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Combining Mental Health and Parenting Interventions to Improve Child Wellbeing Among Refugee Families in Tanzania (WEMA) 1.296 Randomizado Pediátrico
Os detalhes do estudo clínico estão disponíveis principalmente em inglês. No entanto, a IA Trial Radar pode ajudar! Basta clicar em 'Explicar o estudo' para visualizar e discutir as informações do estudo no idioma selecionado.
O estudo clínico NCT07447921 (WEMA) é um estudo intervencionista para Saúde mental, Socio-emotional Well-being, Funcionamento psicossocial, Parenting Behavior. Seu status atual é: ainda não recrutando. O recrutamento está programado para iniciar em 15 de março de 2026, com o objetivo de incluir 1.296 participantes. Coordenado por a Universidade de Uppsala e deve ser concluído em 1 de julho de 2027. Essas informações foram atualizadas no ClinicalTrials.gov em 4 de março de 2026.
Resumo
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 ...Mostrar mais
Título oficial
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)
Condições médicas
Saúde mentalSocio-emotional Well-beingFuncionamento psicossocialParenting BehaviorPublicações
Artigos científicos e trabalhos de pesquisa publicados sobre este estudo clínico:- Kabelege E, Kirika A, Nkuba M, Hermenau K, Schreiber A, Hoeffler A, Hecker T. Improving Parent-Child Interaction and Reducing Parental Violent Discipline - a Multi-Informant Multi-Method Pilot Feasibility Study of a School-Based Intervention. J Fam Violence. 2025;40:799-810. doi: 10.1007/s10896-023-00679-4.
Outros IDs do estudo
- WEMA
- 2022-02476
Número NCT
Data de início (real)
2026-03-15
Última atualização postada
2026-03-04
Data de conclusão (estimada)
2027-07
Inscrição (estimada)
1.296
Tipo de estudo
Intervencionista
FASE
N/A
Status
Ainda não recrutando
Palavras-chave
Mental health
Child development
Parenting
Refugees
Self-Help Plus
Interaction Competencies with Children - for Parents
Tanzania
Child development
Parenting
Refugees
Self-Help Plus
Interaction Competencies with Children - for Parents
Tanzania
Propósito principal
Tratamento
Alocação do design
Randomizado
Modelo de intervenção
Paralelo
Cegamento (Mascaramento)
Cego simples
Braços / Intervenções
| Grupo de participantes/Braço | Intervenção/Tratamento |
|---|---|
ExperimentalSelf Help plus 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 (abo...Mostrar mais | 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 pr...Mostrar mais |
ExperimentalSelf-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 co...Mostrar mais | 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 pr...Mostrar mais 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. |
Nenhuma intervençãoUsual Care (Control) 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. | N/A |
Desfecho primário
Desfecho secundário
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Caregiver-reported child emotional and behavioral functioning (Pediatric Symptom Checklist-17, PSC-17) | Emotional and behavioral functioning of children aged 7-10 years will be assessed using the Pediatric Symptom Checklist-17 (PSC-17), a 17-item caregiver-report screening tool for psychosocial problems (total score range 0-34; higher scores indicate greater difficulties). Each child's PSC-17 will be completed independently by both primary caregivers. The primary outcome metric is the mean (average) of the two caregiver-reported PSC-17 total scores for each child at 12 months post-intervention. PSC-17 subscales (internalizing, externalizing, attention) will be examined in secondary/exploratory analyses. | Baseline, 3 months post-intervention, and 12 months post-intervention |
| Medida de desfecho | Descrição da medida | Prazo |
|---|---|---|
Self-reported child emotional and behavioral functioning (Youth-adapted Pediatric Symptom Checklist-17, Y-PSC-17) | Mental health problems in children will be assessed using a youth self-report version of the Pediatric Symptom Checklist-17 (PSC-17), adapted for child administration with newly developed pictorial response aids. The measure includes 17 items rated on a 3-point scale (Never, Sometimes, Often; scored 0-2) and summed to a total score (0-34), with higher scores indicating greater emotional/behavioral difficulties. Subscale scores for internalizing, externalizing, and attention problems will also be derived and examined separately. | Baseline and 12-months post-intervention |
Child health-related quality of life (KINDL-R) | Children's health-related quality of life will be assessed using the revised KINDL questionnaire (KINDL-R), which measures well-being across six domains: physical, emotional, self-esteem, family, friends, and school. Both the 24-item child self-report (Kid-KINDL-R) and parent proxy versions will be used. Items are rated on a 5-point Likert scale, with higher scores indicating better quality of life. | Baseline, 3 months post-intervention, and 12 months post-intervention |
Psychological distress (Kessler Psychological Distress Scale, K6) | General psychological distress among caregivers will be assessed using the 6-item Kessler Psychological Distress Scale (K6). Items capture symptoms of anxiety and depression experienced during the past month. Each item is scored from 0 ("none of the time") to 4 ("all of the time"), with higher scores reflecting greater distress. | Baseline, 3 months post-intervention, and 12 months post-intervention |
