Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01447615
Other study ID # AAA11950
Secondary ID 1R01HD070727-01
Status Completed
Phase N/A
First received
Last updated
Start date February 2012
Est. completion date January 15, 2018

Study information

Verified date October 2018
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 1410
Est. completion date January 15, 2018
Est. primary completion date January 15, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 11 Years to 17 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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:
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).

Locations

Country Name City State
Uganda International Center for Child Health and Asset Development Masaka Rakai And Masaka Districts

Sponsors (2)

Lead Sponsor Collaborator
Columbia University Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Primary Savings and Asset Accumulation 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. 12-month post-intervention follow-up assessment
Primary Educational Achievement School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations. 12-month post-intervention follow-up assessment
Primary Mental Health Functioning Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms. 12-month post-intervention follow-up assessment
Primary Sexual Risk-Taking Behavior Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs. 12-month post-intervention follow-up assessment
Primary Savings and Asset Accumulation 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. 24-month post-intervention follow-up assessment
Primary Educational Achievement School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations. 24-month post-intervention follow-up assessment
Primary Mental Health Functioning Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms. 24-month post-intervention follow-up assessment
Primary Sexual Risk-Taking Behavior Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs. 24-month post-intervention follow-up assessment
Primary Savings and Asset Accumulation 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. 36-month post-intervention follow-up assessment
Primary Educational Achievement School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations. 36-month post-intervention follow-up assessment
Primary Mental Health Functioning Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms. 36-month post-intervention follow-up assessment
Primary Sexual Risk-Taking Behavior Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs. 36-month post-intervention follow-up assessment
Primary Savings and Asset Accumulation 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. 48-month post-intervention follow-up assessment
Primary Educational Achievement School enrollment and attendance. Educational attainment, plans, and aspirations. Performance on National Primary Leaving Examinations. 48-month post-intervention follow-up assessment
Primary Mental Health Functioning Degree of hopefulness about the future. Ability to identify specific future goals. Level of mental health functioning. Depressive symptoms. 48-month post-intervention follow-up assessment
Primary Sexual Risk-Taking Behavior Ability to negotiate safe sex practices. Decreased intentions to engage in sexual risk behavior. Knowledge about and attitude toward HIV/AIDS and other STDs. 48-month post-intervention follow-up assessment
See also
  Status Clinical Trial Phase
Not yet recruiting NCT06335745 - PediCARE Health Equity Intervention in High-Risk Neuroblastoma N/A
Completed NCT02858011 - The Effect of a Cash Transfer Program and Preventive Nutrition Packages on Household Welfare and Child Nutritional Status in Mali Phase 4
Active, not recruiting NCT02459184 - addressInG iNcome securITy in Primary carE N/A
Completed NCT03958214 - Promoting Self-Regulation Skills and Healthy Eating Habits in Early Head Start N/A
Completed NCT05783336 - Stepping Stones and Creating Futures Plus Pilot N/A
Completed NCT02959866 - Implementation and Impact of an Online Tool Used in Primary Care to Improve Income Security N/A
Completed NCT01703936 - Ex-combatant Reintegration in Liberia N/A
Recruiting NCT05091957 - Connecting Families N/A
Completed NCT03562910 - Mobile-based Social Services Screening and Referral Tool in an Pediatric Emergency Department N/A
Recruiting NCT05667675 - Targeting Child Mental Health and Household Poverty N/A
Completed NCT00223834 - Pathways to Vocational Rehabilitation: Enhancing Entry and Retention N/A
Recruiting NCT04857775 - Adaptation and Pilot Testing of Web and Mobile Interface for the ATTACHâ„¢ Intervention N/A
Completed NCT01163695 - The SUUBI Program: Asset-Ownership for Orphaned Children in Uganda Phase 1
Recruiting NCT06119074 - A Novel Unconditional Gifted Savings Program N/A
Terminated NCT03940300 - Farming for Life - Health Impact of Organic Vegetable Prescriptions for Adults Living With or at Risk of Type 2 Diabetes N/A
Completed NCT03102775 - Comprehensive Follow-up of Low Income Families. A Cluster-randomized Study N/A
Completed NCT05144750 - Fruit and Vegetable Prescription in the Community Health Center Setting N/A
Completed NCT03226548 - Effect of EITC on Biological Markers of Aging, Health and Mortality N/A
Not yet recruiting NCT04461080 - Screening for Poverty And Related Social Determinants to Improve Knowledge of and Links to Resources (SPARK) N/A
Completed NCT00971022 - Discount Generic Prescription Study N/A