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Recruiting NCT07278934

Testing the Impact of Family-Based Intervention to Improve Developmental and Health Outcomes for Female Adolescents

No phase Interventional Unaccompanied Migration

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ANZANSI Family Program.
Who it may be relevant to
Registry conditions: Unaccompanied Migration. Basic parameters: from 11 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Ghana
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

This study seeks to address the urgent need for theoretically and empirically informed interventions that would address the increasing numbers of unaccompanied minors migrating from rural to urban centers in developing countries for better economic opportunities. This process often results in hazardous child labor defined as work that is mentally, physically, socially or morally dangerous and harmful; interfering with schooling and health and mental health functioning, and leading to several other disproportionate risks. Unaccompanied migrant child laborers' vulnerability is further intensified by the lack of parental protection and community belonging in the host urban center. The International Labor Organization (ILO) estimates that 9.6% of children (ages 5 to 17) across the globe are child laborers and draws attention to migrant child laborers as an underreported and highly vulnerable group, a significant portion of which are female with no education. Poverty has been identified as the main driver of child labor, with family context also being a critical contributing factor. Sub-Saharan Africa (SSA) has the highest rates of child labor (24%), with Ghana -the focus of this study- registering one of the highest child labor prevalence at 22%, including unaccompanied child migrant laborers. In Ghana, unaccompanied adolescent girls migrate from the Northern region to urban centers in the south to work in the informal economy. Load carrying is the most common type of labor for this population and exposes migrant girls to multiple developmental and health risks. Building on the recently concluded R21 study (with 97 adolescent girls aged 11 to 14 years and their caregivers) that showed high feasibility and acceptability, and promising preliminary impact of the ANZANSI (resilience in Dagbani -local language) combination intervention in the same region, we propose to test its effectiveness in a larger two-arm cluster randomized clinical trial among 960 adolescent girls (age 11 to 14 years) at risk of school dropout nested within 32 public junior high schools in the Northern region of Ghana and their caregivers. The schools will be randomly assigned to one of two study conditions: 1) ANZANSI (FEE+MFG) and 2) bolstered usual care. The intervention will be delivered for 12 months, with assessments conducted at baseline and at 12-, 24-, and 36-month follow-ups post-intervention initiation. The study specific aims are: Aim 1: Examine the short- and medium-term impacts of ANZANSI intervention on the incidence of unaccompanied migration for child labor (primary outcome), and academic progress and psychosocial outcomes (secondary); Aim 2: Examine the impact of the ANZANSI intervention on potential mechanisms of change at the individual, family, and community levels; Aim 3: Evaluate the cost and cost-effectiveness of each intervention condition; and Aim 4: Qualitatively examine participants, facilitators, and school leadership's experiences with the intervention.

Interventions

  • Behavioral ANZANSI Family Program
    Family Economic Empowerment: 1) Financial literacy training: Four 1-2 hour workshop sessions focused on financial literacy will be delivered. 2) CDA. Each participant receives a CDA, a matched savings account. Participants' family members, relatives, or friends are allowed and encouraged to contribute towards the CDA. The account is then matched with money from the project. The match cap is an equivalent of US$10 per month; 3) The family income-generating activity (IGA): Participants are trained

Primary outcome measures

  • Unaccompanied migration [Time frame: 12 months, 24 months, 36 months]
Secondary outcome measures (12)
  • Self-concept [Time frame: baseline, 12 months, 24 months, 36 months]
  • self-esteem [Time frame: baseline, 12 months, 24 months, 36 months]
  • life satisfaction [Time frame: baseline, 12 months, 24 months, 36 months]
  • school attendance [Time frame: baseline, 12 months, 24 months, 36 months]
  • grade progress [Time frame: baseline, 12 months, 24 months, 36 months]
  • attitudes toward school [Time frame: baseline, 12 months, 24 months, 36 months]
  • social support [Time frame: baseline, 12 months, 24 months, 36 months]
  • perceived social support [Time frame: baseline, 12 months, 24 months, 36 months]
  • family cohesion [Time frame: baseline, 12 months, 24 months, 36 months]
  • parenting stress [Time frame: baseline, 12 months, 24 months, 36 months]
  • Intention to migrate [Time frame: baseline, 12 months, 24 months, 36 months]
  • gender norms [Time frame: baseline, 12 months, 24 months, 36 months]

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
  • Skipping school in the past academic term (with at least 10% of unexcused absences).
  • Capable of giving assent

The caregiver inclusion criteria

  • Age 18 or older
  • Self-identified as primary caregiver of the adolescent girl
  • Capable of providing informed consent.

Exclusion criteria

\- Participants 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Prevention

Study locations

Ghana · 1 center
  • University of Ghana — Tamale

Identifiers

NCT: NCT07278934 · R01HD116780

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