Skip to content

Intervention to Improve Developmental and Health Outcomes for Female Adolescents

Intervention to Improve Developmental and Health Outcomes for Female Adolescents

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04231669
Enrollment
200
Registered
2020-01-18
Start date
2020-07-20
Completion date
2022-06-30
Last updated
2026-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Independent Child Migration

Keywords

child migration, child labor, sub-Saharan Africa, female adolescents

Brief summary

The primary goal of this pilot study (R21) is to address the urgent need for theoretically and empirically informed interventions that prevent poor female youth's rural-to-urban migration for child labor in low and middle-income countries. The study will address the following specific aims: Aim 1: Pilot test the (i) feasibility and acceptability of ANZANSI; and (ii) preliminary impact of ANZANSI by comparing the control arm to the treatment arm on specific child development outcomes; Aim 2: Explore multi- level factors (individual, family, and programmatic) impacting participation in and experiences with the ANZANSI.

Detailed description

The primary goal of this pilot study (R21) is to address the urgent need for theoretically and empirically informed interventions that prevent poor female youth's rural-to-urban migration for child labor in low and middle-income countries. The International Labor Organization (ILO) estimates that 11% of children (ages 5 to 17) worldwide are child laborers. ILO recently drew attention to migrant child laborers as an underreported, but more vulnerable group to adverse outcomes relative to children working locally. Sub-Saharan Africa (SSA) continues to be the continent with the highest rates of child labor, with Ghana registering one of the highest incidence rates at 22%, including unaccompanied child migrants engaged in labor. Adolescent girls make up the majority of unaccompanied rural-to-urban migrants in search of better economic opportunities. Studies document the myriad of serious threats to health and emotional well-being experienced by female adolescent migrants engaged in child labor. These threats underline the urgent need for theoretically-informed preventive interventions, specifically tailored to address the root causes of female child migrant labor and the needs of girls from economically insecure families and communities. Hence, this application titled ANZANSI Family Program focuses on girls before they drop out of school, but as they begin exhibiting possibility of dropping out. Specifically, ANZANSI is an innovative combination intervention program, combining an evidence-informed family-level economic empowerment (EE) aimed at creating and strengthening financial stability through the use of matched children savings accounts (CSA) and microfinance in poor households with a multiple family group (MFG) intervention addressing family functioning and parental beliefs around gender and child labor/ education. Informed by asset theory, parental ethnotheories framework; and the investigative team's research in SSA on child-wellbeing and poverty, the study uses a cluster randomized control design (N=10 schools; n=100 girls ages 11-14 at risk of dropping out of school and their caregivers), assigned to two study conditions (N= 5 schools; n=50 children at risk of dropping out of school and their caregivers in each condition). The control group will receive bolstered usual care, including books and school lunch and treatment group will receive a combination intervention (Family EE+MFG) called ANZANSI, to address the following specific aims: Aim 1: Pilot test the (i) feasibility and acceptability of ANZANSI; and (ii) preliminary impact of ANZANSI by comparing the control arm to the treatment arm on specific child development outcomes; Aim 2: Explore multi- level factors (individual, family, and programmatic) impacting participation in and experiences with the ANZANSI. This study is aligned with NICHD's mission to support research relevant to the psychological, behavioral, and educational development and health of children worldwide. Ultimately, our findings may guide approaches to address youth's unaccompanied rural-to-urban migration and involvement in child labor in SSA, and the associated negative consequences.

Interventions

the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component: MFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being. Both adolecsnt girls and their caregivers will receive the intervention.

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
University of Ghana
CollaboratorOTHER
BasicNeeds Ghana
CollaboratorOTHER
BIBIR Ghana
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
11 Years to No maximum
Healthy volunteers
Yes

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 * Capable of giving assent * Skipping school in the past academic term (with at least 10% of unexcused absences). The caregiver inclusion criteria are: * Self-identified as primary caregiver of the adolescent girl * Capable of providing informed consent.

Exclusion criteria

* Participants (girls and caregivers) 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.

Design outcomes

Primary

MeasureTime frameDescription
Intention to MigrateBaseline, post-test (9 months), 6-months follow-upChange in intention to migrate will be measured by one question: 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).

