ClinicalTrials.gg
RecruitingNCT07278934Updated Oct 5, 2026

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

An interventional study of ANZANSI Family Program in Unaccompanied Migration, sponsored by New York University. Recruiting at 1 site in Ghana. Open to participants aged 11 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by New York University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Started Apr 2026; still recruiting 7 months later.
Updated Oct 5, 2026Primary outcomes revisedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
1,920
Allocation
Randomized
Ages
11 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Unaccompanied Migration
03

In context

Lead sponsor

New York University is the lead sponsor of 123 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
11 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

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 will be excluded.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,920 participants (estimated)

Study arms

  • No intervention
    Bolstered care

    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)

  • Experimental
    ANZANSI Family Program

    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

  • BehavioralANZANSI 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 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.

06

What researchers measure

Primary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: baseline, 12 month, 24 month, 36 month

Secondary outcomes

  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.

    Time frame: 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

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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)

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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).

    Time frame: 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.

    Time frame: 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

    Time frame: 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

    Time frame: 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.

    Time frame: baseline, 12 months, 24 months, 36 months

  17. saving

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

    Time frame: 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.

    Time frame: baseline, 12 months, 24 months, 36 months

07

Study locations

1 of 1 sites recruiting
  • University of Ghana
    Tamale, Ghana
    Recruiting
08

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: 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.

Supporting information: Statistical analysis plan, Informed consent form

Time frame: Data will become public after results on the study outcomes are analyzed and published.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Apr 2026 (actual). Primary completion is estimated for Aug 2030, 52 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 6, 2025
First posted
Dec 12, 2025
StartActual
Apr 7, 2026
Primary completionEst.
Aug 15, 2030
CompletionEst.
Aug 15, 2030
Last update
Oct 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary outcomes
4 added, 1 removed
What changed in the outcomes
  • Addedoverall healthTime frame: baseline, 12 months, 24 months, 36 months
  • AddedNutritionTime frame: baseline, 12 month, 24 month, 36 month
  • Addedmental healthTime frame: baseline, 12 month, 24 month, 36 month
  • AddedRisk-takingTime frame: baseline, 12 month, 24 month, 36 month
  • RemovedUnaccompanied migrationTime frame: 12 months, 24 months, 36 months
Oct 5, 2026
Publications
1 publication citing this study linked from PubMed, e.g. PubMed 42786450 ↗
Oct 5, 2026
Secondary outcomes
1 added, 3 description edited
What changed in the outcomes
  • AddedUnaccompanied migrationTime frame: 12 months, 24 months, 36 months
  • DescriptionSelf-concept: how it is measured was reworded
  • Descriptionlife satisfaction: how it is measured was reworded
  • Descriptionself-esteem: how it is measured was reworded
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    Publications 1 publication citing this study linked from PubMed, e.g. PubMed 42786450 ↗
    Primary outcomes 4 added, 1 removed
    What changed in the outcomes
    • Addedoverall healthTime frame: baseline, 12 months, 24 months, 36 months
    • AddedNutritionTime frame: baseline, 12 month, 24 month, 36 month
    • Addedmental healthTime frame: baseline, 12 month, 24 month, 36 month
    • AddedRisk-takingTime frame: baseline, 12 month, 24 month, 36 month
    • RemovedUnaccompanied migrationTime frame: 12 months, 24 months, 36 months
    Secondary outcomes 1 added, 3 description edited
    What changed in the outcomes
    • AddedUnaccompanied migrationTime frame: 12 months, 24 months, 36 months
    • DescriptionSelf-concept: how it is measured was reworded
    • Descriptionlife satisfaction: how it is measured was reworded
    • Descriptionself-esteem: how it is measured was reworded
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07278934
Collaborators
University of Ghana, Washington University School of Medicine
Responsible party
Sponsor
First posted
Dec 12, 2025
Start date
Apr 7, 2026
Primary completion
Aug 15, 2030 (estimated)
Completion
Aug 15, 2030 (estimated)
Last update
Oct 5, 2026

Study contacts

Ozge Sensoy Bahar
Contact
osb208@nyu.edu
617 610 6814

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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