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Unaccompanied MigrationNCT07278934

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

A study testing ANZANSI Family Program in people with Unaccompanied Migration, run by New York University at 1 site in Ghana.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 11 years and olderHealthy volunteers can take part
Conditions the study is for
Unaccompanied Migration
What is being tested?
ANZANSI Family Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,920 participants
Where
1 siteGhana
Study dates
7 Apr 2026to 15 Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Age 18 or older
  • Self-identified as primary caregiver of the adolescent girl
  • Capable of providing informed consent.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ozge Sensoy Bahar contact

617 610 6814

osb208@nyu.edu

Ghana1 site, 1 recruiting
  • University of Ghana

    Tamale

    Adolphina Addo-Lartey, +233 26 145 8709, AAddo-Lartey@ug.edu.gh

    Recruiting

Other trials in Ghana

About this study

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.

Being tested
ANZANSI Family Program

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ANZANSI Family ProgramBehavioural

    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.

Study groups in NCT07278934
Study groupRoleWhat they receive
Bolstered careNo interventionFemale 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 ProgramExperimentalIn 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
Receives: Behavioral: ANZANSI Family Program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. overall health

    Change in health will be measured using the 5-item physical health subscale of the KIDSCREEN-52 Health Questionnaire for Children and Young People. The items are rated on a 1 to 5 Likert scale, with higher scores indicating better physical health. The theoretical range is from 5 to 25.

    Measured: baseline, 12 months, 24 months, 36 months

  2. Nutrition

    Change in nutrition is measured using the 29-item Diet Quality Questionnaire-Ghana, mapping onto 29 food groups. Each item is rated yes/no. DQQ data collection uses the closed-ended, sentinel foods list-based method and captures food and drink consumption from the previous day and night.

    Measured: baseline, 12 month, 24 month, 36 month

  3. mental health

    Change in mental health will be measured using Patient Health Questionnaire Depression Scale (PHQ-8). Each of the 8 items is rated from 0 ("not at all") to 3 ("nearly every day"). The theoretical range is from 0 to 24, with higher scores representing more severe depression. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.

    Measured: baseline, 12 month, 24 month, 36 month

  4. Risk-taking

    Change in risk-taking will be measured using subsections from the Global School-based Student Health Survey (GSHS). GSHS measures behavioural risk factors and protective factors. For this study, the measure includes questions about tobacco and alcohol use as well as sexual risk-taking.

    Measured: baseline, 12 month, 24 month, 36 month

Secondary outcomes (18)
  1. Self-concept

    Change in self-concept will be measured by the Tennessee Self-Concept Scale Short Form. The 20-item short version of the original 100-item TSCS scale assesses adolescents' perception of self-identity and self-satisfaction. The items are rated on a 5-point Likert scale ranging from 1 = always false to 5 = always true. The theoretical range for the TSCS is 20-100, with higher scores representing a more positive self-concept.

    Measured: baseline, 12 months, 24 months, 36 months

  2. Unaccompanied migration

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

    Measured: 12 months, 24 months, 36 months

  3. self-esteem

    Change in self-esteem will be measured using Rosenberg's self-esteem scale (RSES). The scale comprises 10 statements about general feelings of self-worth or self-acceptance rated on a 4-point Likert scale response option (strongly agree to strongly disagree, with 4 = strongly agree, 3 = agree, 2 = disagree, 1 = strongly disagree). The items are scored on a theoretical range of 10-40 and summed, with higher scores representing higher self-esteem.

    Measured: baseline, 12 months, 24 months, 36 months

  4. life satisfaction

    Change in life satisfaction will be measured using the multi-dimensional student life satisfaction scale (MSLSS). The scale includes 40 items assessing life satisfaction on 5 specific aspects while maintaining an overall life satisfaction score. Responses are rated on a 6-point Likert scale with 1 = strongly disagree, 2 = moderately disagree, 3 = slightly disagree, 4 = slightly agree, 5 = moderately agree, and 6 = strongly agree (theoretical range 40-240). Higher values represent higher satisfaction in student life.

    Measured: baseline, 12 months, 24 months, 36 months

  5. school attendance

    Change in school attendance for the past academic year will be measured using school records.

    Measured: baseline, 12 months, 24 months, 36 months

  6. grade progress

    Grade progress will be measured using a three-response question (0= enrolled in expected grade, 1=grade repetition, 2=dropout)

    Measured: baseline, 12 months, 24 months, 36 months

  7. attitudes toward 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. Attitudes toward school were assessed using the school attitude assessment survey (SAAS; McCoach, 2002). The survey consists of 20 items rated on a 5-point Likert scale (1 = not at all, 2 = a little bit, 3 = pretty well, 4 = well, and 5 = very well). The scale measures aspects of students' lives that predict their academic achievement, including peer attitudes, attitudes toward school, self-motivation, and self-regulation. Higher values representing higher positive attitudes toward school.

    Measured: baseline, 12 months, 24 months, 36 months

  8. social support

    change in social support will be measured using the social support behavior scale. The SS-B measure consists of 45 items designed to tap five modes of support: emotional support, socializing, practical assistance, financial assistance, and advice/guidance. The Likert scale is from 1=strongly disagree to 5=strongly agree. The theoretical range is 45-225, with higher scores indicating higher social support.

    Measured: baseline, 12 months, 24 months, 36 months

  9. perceived social support

    Change in perceived social support will be measured by the Multidimensional Scale of Perceived Social Support. The MSPSS is a self-report measure to assess participants' social support. The 12-item scale had statements such as, "there is a special person who is around when I am in need," rated on a 5-point Likert scale ranging from strongly agree to strongly disagree, with 5=strongly agree, 4=agree, 3=neutral, 2=disagree, 1=strongly disagree. The theoretical range is 12-60, with higher scores indicating greater social support.

