a participant enrolled in the Every Dollar Counts intervention. Youth were between ages 5 and 14 at the start of the intervention (followed up when ages 10 to 18)\n* Biological parent who lives with the child must be part of the original income study\n* For the in-person neuroimaging subsample: family must live within a 2-hour drive of downtown Chicago\n\nExclusion Criteria:\n\n* Youth not between ages 5 and 14 at the start of the intervention\n* Parent not enrolled in the Every Dollar Counts program","10 Years","18 Years",{"count":57,"type":22},500,"INTERVENTIONAL",[60],"NA","Growing up in a lower-income family robustly predicts worse mental health in adolescence and early adulthood. How does variability in family income \"get under the skin\" of the developing child and via what mechanisms does it increase risk for mental illness? Moreover, could supplements to family income at critical developmental periods help to prevent later youth mental illness? To address these questions, we leverage an innovative existing double blind randomized controlled trial of 3-years of substantial income supplements to parents.\n\nBy experimentally studying the impacts of these income supplements on families and subsequent youth development, we can examine causal pathways from family income to risk for mental illness via family stress and neuroimmune mechanisms in ways never done before. Moreover, by measuring the longer-term impact of 3 years of income supplements to parents on their child's neuroimmune signaling and risk for mental illness, we can examine the policy implications for child development of unconditional cash transfers to parents and identify how and for whom these supplements help. We will test these basic and translational questions in a sample of 1,200 youth with lower-income parents randomly assigned to receive either a substantial monthly income supplement or a minimal monthly supplement for 3 years, starting when youth were between age 5 - 14 years old. We will follow up with youth and their parent 1 - 2 and 3 - 4 years after the intervention and examine whether income supplements predict better youth mental health during adolescence, as well as whether factors like child age and neighborhood quality modulate intervention effects. Additionally, we explore family stress mechanisms through which the intervention may impact child mental health. Finally, we will measure peripheral inflammation (inflammatory biomarkers and classical monocytes) and use MRI to assess threat, reward, and regulatory neural activity and connectivity among 500 of these youth. Our central hypothesis is that income supplements will decrease family and youth stress and improve parenting, which will improve neuroimmune signaling and decrease risk for psychopathology. Moreover, these effects will remain years after termination of the transfers and be strongest among families who received the intervention earlier in the child's life. This research will provide timely, relevant public health knowledge that will help policy makers understand the longer-term brain, immune, and mental health impacts of cash transfers to parents, while also advancing the science of the sociocontextual and neuroimmune pathways through which variability in family income impacts risk for psychopathology.",[63,27,64,65,66,67],"Psychopathology","Anxiety Disorders","Mental Disorders","Inflamation","Poverty",[69,70,71,72,73,67,27,63,74],"Depression","Anxiety","Internalizing Disorders","Externalizing Disorders","Inflammation","Stress","2026-06-08",{"date":77,"type":39},"2026-06-11",{"date":79,"type":39},"2026-04-04",{"date":81,"type":22},"2029-08-31",{"name":83,"class":46},"Northwestern University",1,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":4,"studyType":58,"phases":96,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":109,"locationsCount":84},"100590141","examining-whether-project-support-works-100590141","NCT06963554","Examining Whether Project Support Works","Randomized Controlled Trial of Project Support","Inclusion Criteria:\n\n* Family is seeking trauma-focused services for their child;\n* Child is between 6 - 13 years old;\n* Caregiver agreed to be contacted for volunteer research opportunities;\n* Caregiver and child can communicate in English or Spanish;\n* Child has been living with caregiver for the last 6 months or longer;\n* Family is able to participate in services delivered via telehealth.