Suubi4StrongerFamilies

NCT05368714 | Active Not Recruiting

• 1 other identifier: R01MH128905
• Study Type: interventional
• Target: 967
• Locations: 1 country
• Sites: 1

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.

Conditions

Child Behavioral Health

Keywords

children; adolescents; child behavior; disruptive behaviors

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 12 months, 24 months, 36 months

Secondary Outcomes (13)

• Change in child depression symptoms

  Baseline, 12 months, 24 months, 36 months

• Change in Child Post Traumatic Stress Disorder (PTSD) symptoms

  Baseline, 12 months, 24 months, 36 months

• Change in self concept

  Baseline, 12 months, 24 months, 36 months

• Change in Family relations

  Baseline, 12 months, 24 months, 36 months

• Change in Social Support

  Baseline, 12 months, 24 months, 36 months

Study Arms (3)

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).

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.

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.

Behavioral: EE plus MFG-based FS

Interventions

Economic Empowerment (EE) 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.

Economic Empowerment (EE)

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

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

EE plus MFG-based FS 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.

Combined EE plus MFG-based FS

Eligibility Criteria

• Age: 10 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH): collaborator
• Washington University School of Medicine: lead

Study Sites (1)

International Center for Child Health and Development

Masaka, Uganda

Location

MeSH Terms

Conditions

Child Behavior; Problem Behavior

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 1, 2022
• First Posted: May 10, 2022
• Study Start: June 14, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE

Locations

UG (1)