Overview

This trial is active, not recruiting.

Conditions poverty, orphaned children, aids orphans
Treatments bridges, bridges plus, usual care
Sponsor Columbia University
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date February 2012
End date February 2016
Trial size 1440 participants
Trial identifier NCT01447615, 1R01HD070727-01, AAA11950

Summary

Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda, represents the first study that measures medium-term efficacy and cost-effectiveness of a family economic empowerment intervention for AIDS-orphaned children. The usual care provided to AIDS orphans in sub-Saharan Africa consists mainly of informal counseling as well as limited material support (e.g., specifically school lunches, textbooks for the required subjects, and note-books). Given the challenges facing these children and their caregivers, further supports are needed in order to help them successfully make the transition from primary school to secondary school and into adolescence. In the context of resource-poor countries, interventions that improve families' economic capabilities are likely to be particularly consequential. Both theory and prior research indicate that economic instability (including poverty) constitutes one of the primary risk factors for AIDS-orphaned children's risk-taking behaviors (including sexual risk-taking), poor mental health functioning, and poor educational outcomes. Thus, the lack of economic security constitutes an important risk factor for AIDS-orphaned children. Yet, to-date, few interventions aimed at care and support of AIDS-orphaned children have incorporated components to address family-level poverty/economic instability of the children and their caregiving families. Within this context, there is a need for innovative interventions that promote sustainable (more than short-term) economic and behavior change among AIDS-orphaned children and create the supports necessary to sustain these changes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
bridges Child Development Account
Each child participant in the Bridges Arm will receive the usual care in addition to a Child Development Account (CDA) to be used for secondary education by the AIDS-orphaned child. The CDA will be a matched savings account held in the child's name in a financial institution registered by the Central Bank (Bank of Uganda). The account will be matched with money from the program at a match rate of 1:1. Additionally, participants will receive: 1) twelve 1-2 hour workshops focused on asset building, future planning, and protection from risks; 2) mentorship sessions to reinforce learning and build optimism; and 3) a family income-generating /micro-enterprise promotion component for children enrolled in Bridges and their families.
usual care Usual Services
Participants in the usual care condition will receive usual care for AIDS-orphaned children in the study area. This includes: counseling, school lunches, and scholastic materials (textbooks and notebooks). Counseling will be provided by priests in the community (as is currently done).
(Experimental)
bridges plus Child Development Account
Each child participant in the Bridges PLUS Arm will receive the usual care in addition to a Child Development Account (CDA) to be used for secondary education by the AIDS-orphaned child. The CDA will be a matched savings account held in the child's name in a financial institution registered by the Central Bank (Bank of Uganda). The account will be matched with money from the program at a match rate of 2:1. Additionally, participants will receive: 1) twelve 1-2 hour workshops focused on asset building, future planning, and protection from risks; 2) mentorship sessions to reinforce learning and build optimism; and 3) a family income-generating /micro-enterprise promotion component for children enrolled in Bridges PLUS and their families.
usual care Usual Services
Participants in the usual care condition will receive usual care for AIDS-orphaned children in the study area. This includes: counseling, school lunches, and scholastic materials (textbooks and notebooks). Counseling will be provided by priests in the community (as is currently done).
(Other)
usual care Usual Services
Participants in the usual care condition will receive usual care for AIDS-orphaned children in the study area. This includes: counseling, school lunches, and scholastic materials (textbooks and notebooks). Counseling will be provided by priests in the community (as is currently done).

Primary Outcomes

Measure
Savings and Asset Accumulation
time frame: 12-month post-intervention follow-up assessment
Educational Achievement
time frame: 12-month post-intervention follow-up assessment
Mental Health Functioning
time frame: 12-month post-intervention follow-up assessment
Sexual Risk-Taking Behavior
time frame: 12-month post-intervention follow-up assessment
Savings and Asset Accumulation
time frame: 24-month post-intervention follow-up assessment
Educational Achievement
time frame: 24-month post-intervention follow-up assessment
Mental Health Functioning
time frame: 24-month post-intervention follow-up assessment
Sexual Risk-Taking Behavior
time frame: 24-month post-intervention follow-up assessment
Savings and Asset Accumulation
time frame: 36-month post-intervention follow-up assessment
Educational Achievement
time frame: 36-month post-intervention follow-up assessment
Mental Health Functioning
time frame: 36-month post-intervention follow-up assessment
Sexual Risk-Taking Behavior
time frame: 36-month post-intervention follow-up assessment
Savings and Asset Accumulation
time frame: 48-month post-intervention follow-up assessment
Educational Achievement
time frame: 48-month post-intervention follow-up assessment
Mental Health Functioning
time frame: 48-month post-intervention follow-up assessment
Sexual Risk-Taking Behavior
time frame: 48-month post-intervention follow-up assessment

Eligibility Criteria

Male or female participants from 11 years up to 17 years old.

Inclusion Criteria: - An HIV/AIDS-orphaned child (a child who has lost one or both parents to HIV/AIDS) - Enrolled in grade 5 or 6 of primary school - Living within a family Exclusion Criteria: - Any child who does not self-identify as an HIV/AIDS-orphan - Any child who is not enrolled in grade 5 or 6 of primary school - Any child who is not living within a family at the time of enrollment

Additional Information

Official title Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda
Principal investigator Fred M Ssewamala, PhD
Description The overall goal of the proposed research is to evaluate the efficacy and cost-effectiveness of an innovative family-based economic empowerment intervention for AIDS-orphaned children. This will be accomplished via a three-group cluster randomized control trial (RCT). The three groups are: Bridges, Bridges PLUS, and usual care for AIDS-orphaned children. There will be five assessment points: baseline (pretest), 12, 24, 36, and 48-months post-intervention initiation. The intervention, "Bridges to the Future" (Bridges) will be guided by asset-theory and both Bridges and Bridges PLUS will include the following intervention components tested in the two earlier pilot studies, SEED-Uganda and SUUBI-Uganda: 1) workshops focused on asset building, future planning, and protection from risks; 2) mentors to reinforce learning and build optimism; 3) a Child Development Account (CDA) that can be used for secondary education by the AIDS-orphaned child; and 4) a family income generating/micro-enterprise promotion component for children enrolled in Bridges and Bridges PLUS, and their families.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by Columbia University.