\n\nExclusion Criteria:\n\n* Child or caregiver has a diagnosis that would impair their ability to participate in or benefit from services (e.g., traumatic brain injury, developmental disability, psychosis);\n* Child is in Foster Care or Department of Social Services custody;\n* The caregiver is unwilling or unable to give informed consent and\u002For the child is unwilling and unable to give assent.","6 Years","13 Years",{"count":95,"type":22},100,[60],"This study will involve a randomized, controlled trial with two parallel groups, Project Support and a treatment as usual control group. Families with a child on the waitlist for trauma-focused services will be invited to participate. Participation involves completing a baseline assessment of family functioning and trauma characteristics. Participants will then be randomized to either Project Support or the treatment as usual control group. All participants will be invited to complete the post-test assessment 4-6 weeks after the baseline assessment, prior to beginning trauma-focused services.",[99,100,27],"Parent-Child Relations","Parenting Self Efficacy",[102,103],"Child trauma","Non-offending caregiver",{"date":105,"type":39},"2026-06-09",{"date":107,"type":39},"2025-11-04",{"date":43,"type":22},{"name":110,"class":46},"Medical University of South Carolina",{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":119,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":58,"phases":122,"briefSummary":123,"conditions":124,"keywords":132,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":84},"100633658","the-new-beginnings-podcast-brief-audio-intervention-for-parents-from-divorced-and-separated-families-100633658","NCT07529548","The New Beginnings Podcast: Brief Audio Intervention for Parents From Divorced and Separated Families","\"The New Beginnings Podcast: A Small-scale Randomized Controlled Trial of a Parenting Podcast to Improve Outcomes for Children From Divorced Families\"","NBP-P","Inclusion Criteria:\n\nFor Parents, eligibility criteria are:\n\n1. divorced, separated, separated but never married, or divorcing\u002Fseparating within the last two years;\n2. one or more children between the ages of 8-18 years old;\n3. have in-person contact with their child(ren) at least three hours per week or have at least one overnight visit every other week;\n4. have access to a smartphone with internet that can play audio files;\n5. English speaking.\n\nFor children, eligibility criteria are:\n\n1. have a parent who is participating in the trial;\n2. be between the ages of 8-18 and\n3. have access to a computer to complete assessments. If a parent has more than one child aged 8-18 interested in participating, we will randomly select one child to ensure independence of responses.\n\nExclusion Criteria:\n\n\\-","8 Years",{"count":121,"type":22},80,[60],"The goal of this study is to learn if the New Beginnings Podcast can help children whose parents are going through a divorce or separation. The podcast shares parenting strategies that have been shown to help in past in-person and online programs. This study will also look at how easy it is for parents to use the podcast and how helpful they find it.\n\nThe main questions it aims to answer are:\n\n1. Do parents find the podcast easy to use, helpful, and relevant?\n2. Does listening to the podcast improve children's mental health?\n3. Does the podcast help parents build stronger relationships with their children and reduce conflict between parents?\n\nResearchers will compare families who use the podcast to families on a waitlist to see if the podcast makes a difference.\n\nParticipants will:\n\n1. Listen to podcast episodes over the course of the study\n2. Answer questions about their experiences with the podcast\n3. Complete surveys about their child's well-being, their parenting, and family relationships\n\nThis study will include 80 parents and their children.",[125,126,127,128,129,130,131,27],"Parent Child Relationship","Parenting Intervention","Parenting Behaviour","Interparental Conflict","Feasibility Study","Acceptability","Appropriateness",[133,134,135,136,137,138,126,139,27],"Parenting","Divorce","Separation","Separated and Divorced Parents","Podcast","Prevention","New Beginnings Program","2026-04-10",{"date":142,"type":39},"2026-04-14",{"date":144,"type":39},"2025-08-15",{"date":146,"type":22},"2026-12",{"name":148,"class":46},"Charla Aubrey Rhodes",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":158,"minAge":55,"maxAge":4,"enrollmentInfo":159,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":161,"conditions":162,"keywords":175,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":84},"100607934","early-life-malnutrition-environmental-enteric-dysfunction-and-microbiome-trajectories-100607934","NCT07195006","Early Life Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories","Early Life Diarrhoea Episode(s), Malnutrition, Environmental Enteric Dysfunction and Microbiome Trajectories From Birth Until 3 Years of Life ; The University of Zimbabwe Birth Cohort Study-2 (UZBCS-2)","UZBCS-2","Inclusion Criteria for Cases:\n\n* MUAC ≤23 cm in pregnancy\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to be staying in the study area for the next 3 years\n* Willing to participate and comply with all study requirements and procedures.