Suubi4StrongerFamilies

NCT ID: NCT05368714

Last Updated: 2026-01-13

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 967 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-14
• Study Completion Date: 2027-04-01

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.

Conditions

Child Behavioral Health

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Economic Empowerment (EE)

Intervention Type: BEHAVIORAL

EE will be provided via a child development account (CDA). CDAs provide children with basic financial education, introduce them to formal financial institutions, and incentivize them to save by matching their deposits. Any of the child's family members, relatives, or friends will be allowed and encouraged to contribute towards the CDA. The account will be matched with money from the program. The maximum family contribution to be matched by the program will be an equivalent of US $10 per month per family or US $120 for the 12-month intervention period.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

MFG-based FS approach is a family-centered, group delivered, evidence-informed, strength-based intervention designed for children and adolescents whose families struggle with poverty and associated stressors. MFG is based 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. The core components of MFG are known as 4Rs and 2S's: rules, responsibility, relationships, respectful communication, stress and social support. Participants in this study arm will receive 16 session of MFG-based FS sessions, delivered by delivered by trained Community Health Workers and Parent Peers.

Combined EE plus MFG-based FS

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

Group Type: EXPERIMENTAL

EE plus MFG-based FS

Intervention Type: BEHAVIORAL

EE plus MFG-based FS directly addresses both the economic needs and mental health functioning. It will consists of an EE intervention that comprises a family monetary savings program using CDAs, and a family-based dialogue and training via MFG focused on strengthening family relationships and mental health challenges.

Interventions

Economic Empowerment (EE)

EE will be provided via a child development account (CDA). CDAs provide children with basic financial education, introduce them to formal financial institutions, and incentivize them to save by matching their deposits. Any of the child's family members, relatives, or friends will be allowed and encouraged to contribute towards the CDA. The account will be matched with money from the program. The maximum family contribution to be matched by the program will be an equivalent of US $10 per month per family or US $120 for the 12-month intervention period.

Intervention Type: BEHAVIORAL

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

MFG-based FS approach is a family-centered, group delivered, evidence-informed, strength-based intervention designed for children and adolescents whose families struggle with poverty and associated stressors. MFG is based 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. The core components of MFG are known as 4Rs and 2S's: rules, responsibility, relationships, respectful communication, stress and social support. Participants in this study arm will receive 16 session of MFG-based FS sessions, delivered by delivered by trained Community Health Workers and Parent Peers.

Intervention Type: BEHAVIORAL

EE plus MFG-based FS

EE plus MFG-based FS directly addresses both the economic needs and mental health functioning. It will consists of an EE intervention that comprises a family monetary savings program using CDAs, and a family-based dialogue and training via MFG focused on strengthening family relationships and mental health challenges.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Child in upper primary 5-7 (10 to 14 years)
• Meeting criteria for Opposition Defiant Disorder (ODD) or Conduct Disorder (CD)
• Willing to assent;

• 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Fred Ssewamala

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

International Center for Child Health and Development

Masaka, , Uganda

Countries

Uganda

Other Identifiers

R01MH128905

Identifier Type: NIH

Identifier Source: secondary_id

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R01MH128905

Identifier Type: NIH

Identifier Source: org_study_id

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