[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulnerable-families\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulnerable-families":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,51,78],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":5},"100633670","evaluation-of-a-multicomponent-early-intervention-for-childhood-obesity-prevention-in-vulnerable-families-100633670",false,"NCT07529704","Evaluation of a Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families","Evaluation of a Tailored Multicomponent Early Intervention for Childhood Obesity Prevention in Vulnerable Families (Bambú Project): Randomized Controlled Trial With a Hybrid Type 1 Effectiveness-implementation Design","Bambú","Inclusion Criteria:\n\n* Mothers and\u002For fathers aged 18 years or older.\n* Primary caregivers of a healthy child aged 6 months to 3 years, born at term (≥37 weeks of gestation).\n* At least one parent with overweight or obesity (as defined by BMI criteria).\n* Families in a situation of vulnerability, defined as meeting ≥2 of the following criteria: (1) Low educational level of at least one parent (≤ lower secondary education or equivalent); (2) Precarious employment situation during the past year, (3) Perceived financial difficulties during the past year; (4) Insecure or unstable housing conditions; (5) Single-parent family or prolonged absence of one of the primary caregivers; (6) Recent immigration (≤10 years) without a stable support network or with language barriers.\n\nExclusion Criteria:\n\n* Parents of a child aged 6 months to 3 years with low birth weight (\\\u003C2500 g)\n* Parents of a child aged 6 months to 3 years from a multiple birth (e.g., twins, triplets)\n* Parents\u002Fcaregivers of a child aged 6 months to 3 years with congenital conditions, chronic diseases, or severe disabilities that may affect feeding, growth, or participation in the study\n* Parents or caregivers with severe physical or mental health conditions that would limit their ability to participate in the intervention or assessments\n* Families planning to move out of the study area during the study period",true,"ALL",{"count":20,"type":21},526,"ESTIMATED","INTERVENTIONAL",[24],"NA","Childhood obesity is a public health concern. Evidence-based, multicomponent, parenting interventions targeting early childhood and adapted to families' socioeconomic context are needed to prevent childhood obesity.\n\nThis study aims to evaluate the effectiveness of an early intervention in primary care for the prevention of childhood obesity, targeting vulnerable families where the mother and\u002For the father has overweight or obesity.\n\nMore specifically, the primary aim of this study is to evaluate the effectiveness the intervention to maintain a healthy weight in children aged 6 months to 3 years, measured by the BMI-for-age z-score at baseline, 6, 12, and 18 months, compared to usual care.\n\nThe study also aims to evaluate the effectiveness of the intervention, compared to usual care, for: promoting responsive feeding, improving dietary intake, improving parents' and children's physical activity levels, improving parents' eating styles, and improving children's sleep.\n\nFinally, the study aims to determine the feasibility of implementing the intervention, and to identify factors influencing change and contextual factors in the implementation process.\n\nA pragmatic cluster randomized controlled trial will be conducted. Approximately 526 families (parent-child family dyads) will be recruited, belonging to 76 primary care centers. Primary care centers will be randomly assigned to either an intervention or control group.\n\nThe intervention has been previously co-designed with families and healthcare professionals, and consists of five weekly sessions and 4 monthly sessions, lasting 2 hours each. It will be delivered by previously trained healthcare professionals or by members of the research team, depending on the preferences and availability of the primary care center professionals. Approximately 38 intervention face-to-face groups will be conducted, one in each primary care center allocated to the intervention group.\n\nThe study will be conducted in Catalonia, Andalusia and the Balearic Islands (Spain).\n\nEffectiveness outcomes include child body mass index (BMI) z-score, parent feeding practices (measured with the Feeding Practices and Structure Questionnaire), child dietary intake (measured with the multiple-pass 24-hour recall), parents' eating behaviours (measured with the Dutch Eating Behavior Questionnaire), child movement (measured with the Movement Behavior Questionnaire), parents' movement behaviours (measured with the Brief Physical Activity Assessment Tool), and child sleep (measured with selected items from the Brief Infant Sleep Questionnaire).\n\nImplementation and feasibility outcomes will be assessed through interviews during and at the end of the intervention, and through attendance sheets and a final satisfaction questionnaire.