Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda - Full Text View

Purpose

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.

Condition	Intervention
Poverty Orphaned Children AIDS Orphans	Behavioral: Bridges Behavioral: Bridges PLUS Other: Usual Care


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda

Resource links provided by NLM:

MedlinePlus related topics: Toddler Development

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Savings and Asset Accumulation [ Time Frame: 12-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Increased confidence in saving ability and stronger financial stability. Accumulation of formal and informal savings and wealth/assets (e.g. livestock, type of housing, land); and change in attitudes toward saving.
Educational Achievement [ Time Frame: 12-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.
Mental Health Functioning [ Time Frame: 12-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.
Sexual Risk-Taking Behavior [ Time Frame: 12-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.
Savings and Asset Accumulation [ Time Frame: 24-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Increased confidence in saving ability and stronger financial stability. Accumulation of formal and informal savings and wealth/assets (e.g. livestock, type of housing, land); and change in attitudes toward saving.
Educational Achievement [ Time Frame: 24-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.
Mental Health Functioning [ Time Frame: 24-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.
Sexual Risk-Taking Behavior [ Time Frame: 24-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.
Savings and Asset Accumulation [ Time Frame: 36-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Increased confidence in saving ability and stronger financial stability. Accumulation of formal and informal savings and wealth/assets (e.g. livestock, type of housing, land); and change in attitudes toward saving.
Educational Achievement [ Time Frame: 36-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.
Mental Health Functioning [ Time Frame: 36-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.
Sexual Risk-Taking Behavior [ Time Frame: 36-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.
Savings and Asset Accumulation [ Time Frame: 48-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Increased confidence in saving ability and stronger financial stability. Accumulation of formal and informal savings and wealth/assets (e.g. livestock, type of housing, land); and change in attitudes toward saving.
Educational Achievement [ Time Frame: 48-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations.
Mental Health Functioning [ Time Frame: 48-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms.
Sexual Risk-Taking Behavior [ Time Frame: 48-month post-intervention follow-up assessment ] [ Designated as safety issue: No ]
Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.


Estimated Enrollment:	1440
Study Start Date:	February 2012
Estimated Study Completion Date:	July 2016
Primary Completion Date:	February 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Bridges	Behavioral: Bridges 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. Other Name: Child Development Account Other: Usual Care 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 Name: Usual Services
Experimental: Bridges PLUS	Behavioral: Bridges PLUS 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. Other Name: Child Development Account Other: Usual Care 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 Name: Usual Services
Usual Care	Other: Usual Care 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 Name: Usual Services

Detailed 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.

Eligibility


Ages Eligible for Study:	11 Years to 17 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447615

Locations


Uganda
International Center for Child Health and Asset Development
Masaka, Rakai and Masaka Districts, Uganda

Sponsors and Collaborators

Columbia University

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Investigators


Principal Investigator:	Fred M Ssewamala, PhD	Columbia University

More Information


Responsible Party:	Fred Ssewamala, PhD, Associate Professor, Columbia University
ClinicalTrials.gov Identifier:	NCT01447615 History of Changes
Other Study ID Numbers:	AAA11950 1R01HD070727-01
Study First Received:	October 4, 2011
Last Updated:	May 19, 2016
Health Authority:	United States: Institutional Review Board Uganda: National Council for Science and Technology

Keywords provided by Columbia University:


Orphaned children and youth Economic empowerment Uganda HIV/AIDS Sub-Saharan Africa

ClinicalTrials.gov processed this record on September 29, 2016