Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2026-01-01 @ 1:21 PM
Study NCT ID:
NCT04231669
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2020-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intervention to Improve Developmental and Health Outcomes for Female Adolescents
Sponsor:
Washington University School of Medicine
Organization:
Study Overview
Official Title:
Intervention to Improve Developmental and Health Outcomes for Female Adolescents
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary goal of this pilot study (R21) is to address the urgent need for theoretically and empirically informed interventions that prevent poor female youth's rural-to-urban migration for child labor in low and middle-income countries. The study will address the following specific aims: Aim 1: Pilot test the (i) feasibility and acceptability of ANZANSI; and (ii) preliminary impact of ANZANSI by comparing the control arm to the treatment arm on specific child development outcomes; Aim 2: Explore multi- level factors (individual, family, and programmatic) impacting participation in and experiences with the ANZANSI.
Detailed Description:
The primary goal of this pilot study (R21) is to address the urgent need for theoretically and empirically informed interventions that prevent poor female youth's rural-to-urban migration for child labor in low and middle-income countries. The International Labor Organization (ILO) estimates that 11% of children (ages 5 to 17) worldwide are child laborers. ILO recently drew attention to migrant child laborers as an underreported, but more vulnerable group to adverse outcomes relative to children working locally. Sub-Saharan Africa (SSA) continues to be the continent with the highest rates of child labor, with Ghana registering one of the highest incidence rates at 22%, including unaccompanied child migrants engaged in labor. Adolescent girls make up the majority of unaccompanied rural-to-urban migrants in search of better economic opportunities. Studies document the myriad of serious threats to health and emotional well-being experienced by female adolescent migrants engaged in child labor. These threats underline the urgent need for theoretically-informed preventive interventions, specifically tailored to address the root causes of female child migrant labor and the needs of girls from economically insecure families and communities. Hence, this application titled ANZANSI Family Program focuses on girls before they drop out of school, but as they begin exhibiting possibility of dropping out. Specifically, ANZANSI is an innovative combination intervention program, combining an evidence-informed family-level economic empowerment (EE) aimed at creating and strengthening financial stability through the use of matched children savings accounts (CSA) and microfinance in poor households with a multiple family group (MFG) intervention addressing family functioning and parental beliefs around gender and child labor/ education. Informed by asset theory, parental ethnotheories framework; and the investigative team's research in SSA on child-wellbeing and poverty, the study uses a cluster randomized control design (N=10 schools; n=100 girls ages 11-14 at risk of dropping out of school and their caregivers), assigned to two study conditions (N= 5 schools; n=50 children at risk of dropping out of school and their caregivers in each condition). The control group will receive bolstered usual care, including books and school lunch and treatment group will receive a combination intervention (Family EE+MFG) called ANZANSI, to address the following specific aims: Aim 1: Pilot test the (i) feasibility and acceptability of ANZANSI; and (ii) preliminary impact of ANZANSI by comparing the control arm to the treatment arm on specific child development outcomes; Aim 2: Explore multi- level factors (individual, family, and programmatic) impacting participation in and experiences with the ANZANSI. This study is aligned with NICHD's mission to support research relevant to the psychological, behavioral, and educational development and health of children worldwide. Ultimately, our findings may guide approaches to address youth's unaccompanied rural-to-urban migration and involvement in child labor in SSA, and the associated negative consequences.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: