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

NCT07278934 | Recruiting

• 1 other identifier: R01HD116780
• Study Type: interventional
• Target: 1,920
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unaccompanied Migration

Outcome Measures

Primary Outcomes (1)

• Unaccompanied migration

  Change in the incidence of unaccompanied migration will be measured by a two-item scale (yes/no) and school records

  12 months, 24 months, 36 months

Secondary Outcomes (17)

• Self-concept

  baseline, 12 months, 24 months, 36 months

• self-esteem

  baseline, 12 months, 24 months, 36 months

• life satisfaction

  baseline, 12 months, 24 months, 36 months

• school attendance

  baseline, 12 months, 24 months, 36 months

• grade progress

  baseline, 12 months, 24 months, 36 months

Study Arms (2)

Bolstered care

NO INTERVENTION

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 supplies (e.g., textbooks, notebooks)

ANZANSI Family Program

EXPERIMENTAL

In addition to bolstered care, participants in this arm will receive the ANZANSI intervention comprised of family economic empowerment (FEE) intervention and multiple family group (MFG) intervention. FEE includes: 1) Financial Literacy Training; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion component

Behavioral: ANZANSI Family Program

Interventions

ANZANSI Family Program BEHAVIORAL

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 on IGAs and expected to use part of their matched savings to start an IGA. Multiple Family Groups. The manualized 16-session intervention is organized around 4Rs (Rules, Responsibility, Relationships, and Respectful Communication) and 2Ss (Stress and Social Support). Children and caregivers complete activities together or split to reconvene later for discussing as a larger group. Each group involves 7 to 10 families, with at least two generations of a family present in each session.

ANZANSI Family Program

Eligibility Criteria

• Age: 11 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• New York University: lead
• University of Ghana: collaborator
• Washington University School of Medicine: collaborator

Study Sites (1)

University of Ghana

Tamale, Ghana

RECRUITING

Central Study Contacts

Ozge Sensoy Bahar

CONTACT

617 610 6814; osb208@nyu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: December 12, 2025
• Study Start: April 7, 2026
• Primary Completion (Estimated): August 15, 2030
• Study Completion (Estimated): August 15, 2030
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: Data will become public after results on the study outcomes are analyzed and published.

Locations

GH (1)