- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT01180114
Economic Empowerment Program Suubi-Maka (Suubi-Maka)
SUUBI MAKA ("Hope for Families"): A Family-Based Economic Empowerment Model for Orphaned Children in Uganda
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
-
-
-
Rakai, Uganda
- St. Joseph's Matale Parish
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- An AIDS-orphaned child, defined as a child who has lost one or both parents to AIDS;
- Enrolled in the last two years of primary school (even though possibly not attending regularly);
- Between the ages of 11 to 16 years;
- Living within a family.
Exclusion Criteria:
- Any youth below 11 years or above 16 years at the time of enrollment in the study;
- Any youth not enrolled in the final two years of primary school;
- Any youth who does not self-identify as an AIDS-orphan;
- Any youth not being raised primarily within a family context at the start of the study.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
---|---|
Experimentální: SUUBI-MAKA
Involves creating and broadening asset ownership opportunities and life options for children (ages 12 to 15 years) orphaned due to AIDS in Uganda.
|
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.
Ostatní jména:
|
Jiný: Usual Care
No intervention for asset ownership, development of future planning skills, enhancement of mental health and reduction of risk taking behaviors for children orphaned due to AIDS in Uganda.
|
Each child in the control condition receives the usual services for orphaned children (counseling, school lunches, and textbooks).
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Savings and asset-accumulation
Časové okno: 12-month post-intervention
|
Formal and informal savings, wealth/assets (e.g.
livestock, type of housing), and attitudes toward saving
|
12-month post-intervention
|
Educational outcomes
Časové okno: 12-month post-intervention
|
School enrollment, School attendance, School grades, Educational plans and aspirations
|
12-month post-intervention
|
Sexual risk taking
Časové okno: 12-month post-intervention
|
Sexual risk taking behavior (onset of sexual intercourse, unprotected sexual intercourse), Intentions to engage in sexual risk behaviors, HIV knowledge
|
12-month post-intervention
|
Savings and asset-accumulation
Časové okno: 24-month post-intervention
|
Formal and informal savings, wealth/assets (e.g.
livestock, type of housing), and attitudes toward saving
|
24-month post-intervention
|
Educational outcomes
Časové okno: 24-month post-intervention
|
School enrollment, School attendance, School grades, Educational plans and aspirations
|
24-month post-intervention
|
Sexual risk taking
Časové okno: 24-month post-intervention
|
Sexual risk taking behavior (onset of sexual intercourse, unprotected sexual intercourse), Intentions to engage in sexual risk behaviors, HIV knowledge
|
24-month post-intervention
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Mental health
Časové okno: 12-month post-intervention
|
Self-esteem, depression, hopelessness, helplessness
|
12-month post-intervention
|
Social and family support
Časové okno: 12-month post-intervention
|
Child-caregiver relationship, family cohesion, family communication, family support
|
12-month post-intervention
|
Mental health
Časové okno: 24-month post-intervention
|
Self-esteem, depression, hopelessness, and helplessness scales
|
24-month post-intervention
|
Social and family support
Časové okno: 24-month post-intervention
|
Child-caregiver relationship, family cohesion, family communication, family support
|
24-month post-intervention
|
Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Publikace a užitečné odkazy
Obecné publikace
- Jennings L, Ssewamala FM, Nabunya P. Effect of savings-led economic empowerment on HIV preventive practices among orphaned adolescents in rural Uganda: results from the Suubi-Maka randomized experiment. AIDS Care. 2016;28(3):273-82. doi: 10.1080/09540121.2015.1109585. Epub 2015 Nov 7.
- Han CK, Ssewamala FM, Wang JS. Family economic empowerment and mental health among AIDS-affected children living in AIDS-impacted communities: evidence from a randomised evaluation in southwestern Uganda. J Epidemiol Community Health. 2013 Mar;67(3):225-30. doi: 10.1136/jech-2012-201601.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Odhad)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Odhad)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- AAAD2525
- R34MH081763-02 (Grant/smlouva NIH USA)
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .