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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01163695
Other study ID # AAAA5337
Secondary ID R21MH076475-01
Status Completed
Phase Phase 1
First received July 14, 2010
Last updated March 13, 2014
Start date June 2005
Est. completion date January 2009

Study information

Verified date March 2014
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review BoardUganda: National Council for Science and Technology
Study type Interventional

Clinical Trial Summary

This study examines an economic empowerment model of care and support for orphaned adolescents in rural Uganda. The Suubi intervention focuses on economic empowerment of families caring for orphaned youths. It attempts to address the health risks and poor educational achievements resulting from poverty and limited options.


Description:

The AIDS epidemic and a 20‐year civil war have had a devastating impact on Uganda. The events have led to population displacement, worsening living conditions, exacerbation of poverty, and disruption of already weakened social service systems. As implemented, the Suubi Project goes considerably beyond the usual care, which primarily consists of institutionalization and reactive strategies (involving food and material aid). Specifically, the intervention promotes children's savings accounts, also known as children development accounts, for postprimary education and microenterprise development (i.e., development of small income‐generating businesses).

The Suubi intervention is grounded in asset theory (Sherraden 1990, 1991), which holds that assets (e.g., savings, educational opportunities, and economic opportunities in the form of income‐generating activities or microenterprises) have important economic, social, and psychological benefits for individuals and families. Asset building is increasingly viewed as a critical factor for reducing poverty, improving psychosocial functioning, and positively affecting attitudes and behaviors.


Recruitment information / eligibility

Status Completed
Enrollment 286
Est. completion date January 2009
Est. primary completion date June 2008
Accepts healthy volunteers No
Gender Both
Age group 11 Years to 17 Years
Eligibility Inclusion Criteria:

- an orphaned child, defined as a child who has lost one or both parents to HIV/AIDS; enrolled in primary school (even though possibly not attending regularly); between the ages of 12 to 15 years.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Behavioral:
Children's development account
Children in the experimental condition (the SUUBI program) received, in addition to the usual care, an economic empowerment intervention aimed at promoting asset accumulation for families—and consisting of three major components: 1) workshops focused on asset-building and future planning; 2) a monthly mentorship program for adolescents with peer mentors on life options; and 3) a Child Development Account (CDA), dedicated to paying for secondary schooling, vocational training and/or a family small business. The CDAs were matched savings accounts, with a match rate of 2:1 as an incentive for participants to save, but with a limit on the maximum savings that could be matched (the match cap, in this case, was equivalent to $10 a month).

Locations

Country Name City State
Uganda St. Joseph's Matale Parish Rakai

Sponsors (2)

Lead Sponsor Collaborator
Columbia University National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

Uganda, 

References & Publications (4)

Ssewamala FM, Alicea S, Bannon WM Jr, Ismayilova L. A novel economic intervention to reduce HIV risks among school-going AIDS orphans in rural Uganda. J Adolesc Health. 2008 Jan;42(1):102-4. — View Citation

Ssewamala FM, Han CK, Neilands TB, Ismayilova L, Sperber E. Effect of economic assets on sexual risk-taking intentions among orphaned adolescents in Uganda. Am J Public Health. 2010 Mar;100(3):483-8. doi: 10.2105/AJPH.2008.158840. Epub 2010 Jan 14. — View Citation

Ssewamala FM, Han CK, Neilands TB. Asset ownership and health and mental health functioning among AIDS-orphaned adolescents: findings from a randomized clinical trial in rural Uganda. Soc Sci Med. 2009 Jul;69(2):191-8. doi: 10.1016/j.socscimed.2009.05.019 — View Citation

Ssewamala FM, Ismayilova L, McKay M, Sperber E, Bannon W Jr, Alicea S. Gender and the effects of an economic empowerment program on attitudes toward sexual risk-taking among AIDS-orphaned adolescent youth in Uganda. J Adolesc Health. 2010 Apr;46(4):372-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Savings and asset-accumulation past experience, current savings, and attitudes toward saving baseline, 10-month and 20-month post-intervention No
Secondary Sexual risk taking Sexual risk taking behavior (history and onset of sexual intercourse), Intentions to engage in sexual risk behaviors baseline, 10-month and 20-month post-intervention Yes
Secondary Educational outcomes School enrollment, School attendance, School grades, Educational aspirations baseline, 10-month, and 20-month post-intervention No
Secondary Mental health Self-esteem, depression, hopelessness, helplessness baseline, 10-month and 20-month post-intervention Yes
Secondary Social and family support Emotional support from caregivers, practical assistance, financial assistance and advice/guidance, and family communication baseline, 10-month and 20-month post-intervention No
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