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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01180114
Other study ID # AAAD2525
Secondary ID R34MH081763-02
Status Completed
Phase N/A
First received July 14, 2010
Last updated November 22, 2012
Start date August 2008
Est. completion date July 2012

Study information

Verified date November 2012
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

The overall goal of SUUBI-MAKA is to further develop and preliminarily examine a family economic empowerment intervention that creates economic opportunities (specifically Children Development Accounts) for families in Uganda who are caring for children orphaned due to the AIDS pandemic, and to lay groundwork for a bigger study with practice and policy implications for Sub-Saharan Africa.


Description:

The study has two specific aims (1) To conduct formative work in order to understand children and families´ ability and interest in participating in a family-level economic empowerment intervention focused on savings and family income generation, and their response to this family-focused economic empowerment approach alongside additional intervention components, including savings for youth education and adult mentorship. (2) Based on formative data (Aim #1), to adapt the intervention and examine issues related to feasibility and preliminary outcome on a small scale in order to prepare for a larger study.

The intervention, SUUBI-MAKA, uses a novel approach by focusing on economic empowerment of families caring for children orphaned due to AIDS. The intervention has three key components (1) it promotes family-level income generating projects (micro-enterprises) which we believe will enhance economic stability, reduce poverty, and enhance protective family processes for youth orphaned by AIDS. (2) It promotes monetary savings for educational opportunities for AIDS-orphaned children. (3) It provides an adult mentor to children. The intervention will be evaluated via a two-group randomized trial. The two groups are SUUBI-MAKA or Usual care for orphaned children. The participating children will be nested within 20 primary schools that will be randomly assigned such that all children from a particular school receive the same intervention.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Both
Age group 11 Years to 16 Years
Eligibility Inclusion Criteria:

1. An AIDS-orphaned child, defined as a child who has lost one or both parents to AIDS;

2. Enrolled in the last two years of primary school (even though possibly not attending regularly);

3. Between the ages of 11 to 16 years;

4. Living within a family.

Exclusion Criteria:

1. Any youth below 11 years or above 16 years at the time of enrollment in the study;

2. Any youth not enrolled in the final two years of primary school;

3. Any youth who does not self-identify as an AIDS-orphan;

4. Any youth not being raised primarily within a family context at the start of the study.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Behavioral:
Suubi-Maka ('Hope for Families')
Each child in the SUUBI-MAKA condition receive the usual care plus asset focused services, specifically: a matched Child Development Account (CDA); twelve 1-2 hour training sessions on career planning, setting short-term and long-term career goals, and how to save money; and monthly mentorship program with young adult peers (undergraduate students) on life options and how to avoid risk behaviors. In addition, participants receive a 2:1 match for their deposits into the account. Further, participants and their adult caregivers receive specific training on microenterprise development and specifically on how to start an income-generating project using up to 50% of the matched savings. The intervention is delivered over a period of 24 months.
Other:
Usual Care
Each child in the control condition receives the usual services for orphaned children (counseling, school lunches, and textbooks).

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Savings and asset-accumulation Formal and informal savings, wealth/assets (e.g. livestock, type of housing), and attitudes toward saving 12-month post-intervention No
Primary Educational outcomes School enrollment, School attendance, School grades, Educational plans and aspirations 12-month post-intervention No
Primary Sexual risk taking Sexual risk taking behavior (onset of sexual intercourse, unprotected sexual intercourse), Intentions to engage in sexual risk behaviors, HIV knowledge 12-month post-intervention No
Primary Savings and asset-accumulation Formal and informal savings, wealth/assets (e.g. livestock, type of housing), and attitudes toward saving 24-month post-intervention No
Primary Educational outcomes School enrollment, School attendance, School grades, Educational plans and aspirations 24-month post-intervention No
Primary Sexual risk taking Sexual risk taking behavior (onset of sexual intercourse, unprotected sexual intercourse), Intentions to engage in sexual risk behaviors, HIV knowledge 24-month post-intervention No
Secondary Mental health Self-esteem, depression, hopelessness, helplessness 12-month post-intervention Yes
Secondary Social and family support Child-caregiver relationship, family cohesion, family communication, family support 12-month post-intervention No
Secondary Mental health Self-esteem, depression, hopelessness, and helplessness scales 24-month post-intervention Yes
Secondary Social and family support Child-caregiver relationship, family cohesion, family communication, family support 24-month post-intervention No
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