Clinical trial NCT04231669: Intervention to Improve Developmental and Health Outcomes for Female Adolescents
Official title: Intervention to Improve Developmental and Health Outcomes for Female Adolescents
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Independent Child Migration
Keywords: child migration
child labor
sub-Saharan Africa
female adolescents
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: University of Ghana
name: BasicNeeds Ghana
name: BIBIR Ghana
First posted: 2020-01-18
Enrollment: 200
Sex: ALL
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Intention to Migrate
timeFrame: post-test (9 months)
Secondary outcomes:
measure: Attitudes Towards School
timeFrame: baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)
measure: School Attendance
timeFrame: baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)
measure: Self-concept
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Life Satisfaction
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Stress
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Family Relationships
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Family Functioning
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Social Support
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Perceived Social Support
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Gender Attitudes
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Attitude Towards Work
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Savings
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Future Orientation
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
measure: Self-esteem
timeFrame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: University of Ghana
Study officials:
References:
citation: 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.