\n\nThis study will provide pioneering insights into the implementation and effectiveness of this intervention within the public healthcare system in Spain. This will allow the potential implementation in the future at a larger scale.",[27,28,29,30],"Obesity & Overweight","Vulnerable Families","Children","Families With Infants",[32,33,34,35,36,37,38],"Pediatric obesity","Prevention","Vulnerable populations","Randomized controlled trial","Primary health care","Early intervention","Parenting interventions","RECRUITING","2026-04-07",{"date":42,"type":43},"2026-04-14","ACTUAL",{"date":45,"type":43},"2026-03-02",{"date":47,"type":21},"2028-06",{"name":49,"class":50},"Helena Vall Roqué","OTHER",{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":17,"sex":18,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":62,"briefSummary":63,"conditions":64,"keywords":65,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":68,"lastUpdatePostDateStruct":69,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":77},"100572363","stronger-families-through-art-therapy-a-mixed-methods-programme-evaluation-study-100572363","NCT06732297","Stronger Families Through Art Therapy: A Mixed Methods Programme Evaluation Study","SFAT","Inclusion Criteria (family participant):\n\n* the caregiver (including parents, grandparents, family members or foster parents who perform the main caretaking responsibilities of the children taking part in SFAT) of a young child who can communicate in English and provide informed consent\n* the child is aged 7-14 years and can communicate in English\n* the family have one or more of the following identified challenges: (1) caregiver stress such as finances, household management, work and childcare arrangements, (2) caregiver struggles to find time for self-care and quality time with children, (3) caregiver has minimal understanding of the psychological and emotional needs of their children, (4) children face difficulties with emotional regulation and anger management\n* caregivers and children are from low-income families who receive financial assistance under the CHAS Blue card, ComCare financial assistance, and\u002For the MOE Financial Assistance Scheme\n\nInclusion criteria (art therapist participant) registered art therapist based in the Red Pencil (Singapore) who are in charge of delivering the SFAT programme\n\nInclusion criteria (community staff participant)\n\n\\- community staff who provides assistance to the implementation of the SFAT programme\n\nExclusion Criteria:\n\n* individuals who are suffering from depression or other major mental health conditions that would render their participation highly disruptive to others in a group setting, and\u002For cannot provide informed consent. Families will also be excluded if they are currently unstable (i.e. circumstances related to abuse\u002Fneglect), and\u002For have high risk of suicidal and self-harm behaviours. In the cases that individuals referred to the programme are not eligible, the partner organisations will assess their needs and refer them to programmes based on these needs.\n* participant is unable to provide informed consent","7 Years","99 Years",{"count":61,"type":21},96,[24],"The current research aims to evaluate the effectiveness and feasibility of the Strong Families Through Art Therapy (SFAT) programme, which was developed to improve the parent-child relationship in vulnerable families. The main questions it aims to answer are:\n\n1. Is the programme effective in enhancing quality of life and family resilience among parents?\n2. Is the programme effective in enhancing quality of life among children?\n3. Is the programme feasible and acceptable for large scale implementation in Singapore?\n\nResearchers will compare the status of family participants (caregivers and children) before and after they take the programme and compare family participants who take the programme with family participants who have not yet taken the programme to see if the programme is effective in benefiting the participants. Researchers will also invite family participants to discuss about the programme.\n\nFamily participants will\n\n1. Take the 10-week SFAT programme\n2. Complete assessment survey for 3 times\n3. Attend a focus group discussion (optional)\n\nTo assess the programme feasibility, researchers will additional invite art therapist participants to evaluate the programme and invite community staff participants to discuss about the programme implementation.\n\nArt therapist participants will complete programme and session evaluation reports.\n\nCommunity staff participants will attend a focus group discussion.",[28],[66,67],"Vulnerable families","art therapy","2026-02-20",{"date":70,"type":43},"2026-02-24",{"date":72,"type":43},"2025-02-22",{"date":74,"type":21},"2026-12-31",{"name":76,"class":50},"Nanyang Technological University",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":18,"minAge":86,"maxAge":4,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":98,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":5},"100605436","attach-in-denmark-a-feasibility-randomized-controlled-trial-100605436","NCT07162493","ATTACH in Denmark: A Feasibility Randomized Controlled Trial","Attachment and Child Health (ATTACH) Added to Treatment As Usual Versus Treatment As Usual Alone for Parents With Psychosocial Problems: A Feasibility Randomized Controlled Trial","AiD","Inclusion criteria\n\n* Child aged 0 - 5.7 years at enrollment.