Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda
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| ClinicalTrials.gov Identifier: NCT01447615 |
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Recruitment Status :
Active, not recruiting
First Posted : October 6, 2011
Last Update Posted : July 21, 2017
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Sponsor:
Columbia University
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Fred Ssewamala, PhD, Columbia University
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Brief 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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Poverty Orphaned Children AIDS Orphans | Behavioral: Bridges Behavioral: Bridges PLUS Other: Usual Care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 1440 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Supportive Care |
| Official Title: | Bridges to the Future: Economic Empowerment for AIDS-Orphaned Children in Uganda |
| Study Start Date : | February 2012 |
| Actual Primary Completion Date : | July 31, 2016 |
| Estimated Study Completion Date : | July 2018 |
| Arm | Intervention/treatment |
|---|---|
| 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 |
Primary Outcome Measures :
- Savings and Asset Accumulation [ Time Frame: 12-month post-intervention follow-up assessment ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 11 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Fred Ssewamala, PhD, Associate Professor, Columbia University |
| ClinicalTrials.gov Identifier: | NCT01447615 History of Changes |
| Other Study ID Numbers: |
AAA11950 1R01HD070727-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | October 6, 2011 Key Record Dates |
| Last Update Posted: | July 21, 2017 |
| Last Verified: | July 2017 |
Keywords provided by Fred Ssewamala, PhD, Columbia University:
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Orphaned children and youth Economic empowerment Uganda HIV/AIDS Sub-Saharan Africa |