Suubi4StrongerFamilies

The Washington University

Status: Active, not recruiting

Conditions: Child Behavioral Health

Treatments: Behavioral: Economic Empowerment (EE); Behavioral: EE plus MFG-based FS; Behavioral: Multiple Family Group based Family Strengthening (MFG-based FS)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05368714

R01MH128905

Details and patient eligibility

About

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.

Full 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.

Enrollment: 967 patients

Sex: All

Ages: 10 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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967 participants in 3 patient groups

Economic Empowerment (EE)

Experimental group

Description:

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).

Treatment:

Behavioral: Economic Empowerment (EE)

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

Experimental group

Description:

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.

Treatment:

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

Combined EE plus MFG-based FS

Experimental group

Description:

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

Treatment:

Behavioral: EE plus MFG-based FS