\n* Speaks Danish or English sufficiently to take part in assessments and intervention without an interpreter.\n* Both parents provide consent in case of shared child custody. Parents experience psycho-social problems that have resulted in referral to the family treatment center on the basis of legislation from the Danish Child Act (\"Barnets Lov\"), under the following Sections defining support needs: Section 29: Family counselling: Includes open access to family counselling as an early preventive effort. In this context, the counselling may involve referring the family to other departments within the municipality or to other relevant authorities that can provide the appropriate guidance and support. Section 30: Early preventive intervention: Includes a variety of approaches, such as consultancy services and participation in network or discussion groups to address and prevent challenges faced by the family at an early stage. Section 32: Supportive interventions: May be initiated on the basis of a preliminary assessment or a child welfare investigation pursuant to Sections 19 and 20 of the Child Act, or concurrently with the completion of such an assessment or investigation. Support may include practical, pedagogical, or other types of support in the home; appointment of a permanent contact person for the entire family; family therapy or individual treatment for the child or young person; family placement involving residential care in a foster family, an approved child and youth residential facility, or a housing facility; supportive placement in a foster family or in an approved child and youth residential facility; other forms of assistance aimed at providing counseling, treatment, and practical and pedagogical support.\n* Parents who have their child in out-of-home placement \u002Ffoster care (with or without consent).\n* Parental psychosocial problems such as (but are not limited to) mental health problems, cognitive difficulties, substance abuse, poverty, social isolation, adverse childhood experiences, functional or somatic disorders, criminal involvement, domestic violence, having a child with emotional regulation difficulties, having a child with developmental problems, having a child with functional or somatic problems, having a child with internalizing or externalizing problems.\n\nExclusion Criteria:\n\n* Child is older than 5.7 years at enrollment.\n* Parent does not speak Danish or English sufficiently to take part in assessments and intervention without an interpreter.\n* Consent cannot be obtained from both parents in case of shared child custody.\n* The parent is known to move to a different municipality within 5 months from randomization.","18 Years",{"count":88,"type":21},52,[24],"The goal of this feasibility randomized controlled pilot trial is to learn whether the trial can be done as planned, and to investigate if the 10-session parenting program \"ATTACH(TM) increases mentalizing skills (the ability to reflect on thoughts and feelings) in parents of children between 0-5 years of age, who are receiving support for psychosocial problems in their municipal family treatment center.\n\nThe main questions the trial aims to answer are:\n\n* How many eligible parents agree to participate in the random allocation to treatment?\n* How many parents allocated to receive \"ATTACH(TM) will have completed the program 5 months after allocation (at least 7 out of 10 sessions)?\n* How many parents complete the data collection 5 months after allocation on the primary exploratory clinical outcome, i.e., parental mentalizing skills?\n* Do parents who received the ATTACH(TM) program show more increase in their mentalizing skills, compared to parents, who did not receive treatment with ATTACH(TM)?\n\nResearchers will compare ATTACH, added to Treatment as Usual, with Treatment as Usual without ATTACH in three municipal family treatment centers located in the Capital Region of Denmark.\n\nParticipants will:\n\n1. Take part in baseline data collection with a survey, video observation of parent-child interaction, and an interview assessing mentalizing skills.\n2. Be randomly allocated to receive treatment in their local family center with or without ATTACH.\n3. Take part in data collection 5 months after being allocated to either group, as well as participate in an interview about their experiences with the treatment they received.\n4. After one year, the research group will follow up on the current treatment\u002Fsupport needs of the families, who were allocated to either group.",[92,93,94,95,96,28,97],"Mentalization","Recruitment of Participants","Adherence, Treatment","Drop Out","Parenting Intervention","Feasibility Studies",[99,100,101,102],"parenting","mentalizing","intervention","feasibility","2025-09-17",{"date":105,"type":43},"2025-09-23",{"date":107,"type":43},"2025-09-01",{"date":109,"type":21},"2027-12-31",{"name":111,"class":50},"Johanne Smith-Nielsen"]