Child Behavioral HealthNCT05368714
Suubi4StrongerFamilies
A study testing Economic Empowerment (EE), Multiple Family Group based Family Strengthening (MFG-based FS) and EE plus MFG-based FS in people with Child Behavioral Health, run by Washington University School of Medicine at 1 site in Uganda.
Trial 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). Read more about this study
- Who is it for?
- Ages 10 to 14 years
- Conditions the study is for
- Child Behavioral Health
- What is being tested?
- Economic Empowerment (EE), Multiple Family Group based Family Strengthening (MFG-based FS) and EE plus MFG-based FS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 967 participants
- Where
- 1 siteUganda
- Study dates
- 14 Jun 2022to 1 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- -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 locations and contacts
1 site in 1 country.
About this study
Official title: Suubi4StrongerFamilies: Addressing Child Behavioral Health by Strengthening Financial Stability and Parenting Among Families in Uganda
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.
Read the 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
- Being tested
- Economic Empowerment (EE), Multiple Family Group based Family Strengthening (MFG-based FS), EE plus MFG-based FS
- Keywords
- children, adolescents, child behavior, disruptive behaviors
- Medical subject headings
- Child Behavior, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Economic Empowerment (EE)Behavioural
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 based Family Strengthening (MFG-based FS)Behavioural
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 FSBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Economic Empowerment (EE) | Experimental | 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). Receives: Behavioral: Economic Empowerment (EE) |
| Multiple Family Group (MFG) - based Family Strengthening (FS) Intervention: | Experimental | 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. Receives: Behavioral: Multiple Family Group based Family Strengthening (MFG-based FS) |
| Combined EE plus MFG-based FS | Experimental | EE+ MFG-based FS combines both the child development account and 16 sessions of MFG. Receives: Behavioral: EE plus MFG-based FS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 12 months, 24 months, 36 months
Secondary outcomes (13)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: Baseline, 12 months, 24 months, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start14 Jun 2022
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Behavioral HealthStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- None (open label)
- Enrolment
- 967 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Fred Ssewamala, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368714
- Sponsor's protocol ID
- R01MH128905
- Other IDs
- R01MH128905
- Status last verified
- Jan 2026
- First submitted
- 1 May 2022
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suubi4StrongerFamilies: Addressing Child Behavioral Health by Strengthening Financial Stability and Parenting Among Families in Uganda
- ClinicalTrials.gov ID
- NCT05368714
- Acronym / sponsor ID
- R01MH128905
- Conditions
- Child Behavioral Health
- Keywords
- children, adolescents, child behavior, disruptive behaviors
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 967 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 14 Jun 2022 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Economic Empowerment (EE) | Experimental | Behavioral: 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). |
| Multiple Family Group (MFG) - based Family Strengthening (FS) Intervention: | Experimental | Behavioral: Multiple Family Group based Family Strengthening (MFG-based FS)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. |
| Combined EE plus MFG-based FS | Experimental | Behavioral: EE plus MFG-based FSEE+ MFG-based FS combines both the child development account and 16 sessions of MFG. |
Who may qualify
- Ages
- 10 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- -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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Economic Empowerment (EE) |
| 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. | Behavioural | Multiple Family Group (MFG) - based Family Strengthening (FS) Intervention: |
| EE plus MFG-based FSEE 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. | Behavioural | Combined EE plus MFG-based FS |
Primary outcome
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.
13 secondary outcomes
Change in child depression symptoms
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Child Post Traumatic Stress Disorder (PTSD) symptoms
Time frame: Baseline, 12 months, 24 months, 36 months
Change in self concept
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Family relations
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Social Support
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Family stability
Time frame: Baseline, 12 months, 24 months, 36 months
Change in mental health-related stigma
Time frame: Baseline, 12 months, 24 months, 36 months
Change in hopelessness symptoms
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Self Esteem
Time frame: Baseline, 12 months, 24 months, 36 months
Change in food insecurity and assets
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Access to services
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Savings
Time frame: Baseline, 12 months, 24 months, 36 months
Change in Perceived Social Support
Time frame: Baseline, 12 months, 24 months, 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Economic Empowerment (EE), Multiple Family Group based Family Strengthening (MFG-based FS) and EE plus MFG-based FS in people with Child Behavioral Health, run by Washington University School of Medicine at 1 site in Uganda.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in oppositional defiant disorder symptoms (reported by guardian) (time frame: Baseline, 12 months, 24 months, 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2026.