[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627383":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":34,"locations":44,"responsibleParty":65,"collaborators":67,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":23,"enrollmentInfo":87,"targetDuration":23,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":105,"whyStopped":23,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Uppsala University","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Self Help plus","EXPERIMENTAL","Families assigned to this arm receive the World Health Organization's Self-Help Plus (SH+), a brief, group-based stress-management program for caregivers. The two primary caregivers in each family participate. SH+ is delivered by trained non-specialist facilitators using a standardized, audio-guided format with an illustrated self-help manual and structured group discussion. The program consists of five sessions (about two hours each), with at least three days between sessions.",[13],"Behavioral: Self Help Plus",{"label":15,"type":10,"description":16,"interventionNames":17},"Self-Help Plus + Interaction Competencies with Children - for Parents (SH+ + ICC-P)","Families assigned to this arm receive SH+ first, followed by Interaction Competencies with Children for Parents (ICC-P). The two primary caregivers in each family participate. SH+ is delivered as described above (five group sessions, approximately two hours each, spaced at least three days apart, delivered by trained non-specialists using standardized audio-guided materials and an illustrated manual). After SH+ is completed, caregivers receive ICC-P, a participatory parenting program designed to strengthen positive, responsive caregiving and reduce harsh or violent discipline. ICC-P is delivered as three consecutive full training days plus one refresher training day six weeks later, following a manualized group format.",[13,18],"Behavioral: Interaction Competencies with Children - for Parents",{"label":20,"type":21,"description":22,"interventionNames":23},"Usual Care (Control)","NO_INTERVENTION","Participants in this arm receive Usual Care (UC). At baseline, caregivers are provided with a standardized information leaflet describing existing mental health and psychosocial support services available in the refugee camp, including organization names, contact information, and types of services offered. No structured intervention is delivered as part of this arm.",null,[25,30],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"BEHAVIORAL","Self Help Plus","The Self-Help Plus (SH+) intervention is a stress management program developed by the World Health Organization (WHO). It is based on Acceptance and Commitment Therapy and designed for use in resource-limited and humanitarian settings. SH+ is delivered in five group sessions led by trained non-specialist facilitators using pre-recorded audio, structured manuals, and illustrated participant guides in Kiswahili. The program teaches practical skills for coping with stress and managing difficult thoughts and emotions. Each session lasts approximately two hours and includes individual reflection and guided group discussion.",[9,15],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":23},"Interaction Competencies with Children - for Parents","ICC-P is a four-day, group-based intervention designed to strengthen positive parenting and reduce harsh or violent discipline. It combines theoretical input with practical exercises, group discussions, and role-playing. A refresher session is held six weeks later to reinforce learning and promote sustainability. Both interventions are delivered by trained facilitators under supervision to ensure fidelity.",[15],[35,40],{"name":36,"role":37,"phone":38,"phoneExt":23,"email":39},"Jonathan Hall, PhD","CONTACT","+46709948737","jonathan.hall@pcr.uu.se",{"name":41,"role":37,"phone":42,"phoneExt":23,"email":43},"Sofia Nordenving","+46730555351","sofia.nordenving@pcr.uu.se",[45,56],{"facility":46,"status":23,"city":47,"state":48,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":50,"geoPoint":55,"contacts":23},"Dar es Salaam University College of Education","Dar es Salaam","Dar es Salaam Region","Tanzania",{"type":51,"coordinates":52},"Point",[53,54],39.26951,-6.82349,{"lat":54,"lon":53},{"facility":46,"status":23,"city":47,"state":48,"zip":23,"country":49,"countryCode":23,"cosmosGeoPoint":57,"geoPoint":59,"contacts":60},{"type":51,"coordinates":58},[53,54],{"lat":54,"lon":53},[61],{"name":62,"role":37,"phone":63,"phoneExt":23,"email":64},"Faustine Bwire Masath, PhD","+255 714 662 