Depression (Patient Health Questionnaire-9, PHQ-9) | Caregiver depression symptoms will be measured using the 9-item Patient Health Questionnaire (PHQ-9). Items assess frequency of depressive symptoms during the past two weeks on a 4-point scale (0-3), with higher scores indicating greater severity of depression. | Baseline, 3 months post-intervention, and 12 months post-intervention |
Anxiety (Generalized Anxiety Disorder 7-item scale, GAD-7) | Symptoms of generalized anxiety among caregivers will be assessed using the GAD-7. The 7 items rate frequency of core anxiety symptoms over the past two weeks on a scale from 0 ("not at all") to 3 ("nearly every day"). Higher scores indicate greater anxiety severity. | Baseline, 3 months post-intervention, and 12 months post-intervention |
Post-traumatic stress symptoms (PTSD Checklist-Civilian Version, PCL-C) | Caregiver post-traumatic stress symptoms will be assessed with the 6-item PTSD Checklist-Civilian Version (PCL-C). Each symptom is rated on a 5-point scale from "not at all" to "extremely," with total scores ranging from 6 to 30. Higher scores indicate greater PTSD symptom severity. | Baseline, 3 months post-intervention, and 12 months post-intervention |
Subjective wellbeing (WHO-5 Well-Being Index) | The WHO-5 Well-Being Index will assess caregivers' subjective wellbeing. It consists of five items rated from 0 ("at no time") to 5 ("all of the time") reflecting mood, vitality, and general interest. The total score (0-25) is multiplied by 4 to yield a final index ranging from 0 to 100, where higher scores indicate better wellbeing. | Baseline, 3 months post-intervention, and 12 months post-intervention |
Functional impairment (WHO Disability Assessment Schedule 2.0, WHODAS-II) | Functional impairment among caregivers will be measured using the 15-item WHO Disability Assessment Schedule 2.0 (WHODAS-II). Items assess difficulties in understanding, mobility, self-care, interpersonal relationships, daily activities, and participation, scored from 0 ("none") to 4 ("extreme or cannot do"). Higher scores indicate greater functional impairment. | Baseline and 12 months post-intervention |
Psychological flexibility (Acceptance and Action Questionnaire-II, AAQ-II) | Psychological flexibility will be measured using the 7-item Acceptance and Action Questionnaire-II (AAQ-II). Items are rated on a 7-point Likert scale (1 = "never true," 7 = "always true"), and scores are reversed so that higher totals indicate greater psychological flexibility. | Baseline, 3 months post-intervention, and 12 months post-intervention |
Positive parenting (Alabama Parenting Questionnaire - Positive Parenting Subscale) | Positive parenting practices will be measured using the 6-item Positive Parenting Subscale of the Alabama Parenting Questionnaire (APQ). Items assess the frequency of positive interactions between parents and children on a 5-point scale from "never" to "always," with higher scores indicating greater use of positive parenting behaviors. | Baseline, 3 months post-intervention, and 12 months post-intervention |
Child-reported maltreatment (Child-Reported CTSPC) | Child-reported maltreatment will be assessed with a pictorial adaptation of the Parent-Child Conflict Tactics Scale (CTSPC). The instrument includes 22 items rated on a 7-point frequency scale for the past month; higher scores indicate more frequent maltreatment experiences. | Baseline and 12 months post-intervention |
Child discipline/maltreatment (caregiver report): UNICEF MICS Child Discipline Module | Caregiver-reported child discipline will be assessed using the UNICEF Multiple Indicator Cluster Surveys (MICS) Child Discipline Module, which includes 11 yes/no items capturing both non-violent and violent discipline practices in the past month. Summary indices are derived from the item responses; higher values indicate more frequent use of harsh/violent discipline practices. | Baseline, 3 months post-intervention, and 12 months post-intervention |
Assistente de participação
Critérios de elegibilidade
Idades elegíveis
Criança, Adulto, Idoso
Idade mínima
7 Years
Sexos elegíveis
Todos
Aceita voluntários saudáveis
Sim
- Families residing in Nyarugusu Refugee Camp, Tanzania
- Congolese refugee origin (for cultural and linguistic homogeneity)
- Two primary caregivers (one male, one female) aged 18 years or older, caring for at least two children aged 7-10 years
- Ability to speak and understand Kiswahili
- Willingness to provide informed consent (and child assent)
- No plans to leave the camp within the next 12 months
- Caregivers currently enrolled in other mental health or parenting programs
- Caregivers displaying imminent suicide risk, psychosis, or severe cognitive impairment that would impede participation
- Children with known developmental disabilities reported by caregivers
- 🎓Bielefeld Univ...
Contato central do estudo
Contato: Jonathan Hall, PhD, +46709948737, [email protected]
Contato: Sofia Nordenving, +46730555351, [email protected]
2 Locais do estudo em 1 países
Dar es Salaam Region
Dar es Salaam University College of Education, Dar es Salaam, Dar es Salaam Region, Tanzania
Dar es Salaam University College of Education, Dar es Salaam, Dar es Salaam Region, Tanzania
Faustine Bwire Masath, PhD, Contato, +255 714 662 061, [email protected]