[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602658":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":146,"collaborators":148,"id":161,"slug":162,"hasResults":163,"nctId":164,"briefTitle":165,"officialTitle":166,"acronym":25,"eligibilityCriteria":167,"healthyVolunteers":168,"sex":169,"minAge":170,"maxAge":25,"enrollmentInfo":171,"targetDuration":25,"studyType":174,"phases":175,"briefSummary":177,"conditions":178,"keywords":180,"overallStatus":185,"whyStopped":25,"lastUpdateSubmitDate":186,"lastUpdatePostDateStruct":187,"startDateStruct":190,"completionDateStruct":192,"leadSponsor":194,"locationsCount":195},{"fullName":5,"class":6},"Deakin University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Family Foundations","EXPERIMENTAL","Families allocated to FF will receive the program via one of the trial satellite sites within 2 weeks of randomisation.",[13],"Behavioral: Family Foundations",{"label":15,"type":16,"description":17,"interventionNames":18},"Family Life Check In","ACTIVE_COMPARATOR","Families allocated to the Family Life Check-In will receive this condition from a Clinical Research Nurse, employed through the primary site (Deakin University) within 2 weeks of randomisation.",[19],"Behavioral: Family Life Check-In",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BEHAVIORAL","FF is an 8-session program for families of children aged 0-12 years targeting parent mental health and family conflict. It will be delivered via telehealth by an allied health professional (i.e., social work, psychology, counselling qualification) trained in FF. The 8 sessions can be delivered flexibly (1 or 2 sessions per week). The duration between sessions can vary as per the needs of the family. We are allowing up to 11 weeks from randomisation for FF to be completed. FF is a manualised program which provides instruction on discussion activities, skills practice, video and workbook exercises for every session. Sessions are based around the content areas of: emotion regulation, stress management, healthy communication, coparenting, conflict resolution, and problem solving.",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Family Life Check-In","Families allocated to Family Life Check In will receive this condition from a Clinical Research Nurse, employed at the Primary site (deakin University) with 2 weeks of randomisation. This brief intervention will be comparable to care typically provided to parents\u002Fcaregivers seeking support for mental health difficulties and\u002For family\u002Fparent relationships issues from a community health service at intake. Family Life Check-In involves a brief (\\~30 minute) telephone consultation involving: a) an assessment of the families' needs with one or all parents, b) referral to local services including GP to discuss a mental health care plan, c) provision of reputable Australian web-based resources about supporting children during crises (Raising Children Network, Phoenix Disaster Recovery), and (d) telephone and online support services (BeyondBlue; Lifeline, PANDA, MensLine, KidsLine, Parentline).",[15],[31],{"name":32,"affiliation":5,"role":33},"Rebecca Giallo","PRINCIPAL_INVESTIGATOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Rebecca L Giallo, PhD","CONTACT","+61431101643","r.giallo@deakin.edu.au",{"name":41,"role":37,"phone":25,"phoneExt":25,"email":42},"Alison Fogarty","ali.fogarty@deakin.edu.au",[44,59,79,97,112,131],{"facility":5,"status":25,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Burwood","Victoria","3125","Australia","AU",{"type":51,"coordinates":52},"Point",[53,54],145.11901,-37.84978,{"lat":54,"lon":53},[57],{"name":58,"role":37,"phone":38,"phoneExt":25,"email":39},"Rebecca GIallo, PhD",{"facility":60,"status":25,"city":61,"state":46,"zip":62,"country":48,"countryCode":49,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"Colac Area Health","Colac","3250",{"type":51,"coordinates":64},[65,66],143.58489,-38.339,{"lat":66,"lon":65},[69,73,76,78],{"name":70,"role":37,"phone":71,"phoneExt":25,"email":72},"Laura Alston","(03) 5232 5100","laura.alston@deakin.edu.au",{"name":74,"role":37,"phone":25,"phoneExt":25,"email":75},"Ruth Hamilton","rhamilton@cah.vic.gov.au",{"name":74,"role":77,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":70,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":80,"status":25,"city":81,"state":46,"zip":82,"country":48,"countryCode":49,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Holstep Health","Melbourne","3058",{"type":51,"coordinates":84},[85,86],144.96332,-37.814,{"lat":86,"lon":85},[89,93,96],{"name":90,"role":37,"phone":91,"phoneExt":25,"email":92},"Samantha Bladon","+61409706727","samantha.bladon@holstephealth.org.au",{"name":94,"role":37,"phone":91,"phoneExt":25,"email":95},"Gail Evans","Gail.Evans@holstephealth.org.au",{"name":90,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":98,"status":25,"city":99,"state":46,"zip":100,"country":48,"countryCode":49,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"The Bridge Youth Service","Shepparton","3632",{"type":51,"coordinates":102},[103,104],145.39867,-36.38047,{"lat":104,"lon":103},[107,111],{"name":108,"role":37,"phone":109,"phoneExt":25,"email":110},"Melinda