Clinical trial NCT05368714: Suubi4StrongerFamilies
Official title: Suubi4StrongerFamilies: Addressing Child Behavioral Health by Strengthening Financial Stability and Parenting Among Families in Uganda
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Child Behavioral Health
Keywords: children
adolescents
child behavior
disruptive behaviors
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2022-05-10
Enrollment: 968
Sex: ALL
Minimum age (years): 10
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of three study conditions: 1) economic empowerment (EE) only, 2) multiple family group-based family strengthening (MFG-based FS), 3) combined EE+MFG-based FS.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in oppositional defiant disorder symptoms (reported by guardian)
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in impairment (reported by guardian)
timeFrame: Baseline, 12 months, 24 months, 36 months
Secondary outcomes:
measure: Change in child depression symptoms
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in Child Post Traumatic Stress Disorder (PTSD) symptoms
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in self concept
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in Family relations
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in Social Support
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in Family stability
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in mental health-related stigma
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in hopelessness symptoms
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in Self Esteem
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in food insecurity and assets
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in Access to services
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in Savings
timeFrame: Baseline, 12 months, 24 months, 36 months
measure: Change in Perceived Social Support
timeFrame: Baseline, 12 months, 24 months, 36 months
Other outcomes:
Locations:
city: Masaka
country: Uganda
facility: International Center for Child Health and Development
Study officials:
References: