[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576648":3},{"organization":4,"armGroups":7,"interventions":45,"overallOfficials":64,"centralContacts":68,"locations":73,"responsibleParty":101,"collaborators":103,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":51,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":130,"overallStatus":76,"whyStopped":51,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"University of Chicago","OTHER",[8,16,20,24,28,32,36,40],{"label":9,"type":10,"description":11,"interventionNames":12},"Family Strengthening, Mental Health, Economic Empowerment","EXPERIMENTAL","Group will receive: 1) Usual Care, 2) Family Strengthening, 3) Trauma-focused Mental Health Services, and 4) Economic Empowerment Interventions",[13,14,15],"Behavioral: Family Strengthening","Behavioral: Mental Health Screening, Referral and Connection to Services","Other: Economic Empowerment",{"label":17,"type":10,"description":18,"interventionNames":19},"Family Strengthening, Mental Health","Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Trauma-focused Mental Health Services",[13,14],{"label":21,"type":10,"description":22,"interventionNames":23},"Family Strengthening, Economic Empowerment","Group will receive: 1) Usual Care, 2) Family Strengthening, and 3) Economic Empowerment Interventions",[13,15],{"label":25,"type":10,"description":26,"interventionNames":27},"Family Strengthening Only","Group will receive: 1) Usual Care and 2) Family Strengthening Interventions",[13],{"label":29,"type":10,"description":30,"interventionNames":31},"Mental Health, Economic Empowerment","Group will receive: 1) Usual Care, 2) Trauma-focused Mental Health Services, and 3) Economic Empowerment Interventions",[14,15],{"label":33,"type":10,"description":34,"interventionNames":35},"Mental Health Only","Group will receive: 1) Usual Care and 2) Trauma-focused Mental Health Services",[14],{"label":37,"type":10,"description":38,"interventionNames":39},"Economic Empowerment Only","Group will receive: 1) Usual Care and 2) Economic Empowerment Interventions",[15],{"label":41,"type":10,"description":42,"interventionNames":43},"Usual Care Only","Group will receive: Usual Care Intervention only",[44],"Behavioral: Usual Care",[46,52,56,60],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"BEHAVIORAL","Usual Care","All participants receive the usual care via standard mental health services offered by the NMHC to the public free of charge. Participants will have access to these public services regardless of whether or not they choose to participate in this study. If they refuse to participate in the research study, they will still have access to usual care.",[41],null,{"type":47,"name":53,"description":54,"armGroupLabels":55,"otherNames":51},"Family Strengthening","Families will engage in 12 weekly (1-1.5 hours) of family strengthening sessions, led by trained facilitators from the Research and Education Center. Groups will be composed of approximately 5 caregiver-child dyads. Sessions are designed to improve family functioning, strengthen child-parent relationships, enhance parenting strategies, and prevent emotional and behavioral problems among at-risk children.",[25,21,17,9],{"type":47,"name":57,"description":58,"armGroupLabels":59,"otherNames":51},"Mental Health Screening, Referral and Connection to Services","Children will receive 12 sessions of individual mental health services. Clinicians are trained in the Attachment, Regulation, and Competency (ARC) framework. Services include a clinical assessment performed by a psychiatrist, development of an individual care plan, and corresponding mental health services, informed by ARC.",[17,9,33,29],{"type":6,"name":61,"description":62,"armGroupLabels":63,"otherNames":51},"Economic Empowerment","Child Development Accounts (CDAs) will be opened to facilitate family savings. The project will provide $50 as seed money to open a savings account in the child's name. Savings of up to $20 per month will be matched with study funds at a rate of 2:1 and placed in the CDA account. Caregivers and children will also engage in 12 weekly (1-1.5 hours) of financial education sessions, led by facilitators from the Research and Education Center.",[37,21,9,29],[65],{"name":66,"affiliation":5,"role":67},"Leyla Ismayilova, PhD","PRINCIPAL_INVESTIGATOR",[69],{"name":66,"role":70,"phone":71,"phoneExt":51,"email":72},"CONTACT","773-834-0401","leyla@uchicago.edu",[74,92],{"facility":75,"status":76,"city":77,"state":78,"zip":51,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"National Mental Health Centre under the Ministry of Health","RECRUITING","Baku","Azerbaijan","AZ",{"type":81,"coordinates":82},"Point",[83,84],49.89201,40.37767,{"lat":84,"lon":83},[87,90],{"name":88,"role":70,"phone":51,"phoneExt":51,"email":89},"Narmin Guliyeva, MD","narminguliyevas@gmail.com",{"name":91,"role":67,"phone":51,"phoneExt":51,"email":51},"Fuad