\n\nAny pregnant woman meeting the above eligible criteria regardless of HIV status who meet the above inclusion criteria will be invited to participate in the study\n\nInclusion criteria for Controls\n\n* Age, HIV status, gestational age at enrolment, and area residence matched normo-nourished peers with MUAC ≥25 - ≤35 cm\n* Haemoglobin level of ≥11g\u002FdL\n* ≥18 years' old\n* At least 20 weeks' gestational age\n* Height ≥150 cm\n* Planning to stay in the study area for the next 3 years\n\nExclusion Criteria\n\n* Acute or chronic conditions in mothers interfering with the study according to the judgment of the investigator (HIV infection is not an exclusion criterion)\n* Presence of severe mental health disorders interfering with study procedures according to the judgment of the investigator.",true,"FEMALE",{"count":160,"type":22},368,"Malnutrition in women of reproductive age remains a public health concern in Sub-Saharan Africa (SSA). Malnutrition during pregnancy affects foetal growth with a tendency of the exposed infants to also develop it. The interaction of the mother with the infant shapes the seeding and the trajectory of the infant intestinal microbiota which is crucial for development of a healthy immune system Malnutrition has been associated with intestinal inflammation, intestinal leakage and reduced calorie absorption. Early life malnutrition and environmental enteric dysfunction (EED) immunopathology remains poorly described in the context of mother-infant dyads. This is essential as malnutrition, poor water, sanitation and hygiene (WASH), including the presence of infectious diseases limit the developmental potential of the exposed infants in SSA, including Zimbabwe. In addition, maternal stress and poor mental health may also affect standard hygiene practices, including how a mother cares for her baby, potentially aggravating EED and the risk of the infant being malnourished.\n\nPrimary outcomes\n\n1. Infant malnutrition and recovery.\n2. Gut dysfunction (gut inflammation, leaky gut, malabsorption, dysbiosis)\n3. Diarrhea episodes, defined as any episode of acute diarrhoea (≥3 passages of loose stool within 24 hours as reported by the mother) occurring before the next study visit.\n\nDefinition of malnutrition outcomes to be assessed in babies born to malnourished women, is a mid- upper arm circumference (MUAC) \\\u003C23cm;\n\n* MUAC for age: Malnourished defined as those below -2 standard (SD) of the World Health Organisation (WHO) reference\n* Weight-for-age: Underweight defined as those below -2SD WHO reference\n* Weight-for-height: Wasted defined as those below -2SD WHO reference\n* Height-for-age: Stunted defined as those below -2SD WHO reference\n* Z-scores (as they are i.e. a continuous variable, taking age of infants into account)\n* A composite variable, any of malnourished, underweight, wasted or stunted.",[163,164,165,166,167,168,169,170,27,171,172,173,174],"Malnutrition Pregnancy","Malnutrition in Children","Malnutrition (Calorie)","Environmental Enteric Dysfunction","Gut Dysbiosis","Gut Permeability, Gut Inflammation","Diarrhea Infectious","Maternal Stress","Natural Killer Cell Mediated Immunity","Mycotoxin Biomonitoring","Environmental Exposures","Cell-Mediated Immune Deficiency",[176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192],"diarrhoeal episodes","short chain fatty acids receptor agonists","intestinal inflammation, leakage and calory extraction","toxins in drinking water and food","macro- and micronutrient composition of breast milk","human anti-Gal antibodies","mitochondria health and nutrient uptake","endothelial dysfunction and oxidative stress","hormonal mediated molecular signalling mechanisms","interaction of epigenetics & socioeconomic factors","microbiota, pathobionts and oral microbiota","metagenomics","undernutrition and intestinal infections","infant mortality, morbidity within 1st 1000 days of life","low mid upper arm circumference","sleep adequacy in maternal mental health","chronic inflammation","2025-09-18",{"date":195,"type":39},"2025-09-26",{"date":197,"type":39},"2025-01-27",{"date":199,"type":22},"2032-12-31",{"name":201,"class":46},"University