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Clinical Trials/NCT05368714
NCT05368714
Active, not recruiting
Not Applicable

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

Washington University School of Medicine1 site in 1 country967 target enrollmentJune 14, 2022

Overview

Phase
Not Applicable
Intervention
Economic Empowerment (EE)
Conditions
Child Behavioral Health
Sponsor
Washington University School of Medicine
Enrollment
967
Locations
1
Primary Endpoint
Change in oppositional defiant disorder symptoms (reported by guardian)
Status
Active, not recruiting
Last Updated
3 months ago

Overview

Brief Summary

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.

Detailed Description

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; Aim 3: Qualitatively examine participants' experiences with each intervention arm.

Registry
clinicaltrials.gov
Start Date
June 14, 2022
End Date
April 1, 2027
Last Updated
3 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Fred Ssewamala

Professor

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

Economic Empowerment (EE)

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).

Intervention: Economic Empowerment (EE)

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

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.

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

Combined EE plus MFG-based FS

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

Intervention: EE plus MFG-based FS

Outcomes

Primary Outcomes

Change in oppositional defiant disorder symptoms (reported by guardian)

Time Frame: 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)

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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