Lawley","(03)58312390","MLawley@thebridge.org.au",{"name":108,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":113,"status":25,"city":114,"state":46,"zip":115,"country":48,"countryCode":49,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"Kids First","Wallan","3756",{"type":51,"coordinates":117},[118,119],144.97859,-37.41625,{"lat":119,"lon":118},[122,126,129,130],{"name":123,"role":37,"phone":124,"phoneExt":25,"email":125},"Zoe Martin","0394500900","zmartin@kidsfirstaustralia.org.au",{"name":127,"role":37,"phone":124,"phoneExt":25,"email":128},"Monique Yeoman","myeoman@kidsfirstaustralia.org.au",{"name":127,"role":77,"phone":25,"phoneExt":25,"email":25},{"name":123,"role":33,"phone":25,"phoneExt":25,"email":25},{"facility":132,"status":25,"city":133,"state":46,"zip":134,"country":48,"countryCode":49,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Brophy Family & Youth Services","Warrnambool","3280",{"type":51,"coordinates":136},[137,138],142.48799,-38.38176,{"lat":138,"lon":137},[141,145],{"name":142,"role":37,"phone":143,"phoneExt":25,"email":144},"Peter Hill","1300276749","phill@brophy.org.au",{"name":142,"role":33,"phone":25,"phoneExt":25,"email":25},{"type":147,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR",[149,151,153,154,156,158,159],{"name":150,"class":6},"La Trobe University",{"name":80,"class":152},"UNKNOWN",{"name":60,"class":152},{"name":155,"class":152},"Brophy Family & Youth Service",{"name":157,"class":152},"The Bridge",{"name":113,"class":152},{"name":160,"class":6},"Murdoch Childrens Research Institute","100602658","the-family-foundations-trial-100602658",false,"NCT07126379","The Family Foundations Trial","The Family Foundations Trial: Promoting Family Wellbeing in Regional and Rural Communities Affected by Environmental Threats","Inclusion Criteria:\n\n* Family must be living in a regional or rural area\n* Family must have at least one child aged 0-12 years\n* At least 2 parents\u002Fcaregivers in the family must agree to participate in evaluation, and FF, if allocated. (Please note: A family member or someone else involved in raising children in the family may participate in FF. Families are not required to be in a couple relationship or living together).\n* At least one parent\u002Fcaregiver within the family reports mental health difficulties and\u002For two or more risk factors for poor mental health in the last 5 years including (a) experienced a recent or past natural disaster (i.e., drought, flood, fire, severe storm), (b) living with the threat of a natural disaster (i.e., bushfires during summer), (c) self-reported history of poor mental health, (d) financial hardship, (e) young parental age at time of first baby (18-25yrs), (f) relationship conflict, or (g) social isolation.\n\nExclusion Criteria:\n\n* At least one parent has a severe mental health disorder - self reported psychosis, substance use dependency, prescribed anti-psychotic medication that may interfere with their ability to take part in the trial and in the FF intervention if allocated. They may require more intensive mental health interventions and treatment than what can be provided by the trial interventions.\n* The family has an overt indicator of family violence - self-reported intervention order or court case for family violence.\n* The family has child protection service involvement - self-reported.",true,"ALL","18 Years",{"count":172,"type":173},472,"ESTIMATED","INTERVENTIONAL",[176],"NA","In this project, researchers are exploring different ways to support the wellbeing and relationships of families with young children (0-12 years). People in regional and rural communities often live with the threat of bushfires, floods, drought, severe storms, and other extreme weather events. Some families have been affected by these disasters and are still trying to recover.\n\nResearchers will test two different ways of supporting families in regional and rural Victoria:\n\nFamily Foundations (FF): An 8-session program to promote parent wellbeing, parenting partnerships, and communication. All parents\u002Fcaregivers\u002Fparenting partners in the family participate in sessions delivered by a health professional online.\n\nFamily Life Check-In: A brief 30-minute telephone call with a health professional to discuss family wellbeing and relationships, and identify any supports needed.\n\nThe goal of this trial is to learn whether FF works to reduce mental health difficulties for regional and rural families. The main question it aims to answer is:\n\nCompared to Family Life Check-In, does Family Foundations lead to fewer mental health difficulties?\n\nParticipants will:\n\nComplete an online survey before randomisation, after they have received FF or Family Life Check-In, and six months after starting the project.\n\nTake part in either Family Foundations or Family Life Check-In.",[179],"Mental Health Outcomes",[181,182,183,184],"mental health","parent mental health","coparenting","rural health","NOT_YET_RECRUITING","2025-08-13",{"date":188,"type":189},"2025-08-17","ACTUAL",{"date":191,"type":173},"2025-10-01",{"date":193,"type":173},"2027-08-01",{"name":5,"class":6},6]