Intervention to Improve Developmental and Health Outcomes for Female Adolescents

NCT ID: NCT04231669

Last Updated: 2026-01-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-20
• Study Completion Date: 2022-06-30

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.

Conditions

Independent Child Migration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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).

Group Type: EXPERIMENTAL

Anzansi Family Program

Intervention Type: BEHAVIORAL

the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component:

MFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being. Both adolecsnt girls and their caregivers will receive the intervention.

Interventions

Anzansi Family Program

the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component:

MFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being. Both adolecsnt girls and their caregivers will receive the intervention.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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).

• 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.

• Minimum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Ghana

OTHER

Sponsor Role: collaborator

BasicNeeds Ghana

OTHER

Sponsor Role: collaborator

BIBIR Ghana

OTHER

Sponsor Role: collaborator

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Ghana

Accra, , Ghana

Countries

Ghana

References

Sensoy Bahar O, Ssewamala FM, Ibrahim A, Boateng A, Nabunya P, Neilands TB, Asampong E, McKay MM. Anzansi family program: a study protocol for a combination intervention addressing developmental and health outcomes for adolescent girls at risk of unaccompanied migration. Pilot Feasibility Stud. 2020 Dec 7;6(1):190. doi: 10.1186/s40814-020-00737-4.

Reference Type: DERIVED

PMID: 33372647 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

R21HD099508

Identifier Type: NIH

Identifier Source: org_study_id

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