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Clinical Trials/NCT04231669
NCT04231669
Completed
N/A

Intervention to Improve Developmental and Health Outcomes for Female Adolescents

Washington University School of Medicine1 site in 1 country200 target enrollmentJuly 20, 2020

Overview

Phase
N/A
Intervention
Control: bolstered care
Conditions
Independent Child Migration
Sponsor
Washington University School of Medicine
Enrollment
200
Locations
1
Primary Endpoint
Intention to Migrate
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 20, 2020
End Date
June 30, 2022
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Adolescent girls' inclusion criteria are:
  • Enrolled in school and living within a family (defined broadly -not necessarily biological parents)
  • Ages 11 to 14
  • Capable of giving assent
  • Skipping school in the past academic term (with at least 10% of unexcused absences).
  • The caregiver inclusion criteria are:
  • Self-identified as primary caregiver of the adolescent girl
  • Capable of providing informed consent.

Exclusion Criteria

  • Participants (girls and caregivers) that do not meet the criteria or exhibit a lack of understanding of the study procedures and hence not able to provide informed consent will be excluded.

Arms & Interventions

Control: bolstered care

Female adolescents in the bolstered care will receive services/education as usual in their respective schools. The usual care will be bolstered by providing school notebooks and lunch in the control arm (bolstered care will also be provided to treatment arm). Primary school education is universal and free in Ghana. Yet notebooks and lunch are costly expenses for families that create a barrier to school attendance. Hence, these will be provided to participants in all study schools.

Anzansi Family Program

In addition to bolstered care, participants(adolescent girls and caregivers) in this arm will receive the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG).

Intervention: Anzansi Family Program

Outcomes

Primary Outcomes

Intention to Migrate

Time Frame: Baseline, post-test (9 months), 6-months follow-up

Change in intention to migrate will be measured by one question: How likely do you (the adolescent girl) see yourself migrating? The question uses a likert scale ranging from 1 (very unlikely) to 5 (very likely).

Secondary Outcomes

  • School Attendance(baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion))
  • Perceived Social Support(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • Gender Attitudes(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • Self-concept(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • Social Support(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • Attitudes Towards School(baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion))
  • Future Orientation(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • Multidimensional Student Life Satisfaction(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • The Adolescent Stress Questionnaire (ASQ)(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • Family Cohesion(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • Child-caregiver Relationship(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • Savings(post-test (9 months))
  • Self-Esteem(baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion))
  • Emotional Self-efficacy(baseline, post-test (9 months), 6-month follow-up (15 months))
  • Social Self-efficacy(baseline, post-test (9 months), 6-month follow-up (15 months))

Study Sites (1)

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