[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100570030":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":24,"locations":18,"responsibleParty":34,"collaborators":18,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":18,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":18,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":58,"overallStatus":64,"whyStopped":18,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":18},{"fullName":5,"class":6},"University of Ghana","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Multiple family group therapy intervention arm","EXPERIMENTAL","ALHIV and their families will be invited to participate in 16 program sessions, each lasting 90 minutes, and will be held on clinic days over a period of 14 weeks.\n\nThe MFG will combine group discussions and activities fostering support, learning and interaction both within the family and among families. The MFG intervention will be delivered by parent peers and community health workers trained by the study team",[13],"Other: Multiple family group intervention therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Arm","NO_INTERVENTION","Clinic allocated to the control group will continue with treatment as usual. This group will not receive the MFGT until after the study period when they may be considered to also receive the intervention to ensure all participants eventually benefit from the program. Until then, the control group will receive the usual standard of care including adherence counselling, adherence support, health education and medical care.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"Multiple family group intervention therapy","Overview The intervention will be implemented at designated clinics where adolescents living with HIV\u002FAIDS (ALHIV) and their families currently receive care. These sites will provide the MFG intervention alongside standard care services. All eligible adolescents and their family members who consent to participate will be included in the intervention group.\n\nProgram Structure The MFG intervention consists of 16 structured sessions, each running for 90 minutes. Sessions will be scheduled to coincide with clinic days over a 14-week period to maximize accessibility and attendance. Parent peers and community health workers, trained by the research team, will facilitate these group sessions.\n\nSession Format Sessions on the MFGT will begin with introducing participants to one another, the facilitators, and the program curriculum. Subsequent sessions will concentrate on areas such as respectful communication, support, resilience building, problem-solving, conflict resolution, stress management",[9],[25,30],{"name":26,"role":27,"phone":28,"phoneExt":18,"email":29},"Samuel Adjorlolo, PhD, MPhil, MSc, BSc, RN","CONTACT","0240592635","sadjorlolo@ug.edu.gh",{"name":31,"role":27,"phone":32,"phoneExt":18,"email":33},"Dorothy Serwaa Boakye, PGDE,MPhil, MA, BSc, RN","0249924121","dsboakye001@st.ug.edu.gh",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Dorothy Serwaa Boakye","Ms","100570030","multiple-family-group-intervention-programming-to-improve-mental-health-of-adolescents-living-with-hiv-in-ghana-an-implementation-science-approach-100570030",false,"NCT06701942","Multiple-Family Group Intervention Programming to Improve Mental Health of Adolescents Living With HIV in Ghana: An Implementation Science Approach","Multiple-Family Group Intervention Programming to Improve Mental Health of Adolescents Living With HIV\u002FAIDS in Ghana: An Implementation Science Study Protocol.","Inclusion Criteria:\n\n* Adolescents:\n\nAged 10-19 years (as per WHO definition of adolescence) Confirmed HIV-positive status Currently receiving antiretroviral therapy (ART) Aware of their HIV status Residing in Lower Manya Krobo district Able to communicate in either English or the local language Willing to participate in group sessions\n\nCaregivers\u002Ffamily:\n\nPrimary caregiver of an eligible adolescent participant Aged 18 years or older Aware of the adolescent\\'s HIV status Residing in Lower Manya Krobo district Able to communicate in either English or the local language Willing to participate in group sessions\n\nExclusion Criteria:\n\n* Adolescents:\n\nPresence of severe cognitive impairment that would prevent participation in group activities Acute psychiatric conditions requiring immediate intensive treatment Current participation in another mental health intervention study Unable to provide assent or obtain caregiver consent\n\nPrimary Caregivers\u002FFamily:\n\nPresence of severe cognitive impairment that would prevent participation in group activities Acute psychiatric conditions requiring immediate intensive treatment Unable to provide informed consent\n\nBoth Adolescents and Caregivers:\n\nPlanning to relocate outside of Lower Manya Krobo district within the next 12 months Unable to commit to attending the majority of planned group sessions","ALL","10 Years","19 Years",{"count":49,"type":50},80,"ESTIMATED","INTERVENTIONAL",[53],"NA","When young people living with HIV don't get the mental health support they need, it can lead to a lot of problems. Not only do they suffer from mental health issues, but it also makes it harder for them to stick to their HIV treatment, practice safe sex, go to school regularly, and do well in their studies.\n\nBecause of these challenges, experts are urging that we take action to address the mental health needs of these adolescents. They believe that our healthcare system should provide a more comprehensive approach that includes mental health services for these young people. This would not only improve their HIV treatment but also give more people access to mental healthcare around the world.\n\nBeing a teenager with HIV is especially difficult, so it's crucial they get the right support, including help with their mental health, to navigate this stage of life. However, many studies show that mental health issues in young people living with HIV, especially in poorer areas, are often ignored. These places often have underfunded and poorly organized healthcare systems, making it even harder to address these problems.\n\nThere have been significant advances in treating and preventing HIV, and with the right medication, young people with HIV can now live almost as long as those without the virus. Ghana, like many other countries, has committed to the global goal of ensuring that 95% of people living with HIV are diagnosed, 95% of those diagnosed start treatment, and 95% of those on treatment achieve and maintain low levels of the virus. But these goals are hard to reach without addressing the significant mental health and substance abuse issues faced by adolescents living with HIV.\n\nIn Ghana and other low-resource areas, the healthcare system is struggling. Mental health services are rarely included in the basic healthcare that young people living with HIV receive. Most psychiatric units in hospitals are underfunded, so these young people are often referred to specialized hospitals for mental health support. However, financial difficulties, distance, and other barriers prevent many from accessing these services, leaving their mental health needs unmet.\n\nTo address this issue, it's essential to integrate mental health services into primary care for adolescents living with HIV. One promising approach is the Multiple Family Group Therapy (MFGT), which could provide much-needed support in these settings.\n\nMultiple Family Group Therapy (MFGT) is a very affordable way to address the emotional and social challenges faced by young people living with HIV and their families. It's a proven method that's listed in the U.S. national registry of effective programs because it uses minimal resources to achieve positive mental health outcomes for many participants.\n\nMFGT was initially designed to help children with behavior problems and their parents, but it has since been used to address a wide range of issues like depression and anxiety in different groups, including people living with HIV. The program is structured and combines group and family therapy, focusing on building skills and improving family dynamics through what are called the 4Rs (Rules, Responsibility, Relationship, and Respectful communication) and 2Ss (Stress and Social support).\n\nThe main goal of MFGT is to create a space where families who are dealing with similar challenges can support each other and learn together, all with the aim of improving mental health and behavior. The program helps participants stay engaged with healthcare services, stick to their treatment, reduce symptoms, prevent relapses, and improve their overall quality of life.\n\nAlthough MFGT was developed in the West and is based on several theories like family systems and social learning, it has been successfully adapted for use in low-resource settings like Ghana. It's particularly appealing in these areas because it can be facilitated by non-professionals such as lay counselors, community health workers, or even parents. This aligns with the World Health Organization's strategy of task-shifting, which involves training non-mental health professionals to provide basic mental health support.",[56,57],"Depressive Disorder","Anxiety Disorder (Panic Disorder or GAD)",[59,60,61,62,63],"Multiple family group therapy","Adolescents","HIV\u002FAIDS","Depression","Anxiety","NOT_YET_RECRUITING","2024-11-19",{"date":67,"type":68},"2024-11-22","ACTUAL",{"date":70,"type":50},"2025-01-15",{"date":72,"type":50},"2026-12-30",{"name":5,"class":6}]