    Measured: baseline, 12 months, 24 months, 36 months

  10. family cohesion

    change in family cohesion will be measured by a 7-item measure adapted from Family environment scale and family assessment measure. The items measure the degree of commitment, help and support family members provide for one another. Participants are asked to rate how often each item occurred in their family using a 5-point scale (with 1 = 'never' and 5 = 'always'). Items include 'Do your family members ask each other for help before asking nonfamily members for help?', and 'Do you listen to what other family members have to say, even when you disagree?' Theoretical range is 7 to 35, with higher scores indicating higher levels of family cohesion.

    Measured: baseline, 12 months, 24 months, 36 months

  11. parenting stress

    change in parenting stress will be measured by parental stress scale (PSS) developed by Berry and Jones (1995). The 18 item scale is scored with a 5-point likert scale, 1 = Strongly disagree 2 = Disagree 3 = Undecided 4 = Agree 5 = Strongly agree (theoretical range 18-80). Items represent positive (e.g. emotional benefits, personal development) and negative (demands on resources, restrictions) themes of parenthood. Lower scores represent lower levels of parenting stress.

    Measured: baseline, 12 months, 24 months, 36 months

  12. Intention to migrate

    change in intention to migrate will be measured by one item: 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).

    Measured: baseline, 12 months, 24 months, 36 months

  13. gender norms

    change in gender norms will be measured by the 10-item scale adapted from the Gender Norm Attitudes Scale (Waszak et al., 2001), which measures participants' understanding of the appropriateness of behaviors as they relate to being female and male. The items in the scale encompass aspects related to educational performance, future expectations for both genders, family support, encouragement, decision-making, and involvement in intimate relationships and behaviors. The scale items featuredbinary responses (Agree = 1 and Disagree = 0; theoretical range 0-10). Higher scores denote more egalitarian gender norms and beliefs.

    Measured: baseline, 12 months, 24 months, 36 months

  14. future orientation

    change in future orientation will be measured by two items evaluating adolescents' expectations and optimism regarding their educational goals. The first item asks participants, How sure are you that you will achieve your educational plans? with response options ranging from 1 = Not at all sure to 5 = Extremely sure. The second item asks, How hopeful are you that you will achieve your educational plans? with parallel response options ranging from 1 = Not at all hopeful to 5 = Extremely hopeful (theoretical range 2-10). Higher scores indicate a more positive future orientation

    Measured: baseline, 12 months, 24 months, 36 months

  15. confidence in saving

    change in confidence in saving will be measured by the confidence in saving survey that includes 5 items that assess participant's confidence in saving and saving-related behaviors. The survey uses a 5-point likert scale: 5= extremely confident, 4= very confident, 3= somewhat confident, 2= not very confident, or 1= not confident at all (theoretical range 5-25). Higher scores indicate higher confidence

    Measured: baseline, 12 months, 24 months, 36 months

  16. importance of saving

    change in importance of saving will be measured by the importance of saving survey that includes 5 items that assess importance of saving for participants. The survey uses a 5-point Likert scale: 5= extremely important, 4= very important, 3= somewhat important, 2= not very important, or 1= not important at all (theoretical range 5-25). Higher scores indicate higher importance of saving for participants.

    Measured: baseline, 12 months, 24 months, 36 months

  17. saving

    change in savings overtime in the intervention group will be measured by monthly bank statements

    Measured: 12 months, 24 months, 36 months

  18. child-caregiver relationship

    The perceived child-caregiver relationship scale is adapted from the Family Assessment measure and assess relationships on two dimensions: (1) acceptance and warmth - the extent to which the caregiver perceives as involved in their child's life; and (2) psychological autonomy - the extent to which the caregiver employs a non-coercive, democratic discipline and encourages the child to express individuality within the family. Participants are asked to rate the adults they live with, on each of the 17 items (range: 17-85), on a 5-point scale (1 = 'never' and 5 = 'always'). Sample items include: "Can you count on your parents to help her if she has a problem?" and "Do your parents keep challenging you to do the best in whatever you do?" Higher scores indicatw a more positive child-caregiver relationship.

    Measured: baseline, 12 months, 24 months, 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start7 Apr 2026
  3. Primary completion15 Aug 2030 (estimated)
  4. Study completion15 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,920 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07278934
Sponsor's protocol ID
R01HD116780
Status last verified
Apr 2026
First submitted
6 Dec 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The study team will use the NICHD Data and Specimen Hub (DASH) to deposit the data. DASH is a centralized resource that allows researchers to share and access de-identified data from studies fundedby NICHD.

Publications

  • Sensoy Bahar O, Addo-Lartey A, Ibrahim A, Ssewamala FM, Neilands TB, Tozan Y, Boateng A, Byansi W, Dahlen A, McKay MM. Testing the impact of family-based intervention to improve developmental and health outcomes for female adolescents: study protocol for a cluster-randomized clinical trial in Ghana. BMC Public Health. 2026 Aug 19;26(1):2671. doi: 10.1186/s12889-026-28823-x.

    PubMed 42786450

Questions about this trial

What is this clinical trial studying?

A study testing ANZANSI Family Program in people with Unaccompanied Migration, run by New York University at 1 site in Ghana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ozge Sensoy Bahar (617 610 6814, osb208@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

overall health (time frame: baseline, 12 months, 24 months, 36 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07278934, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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