061","faustine.masath@udsm.ac.tz",{"type":66,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[68,70,72,74],{"name":69,"class":6},"Bielefeld University",{"name":71,"class":6},"University of Konstanz",{"name":46,"class":73},"UNKNOWN",{"name":75,"class":6},"University of North Carolina, Charlotte","100627383","combining-mental-health-and-parenting-interventions-to-improve-child-wellbeing-among-refugee-families-in-tanzania-100627383",false,"NCT07447921","Combining Mental Health and Parenting Interventions to Improve Child Wellbeing Among Refugee Families in Tanzania","Combining Mental Health and Violence Prevention Interventions to Enhance Child Wellbeing Under Adversity - Study Protocol for a Three-arm, Cluster-randomized, Superiority Trial With Primary Caregivers in Nyarugusu Refugee Camp, Tanzania (WEMA Trial)","WEMA","Inclusion Criteria:\n\n* Families residing in Nyarugusu Refugee Camp, Tanzania\n* Congolese refugee origin (for cultural and linguistic homogeneity)\n* Two primary caregivers (one male, one female) aged 18 years or older, caring for at least two children aged 7-10 years\n* Ability to speak and understand Kiswahili\n* Willingness to provide informed consent (and child assent)\n* No plans to leave the camp within the next 12 months\n\nExclusion Criteria:\n\n* Caregivers currently enrolled in other mental health or parenting programs\n* Caregivers displaying imminent suicide risk, psychosis, or severe cognitive impairment that would impede participation\n* Children with known developmental disabilities reported by caregivers",true,"ALL","7 Years",{"count":88,"type":89},1296,"ESTIMATED","INTERVENTIONAL",[92],"NA","The goal of this clinical trial is to learn whether improving caregivers' mental health and parenting practices can enhance child wellbeing among Congolese refugee families living in the Nyarugusu Refugee Camp, Tanzania. The WEMA trial (\"Wellbeing through combined Evidence-based tools for Mental health and Attuned parenting\") is a three-arm, family-level cluster-randomized, controlled superiority trial involving 324 families (approximately 648 children aged 7-10 years and their two primary caregivers). Participants and intervention facilitators will know which program a family receives, but outcome assessors (enumerators) will not know group assignment.\n\nThe main questions it aims to answer are:\n\n* Does Self-Help Plus (SH+), a World Health Organization (WHO) group stress-management program, improve children's emotional and behavioral functioning at 12 months post-intervention, compared with usual care?\n* Does adding Interaction Competencies with Children for Parents (ICC-P), a participatory parenting program, after SH+ further improve children's emotional and behavioral functioning at 12 months post-intervention, compared with SH+ alone?\n\nResearchers will compare (1) Usual Care, (2) SH+, and (3) SH+ followed by ICC-P to see whether SH+ improves outcomes versus usual care, and whether SH+ followed by ICC-P provides additional benefits beyond SH+ alone.\n\nParticipants will:\n\n* Be assigned by chance by family clusters to one of three groups: Usual Care, SH+, or SH+ followed by ICC-P.\n* Receive either (a) information about available psychosocial and mental health services (Usual Care), (b) SH+ (five group sessions delivered by trained non-specialists), or (c) SH+ followed by ICC-P (a four-day participatory parenting training to strengthen positive parenting and reduce harsh discipline).\n* Complete study assessments at baseline, 3 months, and 12 months post-intervention.\n\nThe primary outcome is children's emotional and behavioral functioning, measured using the Pediatric Symptom Checklist-17 (PSC-17) at 12 months post-intervention. Secondary outcomes include children's wellbeing and quality of life, as well as caregivers' mental health, well-being, and parenting practices. Additional exploratory outcomes will also be assessed, including measures collected from caregivers and behavioral tasks with children.\n\nThe trial is implemented by Uppsala University in collaboration with the Dar es Salaam University College of Education (DUCE) and partners, with funding from the Swedish Research Council (grant no. 2022-02476).",[95,96,97,98],"Mental Health","Socio-emotional Well-being","Functioning, Psychosocial","Parenting Behavior",[100,101,102,103,104,31,49],"Mental health","Child development","Parenting","Refugees","Self-Help Plus","NOT_YET_RECRUITING","2026-02-25",{"date":108,"type":109},"2026-03-04","ACTUAL",{"date":111,"type":89},"2026-03-15",{"date":113,"type":89},"2027-07",{"name":5,"class":6},2]