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临床试验/NCT05368714
NCT05368714进行中(未招募)不适用

Suubi4StrongerFamilies: Addressing Child Behavioral Health by Strengthening Financial Stability and Parenting Among Families in Uganda

Washington University School of Medicine1 个研究点 分布在 1 个国家目标入组 967 人开始时间: 2022年6月14日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
967
试验地点
1
主要终点
Change in oppositional defiant disorder symptoms (reported by guardian)

研究概览

简要总结

The study will examine the mechanisms by which Economic Empowerment (EE) and Family Strengthening (FS) interventions targeting social, familial and context-specific drivers affect childhood behavioral health (CBH). The study will randomly assign 900 children in mid-upper primary school (10 to 14 years) to one of the three study arms (10 schools each): 1) EE only (n=300), 2) Multiple Family Group (MFG)-based FS only (n=300), and 3) combined EE+MFG-based FS (n=300). The interventions will be provided for 12 months. Assessments will occur at baseline, 12, 24 and 36 months.

详细描述

Children in Sub-Saharan Africa (SSA) are burdened by significant unmet mental health needs, with prevalence rates higher than 20%. The high rates of poverty, food insecurity, stigma and an inadequate health safety net system exacerbate serious childhood behavioral health (CBH) needs and impede an effective response. Youth disruptive behavioral disorders (DBDs) are a particularly serious concern as they persist through adolescence and adulthood. DBDs are also highly related to poor physical health and interpersonal challenges in adulthood. There is a need to address the context-specific social influences on CBH. Moreover, if children's needs are to be met in SSA, then: 1) implementing interventions designed and tested in SSA, and which mobilize resources within existing child-focused institutions (families, schools) is critical; 2) combined interventions that simultaneously target SSA-specific influences on CBH (family financial stability, culturally-based parenting), and can be delivered in collaboration with child/family-serving community settings (schools, faith-based and financial institutions) are necessary; and 3) group, community and population approaches to CBH are needed to drive scalable solutions.

This study will test the impact of Economic Empowerment (EE) and Family Strengthening (FS) interventions on childhood behavioral health. The study will utilize a longitudinal design with three active study conditions across 30 cluster-randomized primary schools to compare single and combination intervention options. The three study conditions are: 1) EE only, 2) MFG-based FS only, 3) combined EE+MFG-based FS. The interventions will be provided for 12 months; and assessments will occur at baseline, 12, 24 and 36 months.

The study will be guided by the following specific aims:

Aim 1: Examine the impact of EE only, MFG-based FS only, and combined EE+MFG-based FS on children's DBD symptoms and behavioral functioning;

Aim 2: Test the influence of EE only, MFG-based FS only, and combined EE+MFG-based FS on family financial stability (e.g., food and housing stability, material assets, savings), parenting and protective family processes (e.g., family organization, caregiver/child interaction, cohesion, support) and perceptions related to help-seeking (e.g., stigma) on CBH and functioning; and assess whether these change mechanisms mediate intervention effects on DBD symptoms and behavioral functioning, and explore moderation by context-specific moderators of intervention effects;

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
10 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • for children:
  • Child in upper primary 5-7 (10 to 14 years)
  • Meeting criteria for Opposition Defiant Disorder (ODD) or Conduct Disorder (CD)
  • Willing to assent;
  • Inclusion criteria for caregivers:
  • Adult caregiver of the child willing to consent
  • Available for research and intervention activities.

排除标准

  • Inability to understand study procedures and participant rights as assessed during the informed consent/assent process with the child or parent. If the child or adult caregiver presents with emergency needs (e.g., hospitalization), needed care will be secured, rather than study participation.

研究组 & 干预措施

Economic Empowerment (EE)

Experimental

EE consists of a child development account (CDA) held in the child's name in a financial institution registered by the Central Bank (Bank of Uganda).

干预措施: Economic Empowerment (EE) (Behavioral)

Multiple Family Group (MFG) - based Family Strengthening (FS) Intervention:

Experimental

MFG-based consists of 16 sessions focused on building support for parents and families by providing opportunities for parents and children to communicate in a safe setting with other families who have shared experiences. Core components of MFG are known as 4Rs and 2S's: rules, responsibility, relationships, respectful communication, stress and social support.

干预措施: Multiple Family Group based Family Strengthening (MFG-based FS) (Behavioral)

Combined EE plus MFG-based FS

Experimental

EE+ MFG-based FS combines both the child development account and 16 sessions of MFG.

干预措施: EE plus MFG-based FS (Behavioral)

结局指标

主要结局

Change in oppositional defiant disorder symptoms (reported by guardian)

时间窗: Baseline, 12 months, 24 months, 36 months

Change in oppositional defiant disorder symptoms will be measured using Iowa Conners scale. The scale has 16 items, with a score of 6 or higher on items 6-10 signifying positive oppositional disorder.

Change in impairment (reported by guardian)

时间窗: Baseline, 12 months, 24 months, 36 months

Change in child impairment impairment will be measured using the impairment scale. The scale has 7 items. A score of 3 or higher in any 4 or more items is considered a significant impairment.

次要结局

  • Change in Child Post Traumatic Stress Disorder (PTSD) symptoms(Baseline, 12 months, 24 months, 36 months)
  • Change in Access to services(Baseline, 12 months, 24 months, 36 months)
  • Change in child depression symptoms(Baseline, 12 months, 24 months, 36 months)
  • Change in self concept(Baseline, 12 months, 24 months, 36 months)
  • Change in Family relations(Baseline, 12 months, 24 months, 36 months)
  • Change in Self Esteem(Baseline, 12 months, 24 months, 36 months)
  • Change in food insecurity and assets(Baseline, 12 months, 24 months, 36 months)
  • Change in Family stability(Baseline, 12 months, 24 months, 36 months)
  • Change in mental health-related stigma(Baseline, 12 months, 24 months, 36 months)
  • Change in Savings(Baseline, 12 months, 24 months, 36 months)
  • Change in Social Support(Baseline, 12 months, 24 months, 36 months)
  • Change in hopelessness symptoms(Baseline, 12 months, 24 months, 36 months)
  • Change in Perceived Social Support(Baseline, 12 months, 24 months, 36 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fred Ssewamala

Professor

Washington University School of Medicine

研究点 (1)

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