Ismayilov, MD",{"facility":93,"status":76,"city":77,"state":78,"zip":51,"country":78,"countryCode":79,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"Research and Education Center",{"type":81,"coordinates":95},[83,84],{"lat":84,"lon":83},[98],{"name":99,"role":70,"phone":51,"phoneExt":51,"email":100},"Zakir Soltanov, MA","info@tedqiqat.com",{"type":102,"investigatorFullName":51,"investigatorTitle":51,"investigatorAffiliation":51,"oldNameTitle":51,"oldOrganization":51},"SPONSOR",[104],{"name":105,"class":106},"National Institute of Mental Health (NIMH)","NIH","100576648","multi-level-child-mental-health-interventions-in-azerbaijan-100576648",false,"NCT06788028","Multi-level Child Mental Health Interventions in Azerbaijan","Optimizing Multi-level Interventions to Improve Child Mental Health in Azerbaijan","AZ CMH","Inclusion Criteria:\n\n1. The child is between ages 7 and 14;\n2. The child is at-risk for mental health problems as measured by one of the following criteria:\n\n   1. Elevated child emotional behavioral problems as indexed by 'high' or 'very high' scores on the Strengths and Difficulties Questionnaire (SDQ, total difficulty score or any of the four difficulty subscales - emotional, conduct, hyperactivity, or peer problems); OR\n   2. Parental risk factor - parental elevated emotional distress, as indexed by 'severe' or 'extremely severe\" score on any of the DASS-21 subscales (DASS-21 Stress = 27; Anxiety = 15; or Depression = 15);\n3. The child and parent (or other primary caregiver) can commit to study participation.\n\nIf a family has more than one eligible child, participation in the study will be offered to the older child. If both the eligible child and caregiver provide consent, they will be enrolled in the study.\n\nAll eligible children within a family can be enrolled in the study.\n\nExclusion Criteria:\n\nParticipants will be excluded from participation in the study if the child, the parent or the participating caregiver is assessed to have a cognitive impairment that would interfere with their ability to provide informed consent. This will be assessed during the consent process. As part of the informed consent process, conducted through an Azeri speaking research assistant, potential participants will also be asked to state their understanding of areas addressed during the informed consent discussion including (1) the nature and extent of participation in the study; (2) risks involved with participation; and (3) the potential benefits of participation in the study. If a participant is unable to respond to any of the three items, this youth\u002Fcaregiver pair will be excluded from the study.\n\nChildren and parents will also be excluded if one of them has significant behavioral, and\u002For mental health impairment (e.g., development disorder, autism, psychosis, high symptoms of trauma or depression) that could interfere with either with their ability to benefit from the prevention program or to participate safely. Research Assistants will ask parents about any of these conditions during the screening process.",true,"ALL","7 Years","14 Years",{"count":120,"type":121},1200,"ESTIMATED","INTERVENTIONAL",[124],"NA","To improve mental health outcomes among children aged 7-14 from low-income families in Azerbaijan, this study will refine and test three evidence-based intervention approaches: family-strengthening intervention; trauma-focused mental health services; and economic empowerment in the form of Child Savings Accounts.\n\nBased on prior research on the mental health of deinstitutionalized children conducted by this U.S.-Azerbaijani team in collaboration with a local Community Collaborative Board, these intervention components have been adapted to maximize fit to the cultural context of Azerbaijan. In this study, the adapted interventions will be tested with 600 child-caregiver dyads in a trial using the Multiphase Optimization Strategy (MOST) to compare different intervention components and identify the most optimal combination. Given the limited human and financial resources in low- and middle-income countries (LMICs), it will be important to identify whether each of these interventions is necessary and\u002For sufficient for improving the mental health of children.\n\nThe study will test the effects of each intervention component on children's mental health outcomes (symptoms of depression, anxiety; disruptive behaviors; post-traumatic symptoms;), on associated cognitive and social processes (e.g., attention, emotion recognition bias) and functional outcomes (e.g., academic performance). The study will also examine the mediating pathway associated with each intervention component.",[127,128,129],"Mental Health","Child Externalizing Problems","Child Behavior Problem",[78,131,132,53,61,133],"Children","Child Mental Health","Child and Family Well-being","2025-04-03",{"date":136,"type":137},"2025-04-06","ACTUAL",{"date":139,"type":137},"2025-03-01",{"date":141,"type":121},"2029-01-31",{"name":5,"class":6},2]