of Zimbabwe",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":17,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":4,"studyType":58,"phases":212,"briefSummary":213,"conditions":214,"keywords":217,"overallStatus":221,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":84},"100605326","a-program-evaluation-of-the-brief-family-therapy-program-in-the-york-university-psychology-clinic-100605326","NCT07161063","A Program Evaluation of the Brief Family Therapy Program in the York University Psychology Clinic","Inclusion Criteria:\n\n* Both primary caregivers are over age 18 years\n* Families living in Ontario, Canada\n* Primary caregivers endorses caring for a child between 2 to 9 years old with a mental health challenge (e.g., anxiety, low mood, behavioural challenges) or mild\u002Fmoderate levels of family distress\n* Both caregivers and child agree to participate\n* Family must have access to a screen (phone, tablet, computer) and internet for virtual services and recording.\n\nExclusion Criteria:\n\n\\- Families seeking care for child who is at imminent risk of harm to self or others","2 Years","9 Years",{"count":211,"type":22},30,[60],"Background. Children are vulnerable to mental health challenges during development. Given that youth are reliant on their parents for support, understanding the child's symptoms within the family context is critical for promoting positive change. This proposal focuses on \"systemic therapy\", or family-based therapy, which seeks to enhance children's mental health by improving the relationships and communication between family members (1). Most family-based therapies for treating child mental health problems are intense in duration and frequency (2), which is a barrier to access for many families. Shorter-term family therapies or what will be referred to hereafter as brief family-based therapies are effective in treating a variety of child symptoms, while also minimizing participant burden and therapy dropout (3). One type of brief family-based therapy model is the Lausanne Family Play - Brief (LFP-B), a three-session service that utilizes a play-based family observational assessment with video feedback to draw attention to and catalyze change in challenging family interactions. The LFP has been widely researched as a clinical assessment tool and has been implemented as a brief family-based therapy program (4). The current project represents the implementation and evaluation of the program in the York University Psychology Clinic (YUPC), which services children, adults, couples, and families in the Greater Toronto Area (and Ontario, broadly). The current study will be the first to evaluate the implementation, acceptability, and effectiveness of the LFP-B as a clinic service. Objectives. The aim of this project is to evaluate the LFP-B as a brief family-based clinical service offered in the YUPC. The first objective is to explore program acceptability for both clients and therapists. The investigators are interested in whether clients and therapists are satisfied with this clinical service and its processes. The second objective is to assess program effectiveness, specifically whether coparenting, family functioning, and child mental health problems improve across the course of the program and in the months following. Importance. Brief therapies with a systemic lens can increase cost-effectiveness, accessibility, and treatment retention. They also have potential to fill an apparent gap in service needs as up to three-quarters of youth with psychological concerns never receive treatment (5). Thus, brief services can provide more timely access to mental health care in Canada which have potential for reducing wait times, preventing further deterioration in mental health, and avoiding more intensive and expensive higher levels of care (e.g., acute inpatient mental health services; (6)). The LFP-B has potential to be widely used as a brief family-based therapy program with Canadian families to support child and family functioning in a timely and non-intensive manner.",[215,27,216],"Family Relationships","Coparenting",[218,219,216,129,220],"Brief Family Therapy","Family Systems","Implementation Study","NOT_YET_RECRUITING","2025-09-05",{"date":224,"type":39},"2025-09-12",{"date":226,"type":22},"2025-09",{"date":228,"type":22},"2029-08",{"name":230,"class":46},"York