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Testar o Impacto da Intervenção Baseada na Família para Melhorar os Resultados de Desenvolvimento e Saúde em Adolescentes do Sexo Feminino

30 de setembro de 2026 atualizado por: New York University

Testar o Impacto da Intervenção Baseada na Família para Melhorar os Resultados de Desenvolvimento e Saúde de Adolescentes do Sexo Feminino

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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Tipo de estudo

Intervencional

Inscrição (Estimado)

1920

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Ozge Sensoy Bahar
  • Número de telefone: 617 610 6814
  • E-mail: osb208@nyu.edu

Locais de estudo

      • Tamale, Gana
        • Recrutamento
        • University of Ghana
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

11 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Sem intervenção: 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

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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
overall health
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Self-concept
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Colaboradores

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

7 de abril de 2026

Conclusão Primária (Estimado)

15 de agosto de 2030

Conclusão do estudo (Estimado)

15 de agosto de 2030

Datas de inscrição no estudo

Enviado pela primeira vez

6 de dezembro de 2025

Enviado pela primeira vez que atendeu aos critérios de CQ

6 de dezembro de 2025

Primeira postagem (Real)

12 de dezembro de 2025

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de outubro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

30 de setembro de 2026

Última verificação

1 de abril de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • R01HD116780 (Concessão/Contrato do NIH dos EUA)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano 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.

Prazo de Compartilhamento de IPD

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

Tipo de informação de suporte de compartilhamento de IPD

  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .