An interventional study of Economic Empowerment (EE) and Multiple Family Group based Family Strengthening (MFG-based FS) in Child Behavioral Health, sponsored by Washington University School of Medicine. Active, not recruiting at 1 site in Uganda. Open to participants aged 10 Years to 14 Years. Per ClinicalTrials.gov, last updated 2026-01-13.
Sponsored by Washington University School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.
This study's enrollment of 967 is above the median of 140 across 197 interventional studies indexed under Child Behavior.
Browse Child Behavior studies →Washington University School of Medicine is the lead sponsor of 1,803 studies on the registry; 271 are open to participants now.
Of its 329 completed or terminated interventional studies of FDA-regulated products, 216 (66%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria for children:
Inclusion criteria for caregivers:
Exclusion criteria:
-Inability to understand study procedures and participant rights as assessed during the /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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Behavioral: Economic Empowerment (EE)
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.
Behavioral: Multiple Family Group based Family Strengthening (MFG-based FS)
EE+ MFG-based FS combines both the child development account and 16 sessions of MFG.
Behavioral: EE plus MFG-based FS
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.
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.
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.
Change in oppositional defiant disorder symptoms (reported by guardian)
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.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in impairment (reported by guardian)
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.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in child depression symptoms
Change in child depression will be measured using the Child Depression Inventory. The study will measure the mean score on the CDI scale over time. The total score range between 0 and 28 with a high score indicating higher levels of depressive symptoms.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Child Post Traumatic Stress Disorder (PTSD) symptoms
Post traumatic stress will be measured using the Child PTSD reaction index. The study will measure the mean score on the Child PTSD Reaction Scale over time. The total score range between 0 and 120, with a high score indicating higher levels of PTSD.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in self concept
Self concept will be measured using the Tennessee self-concept scale. The study will measure the mean score on the TSCS over time. The total score range between 20 and 100 with a high score indicating higher levels of self-concept.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Family relations
Family relations will be measured using items adapted from the family environmental scale and Family assessment scale. The study will measure the mean score over time, with higher scores indicating high levels of family relations/cohesion.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Social Support
Social Support from family members and friends will be measured using the social support behaviors scale. The study will measure the mean score over time. The total score range between 45- 225, with a higher score indicating high social support levels.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Family stability
Family stability will be assessed by asking respondents to indicate how long they have lived with their current family.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in mental health-related stigma
Mental health-related stigma will be measured using the pediatric self-stigmatization scale. The study will measure mean scores over time. The total score range between 13 -52, with higher scores indicating high levels of mental health-related stigma.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in hopelessness symptoms
Hopelessness will be measured using the Beck Hopelessness Scale. The study will assess the mean scores over time. The total score range between 0 - 20, with a higher score indicating higher levels of child hopelessness.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Self Esteem
Self esteem will be measured using Rosenberg Self-Esteem Scale. The study will assess the mean scores over time. The total score range between10 - 40, with a higher score indicating high levels of child self esteem.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in food insecurity and assets
This will be measured using Household Food Insecurity Scale and Asset ownership. Total mean scores of both scales will be measured over time with a range of 0-25 and 0-21 respectively. A higher score indicates high levels of food security, economic stability and assets ownership.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Access to services
The study will measure the change in access to medical services as well as barriers to medical services over time.
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Savings
Savings will be measured using official bank records/ monthly bank statements from the Child Development Accounts
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Perceived Social Support
Perceived support from family members, friends and other individual will be measured using the Multidimensional Scale of Perceived Social Support. The study will measure the mean score on the MSPSS over time. The scale range between 12-84, with a higher score indicating high levels of perceived social support.
Time frame: Baseline, 12 months, 24 months, 36 months
Plan to share: Yes — Once all of the data has been de-identified, cleaned, and validated, and main findings have been published, the Investigators expect to share data with the scientific community. The research team will make datasets available to any individual who makes a direct request to the PI and indicates the data will be used for the purposes of research (per Code of Federal Regulations Title 45 Part 46: "Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge."). In sharing participant data, the team will follow Washington University in St. Louis' Office of SponsoredProjects' data sharing agreement.
Supporting information: Study protocol, Analytic code
No publications or documents are linked to this record.
Started Jun 2022 (actual). Primary completion is estimated for Mar 2027, 56 months after the start.
Of 140 non-industry interventional studies with no phase under Child Behavior, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 42. This study's planned 56 months is above that.
Counting every sponsor, half of 141 studies reached it within 20 months; a quarter within 8 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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