University",{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":17,"minAge":239,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":58,"phases":243,"briefSummary":244,"conditions":245,"keywords":248,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":255,"lastUpdatePostDateStruct":256,"startDateStruct":258,"completionDateStruct":260,"leadSponsor":262,"locationsCount":84},"100577211","wellbeing-and-resilience-among-1-3-years-old-children-of-mothers-with-complex-mental-health-problems-a-pragmatic-clinical-trial-of-online-vipp-sd-vs-care-as-usual-100577211","NCT06795347","Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial of Online VIPP-SD Vs. Care As Usual","Wellbeing and Resilience Among 1-3 Years Old Children of Mothers with Complex Mental Health Problems: a Pragmatic Clinical Trial","WellCom","Inclusion Criteria:\n\n* child age 1 year, 0 months until 3 years, 0 months\n* living with their mother in the Region of Southern Denmark\n* mother has a mental disorder (Schizophrenia ICD-10: F20-29, Bipolar disorder ICD-10: F30-31, Moderate to severe depression ICD-10: F32-33 or Emotionally unstable personality disorder F60.3) verified in the Danish National Hospital Register-Psyk\u002Fthe Danish Psychiatric Central Research Register or by a clinician at the mental health services via the patient record\n* mother has had at least one in- or outpatient contact with mental health services within 12 months before birth of the child or during the child's lifetime verified in the Danish National Hospital Register or by a clinician at the mental health services via the patient record\n\nExclusion Criteria:\n\n* current in-patient status of the mother\n* current substance or alcohol abuse of the mother\n* mother has insufficient knowledge of Danish (interpreter required)\n* repeated intrauterine exposure to euphoriants or large amounts of alcohol (≥5 units per time or ≥7units per week) of the child\n* known syndrome or autism spectrum disorder of the child\n* mother or child has sensory impairment\n* sibling participating in study\n* family participating in another closely related research trial receiving an individualized video-feedback intervention\n* participating in active court proceedings","1 Year","3 Years",{"count":242,"type":22},120,[60],"Children of parents with severe mental disorders have an increased risk of mental disorders themselves, with more than half of this population diagnosed with a mental health condition during their life time. Already during early childhood, the risk of a mental health diagnosis is elevated by a factor 2-5, compared to children of parents without severe mental disorders. This highlights the need for preventive interventions.\n\nMental health during early childhood is inextricably linked with early parent-child interaction. Sensitive parenting plays a crucial role in the socio-emotional development of the child, and severe parental mental disorders may affect the quality of parent-child interaction.\n\nTherefore, we will test the effect of an intervention promoting sensitive parenting on mental health outcomes of 1-3 years old children of parents with severe mental disorders. The intervention will be tested in a randomized clinical trial comparing the intervention \"Video-feedback Intervention to Promote Positive Parenting and Sensitive Discipline\" (VIPP-SD) delivered online to Care As Usual. Our hypothesis is, that children in the Intervention Group will display lower levels of behavioral problems and increased attachment security compared to children in the Care As Usual Group.\n\nThe study will be conducted in the department of Child and Adolescent Psychiatry, Mental Health Services in the Region of Southern Denmark. Participants are mothers with a diagnosis of schizophrenia, bipolar disorder, emotionally unstable personality disorder or moderate to severe depression living in the Region of Southern Denmark with their 1-3 years old child, and the father\u002Fcohabitating partner. Participants will be recruited via psychiatric outpatient clinics in the region or on the basis of information from health registers.\n\nThe primary outcome of the study is child behavioral problems. Secondary child outcomes are attachment security and mental health. Parental outcomes are parental stress and quality of life. Child cognition, parental psychiatric symptoms, childhood trauma, sensitivity, parental reflective functioning and service use data are also assessed in the study. Data are collected at baseline as well as 5 and 11 months after randomization. All participants will have the opportunity to receive feedback on their child's cognitive functioning and mental health status at baseline and at the end of the study.\n\nAfter baseline assessments, participants will be randomized to either intervention or the control group.