Intervention to Improve Developmental and Health Outcomes for Female Adolescents

Independent Child Migration Clinical Trial

Official title:

Intervention to Improve Developmental and Health Outcomes for Female Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04231669
• Other study ID #: R21HD099508
• Status: Completed
• Phase: N/A
• Start date: July 20, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: February 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Independent Child Migration

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Ghana	University of Ghana	Accra

Sponsors (4)

Lead Sponsor	Collaborator
Washington University School of Medicine	BasicNeeds Ghana, BIBIR Ghana, University of Ghana

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intention to Migrate	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).	9 months follow up
Secondary	Attitudes Towards School	Change in attitudes towards school will be measured by School attitude assessment survey. The range is 20 to 100, with higher scores representing a more positive attitude towards school.	baseline, post-test (9 month), 6 month follow-up
Secondary	School Attendance	Change in school attendance will be measured by school attendance reports. Number of missed days will be collected	baseline, post-test (9 month), 6 month follow-up
Secondary	Self-concept	Change in self-concept will be measured by Tennessee Self-Concept Scale Short Form	baseline, post-test (9 months), 6 month follow-up
Secondary	Life Satisfaction	change in life satisfaction will be measured by Multidimensional Student Life Satisfaction Scale	baseline, post-test (9 months), 6 month follow-up
Secondary	Stress	Change in stress levels will be measured by Adolescent Stress Questionnaire	baseline, post-test (9 months), 6 month follow-up
Secondary	Family Relationships	Change in family relations will be measured by Family Environment Scale	baseline, post-test (9 months), 6 month follow-up
Secondary	Family Functioning	Change in family functioning will be measured by Family Assessment Measure	baseline, post-test (9 months), 6 month follow-up
Secondary	Social Support	Change in social support will be measured by Social Support Behavior Scale	baseline, post-test (9 months), 6 month follow-up
Secondary	Perceived Social Support	Change in perceived social support will be measured by Multidimensional Scale of Perceived Social Support	baseline, post-test (9 months), 6 month follow-up
Secondary	Gender Attitudes	Gender attitudes will be measured by attitudes towards women and gender norm attitudes scales	baseline, post-test (9 months), 6 month follow-up
Secondary	Attitude Towards Work	Attitudes towards work will be measured by Attitudes towards youth employment scale	baseline, post-test (9 months), 6 month follow-up
Secondary	Savings	Change in savings will be measured by Bank statements	baseline, post-test (9 months), 6 month follow-up
Secondary	Future Orientation	Change in future orientation will be measured by Thinking about the future measure	baseline, post-test (9 months), 6 month follow-up
Secondary	Self-esteem	Change in self-concept will be measured by Rosenberg self-esteem measure	baseline, post-test (9 months), 6 month follow-up