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测试基于家庭的干预对改善女性青少年发育和健康结果的影响

2026年9月30日 更新者: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.

研究概览

地位

招聘中

研究类型

介入性

注册 (估计的)

1920

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名:Ozge Sensoy Bahar
  • 电话号码:617 610 6814
  • 邮箱:osb208@nyu.edu

学习地点

      • Tamale、加纳
        • 招聘中
        • University of Ghana
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

11年 及以上 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预: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)

实验性的: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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
overall health
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Self-concept
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月7日

初级完成 (估计的)

2030年8月15日

研究完成 (估计的)

2030年8月15日

研究注册日期

首次提交

2025年12月6日

首先提交符合 QC 标准的

2025年12月6日

首次发布 (实际的)

2025年12月12日

研究记录更新

最后更新发布 (实际的)

2026年10月5日

上次提交的符合 QC 标准的更新

2026年9月30日

最后验证

2026年4月1日

更多信息

与本研究相关的术语

其他研究编号

  • R01HD116780 (美国 NIH 拨款/合同)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

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.

IPD 共享时间框架

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

IPD 共享支持信息类型

  • 树液
  • 国际碳纤维联合会

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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