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Évaluation de l'impact d'une intervention familiale pour améliorer les résultats développementaux et de santé chez les adolescentes

30 septembre 2026 mis à jour par: New York University

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.

Aperçu de l'étude

Statut

Recrutement

Type d'étude

Interventionnel

Inscription (Estimé)

1920

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: Ozge Sensoy Bahar
  • Numéro de téléphone: 617 610 6814
  • E-mail: osb208@nyu.edu

Lieux d'étude

      • Tamale, Ghana
        • Recrutement
        • University of Ghana
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

11 ans et plus (Enfant, Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Tout

La description

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.

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: La prévention
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Aucune 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)

Expérimental: 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

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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
overall health
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
Nutrition
Délai: baseline, 12 month, 24 month, 36 month

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.

baseline, 12 month, 24 month, 36 month
mental health
Délai: baseline, 12 month, 24 month, 36 month

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.

baseline, 12 month, 24 month, 36 month
Risk-taking
Délai: baseline, 12 month, 24 month, 36 month

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.

baseline, 12 month, 24 month, 36 month

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Self-concept
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
Unaccompanied migration
Délai: 12 months, 24 months, 36 months

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
self-esteem
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
life satisfaction
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
school attendance
Délai: baseline, 12 months, 24 months, 36 months

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

baseline, 12 months, 24 months, 36 months
grade progress
Délai: baseline, 12 months, 24 months, 36 months

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

baseline, 12 months, 24 months, 36 months
attitudes toward school
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
social support
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
perceived social support
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
family cohesion
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
parenting stress
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
Intention to migrate
Délai: baseline, 12 months, 24 months, 36 months

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).

baseline, 12 months, 24 months, 36 months
gender norms
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
future orientation
Délai: baseline, 12 months, 24 months, 36 months

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

baseline, 12 months, 24 months, 36 months
confidence in saving
Délai: baseline, 12 months, 24 months, 36 months

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

baseline, 12 months, 24 months, 36 months
importance of saving
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months
saving
Délai: 12 months, 24 months, 36 months

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

12 months, 24 months, 36 months
child-caregiver relationship
Délai: baseline, 12 months, 24 months, 36 months

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.

baseline, 12 months, 24 months, 36 months

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

7 avril 2026

Achèvement primaire (Estimé)

15 août 2030

Achèvement de l'étude (Estimé)

15 août 2030

Dates d'inscription aux études

Première soumission

6 décembre 2025

Première soumission répondant aux critères de contrôle qualité

6 décembre 2025

Première publication (Réel)

12 décembre 2025

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 octobre 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

30 septembre 2026

Dernière vérification

1 avril 2026

Plus d'information

Termes liés à cette étude

Autres numéros d'identification d'étude

  • R01HD116780 (Subvention/contrat des NIH des États-Unis)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

OUI

Description du régime IPD

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.

Délai de partage IPD

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

Type d'informations de prise en charge du partage d'IPD

  • SÈVE
  • CIF

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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