\n\nThe intervention, VIPP-SD, is delivered online apart from the first session, which is conducted as a home visit. VIPP-SD is based on attachment and social learning theory. It is manualized and consists of 12 individual sessions alternating between video-recording of mother and child in pre-defined everyday situations and review\u002Fdiscussion of the video recordings with the mother\u002Fparents. Focus of the intervention is the childs signals and needs, and how to promote healthy socio-emotional development of the child. VIPP-SD will be carried out by health care professionals trained and certified in VIPP-SD.\n\nParticipants who are randomized to the control condition, Care As Usual, will continue as they did before enrollment to the study. Care As Usual is defined as any kind of help and support related to the social-emotional development and mental wellbeing of the child in the municipality or mental health services.",[27,246,247],"Behavioral Symptoms","Child of Impaired Parents",[249,250,138,251,252,253,254],"Parental psychiatric disorder","Child mental disorders","Socio-emotional development","Child behavioral problems","Child externalizing problems","Parental sensitivity","2025-01-25",{"date":257,"type":39},"2025-01-28",{"date":259,"type":22},"2025-02",{"date":261,"type":22},"2028-01-31",{"name":263,"class":46},"University of Southern Denmark",{"id":265,"slug":266,"hasResults":11,"nctId":267,"briefTitle":268,"officialTitle":269,"acronym":270,"eligibilityCriteria":271,"healthyVolunteers":11,"sex":17,"minAge":55,"maxAge":272,"enrollmentInfo":273,"targetDuration":4,"studyType":58,"phases":275,"briefSummary":276,"conditions":277,"keywords":280,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":290,"lastUpdatePostDateStruct":291,"startDateStruct":293,"completionDateStruct":294,"leadSponsor":296,"locationsCount":298},"100519702","building-emotional-awareness-and-mental-health-in-parenting-beam-100519702","NCT06046989","Building Emotional Awareness and Mental Health in Parenting (BEAM)","BEAM: Building Emotional Awareness and Mental Health in Parenting. An App-based Intervention to Improve Parental Mental Health and Support Children's Brain Development.","BEAM","Inclusion Criteria:\n\n* Parent is 18 years of age or older\n* Must have a child who is 3-4 years old\n* Must show clinically elevated symptoms of depression, anxiety, \\&\u002For anger\n* Living in the Vancouver or Calgary area\n* Parent is comfortable understanding, speaking, and reading English\n\nExclusion Criteria:\n\n* Parent is under the age of 18\n* Does not show clinically elevated symptoms of depression, anxiety, and\u002For anger\n* History of attempted suicide or self-harm in the past 6 months\n* Does not live in the Vancouver or Calgary area\n* Child has serious genetic, neurological, or neurodevelopmental disorders that impact cognitive function or brain structure\u002Ffunction (e.g., Down Syndrome, epilepsy, etc.), or if they have contra-indications to MRI scanning (i.e., metal implants)","65 Years",{"count":274,"type":22},240,[60],"Postpartum (child age 0-5 years) mental health problems are common, with prevalence rates ranging from 15-20% for depression, 3-43% for anxiety, and approximately 30% for anger. Depression, anxiety, and anger often occur comorbidly. If left untreated, these disorders can be long-lasting and lead to child behaviour problems, brain changes, and risk for later mental illness. We developed an app-based treatment for parental mental illness: Building Emotional Awareness and Mental Health in Parenting (BEAM). The BEAM program includes mental health and parenting videos, peer coaching, as well as a forum and drop-in Zoom sessions where parents can connect with each other to receive and provide social support. The program is supported by peer coaches (parents with lived experience of recovery from mental illness and who may have received emotion-focused parenting support) and supervised by clinically-trained staff. Peer coaches check-in with parents weekly to support their progress. Our study will see the BEAM app's effect on parent mental health, parenting stress, child behaviour, and child brain structure and function. 240 parents with high depression, anxiety, and\u002For anger symptoms will be recruited, with half forming the treatment-as-usual group.",[278,133,27,279],"Parent Mental Health","Child Development",[281,282,283,284,285,286,287,288,289],"anxiety","depression","anger","brain imaging","parenting","behavioural neuroscience","child development","child mental health","eHealth","2024-03-25",{"date":292,"type":39},"2024-03-27",{"date":290,"type":39},{"date":295,"type":22},"2026-08",{"name":297,"class":46},"University of Calgary",2]