Secondary

MeasureTime frameDescription
Attitudes Towards Schoolbaseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)Change in attitudes towards school were measured by 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; range 20 to 100). The scale measures aspects of students' lives that predict their academic achievement, including peer attitudes, attitudes toward school, self-motivation, and self-regulation. The items were coded and summed, with the higher values representing higher positive attitudes toward school (Cronbach's alpha = 0.92).
School Attendancebaseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)Change in school attendance will be measured by school attendance reports. Number of missed days will be collected
Self-conceptbaseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)Change in self-concept was measured by the Tennessee Self-Concept Scale Short Form (TSCS). 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.
Multidimensional Student Life Satisfactionbaseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)change in life satisfaction was measured by Multidimensional Student Life Satisfaction Scale (MSLSS) (Wilson, 2015). The scale includes 40 items assessing life satisfaction on 5 specific aspects while maintaining an overall life satisfaction score (Huebner et al., 1998). 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). To avoid the potential for type I error, the total score was summed up and used in the analysis, with the higher values representing higher satisfaction in student life.
The Adolescent Stress Questionnaire (ASQ)baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)Change in stress levels was measured by the Adolescent Stress Questionnaire (ASQ) (Byrne et al., 2007). The ASQ consists of 48 items, each measuring different stressors on a 5-point Likert scale ranging from 1 (not at all stressful) to 5 (very stressful). The questionnaire includes eight subscales: stress of home, stress of school performance, stress of school attendance, stress of peer pressure, stress of teacher interaction, stress about future uncertainty, stress of school or leisure conflict, and stress of financial pressure. We calculated a composite score by summing the responses, with higher scores indicating greater stress levels (theoretical range 48-240).
Family Cohesionbaseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)We assessed family cohesion using seven items (theoretical range: 7-35, Cronbach alpha = 0.84) adapted from both the Family Environment Scale (Moos, 1994) and the Family Assessment Measure (Skinner et al., 1983). The items measured the degree of commitment, help and support family members provide for one another. Participants were asked to rate how often each item occurred in their family using a 5-point scale (with 1 = 'never' and 5 = 'always'). Items included '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?' Summary scores were created, with higher scores indicating higher levels of family cohesion.
Child-caregiver Relationshipbaseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)The perceived child-caregiver relationship scale was adapted from the Family Assessment measure and assessed 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 were asked to rate the adults they live with, on each of the 16 items (range: 16-80), 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?" Summary mean scores were created, with higher scores indicating a more positive child-caregiver relationship.
Social Supportbaseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)Change in social support was measured by 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.
Perceived Social Supportbaseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)Change in perceived social support was 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. Responses were coded and added up. The theoretical range was 12-60, with higher scores indicating greater social support.
Gender Attitudesbaseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)We assessed gender norms among caregivers using a 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 featured binary responses (Agree = 1 and Disagree = 0). To create a summation score, items in the reverse direction were appropriately reverse-coded (theoretical range 0-10). Higher scores denote more egalitarian gender norms and beliefs.
Savingspost-test (9 months)the average bank savings as measured by Bank statements
Future Orientationbaseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)Change in future orientation was measured by two items evaluating adolescents' expectations and optimism regarding their educational goals. The first item asked 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 asked, 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). For both items, higher scores indicated greater perceived likelihood of achieving educational goals and stronger optimism about the future. A composite future orientation score was created by summing the two items, with higher scores reflecting greater optimism and confidence in achieving educational aspirations. Only participants with non-missing values for both items were included in the composite measure.
Self-Esteembaseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)Self-esteem was measured using the Rosenberg Self-Esteem Scale (RSES) (Rosenberg, 1965). The scale is a common measure of self-esteem (Sinclair et al., 2010) and has been used across different cultural contexts with high internal consistency, including in Ghana (α = 0.83-0.85) (Ahulu et al., 2020; Glozah, 2014). 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 were scored on a theoretical range of 10-40 and summed, with higher scores representing higher self-esteem.
Emotional Self-efficacybaseline, post-test (9 months), 6-month follow-up (15 months)Emotional self-efficacy was assessed using the Emotional self-efficacy scale (ESE; Valois \& Zulig, 2013), an 8-item scale to measure an individual's perceived ability to manage emotions effectively. This scale has been widely used to evaluate emotional self-regulation across different contexts. Participants responded to each item on a 5-point Likert scale ranging from 1 (not at all well) to 5 (very well) (theoretical range 8-40). Sample items included, "How well do you succeed in cheering yourself up when an unpleasant event has happened?" and "How well do you succeed in becoming calm again when you are very scared?" Scores were summed, with higher scores reflecting greater emotional self-efficacy
Social Self-efficacybaseline, post-test (9 months), 6-month follow-up (15 months)Social self-efficacy was measured using the Social self-efficacy scale (Zullig, Teoli, Valois, 2011), a 8-item scale to evaluate an individual's confidence in handling social situations and interactions. Participants rated their responses on a 5-point Likert scale, ranging from 1 (not at all well) to 5 (very well). Sample items included "How well can you express your opinions when other classmates disagree with you?" and "How well can you become friends with other children?" The items were summed, with higher scores indicating greater social self-efficacy (theoretical range 8-40).

Countries

Ghana

Participant flow

Participants by arm

ArmCount
Control: 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 notebooks and lunch in the control arm (bolstered care will also be provided to treatment arm). Primary school education is universal and free in Ghana. Yet notebooks and lunch are costly expenses for families that create a barrier to school attendance. Hence, these will be provided to participants in all study schools.
100
Anzansi Family Program
In addition to bolstered care, participants in this arm will receive the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Anzansi Family Program: the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component: MFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being.
94
Total194

Baseline characteristics

CharacteristicControl: Bolstered CareAnzansi Family ProgramTotal
Age, Categorical
adolescents
<=18 years
50 Participants47 Participants97 Participants
Age, Categorical
adolescents
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
adolescents
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Categorical
caregivers
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
caregivers
>=65 years
2 Participants1 Participants3 Participants
Age, Categorical
caregivers
Between 18 and 65 years
48 Participants46 Participants94 Participants
Race and Ethnicity Not Collected0 Participants
Sex: Female, Male
adolescents
Female
50 Participants47 Participants97 Participants
Sex: Female, Male
adolescents
Male
0 Participants0 Participants0 Participants
Sex: Female, Male
caregivers
Female
27 Participants30 Participants57 Participants
Sex: Female, Male
caregivers
Male
23 Participants17 Participants40 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1000 / 94
other
Total, other adverse events
0 / 1000 / 94
serious
Total, serious adverse events
0 / 1000 / 94

Outcome results

Primary

Intention to Migrate

Change in intention to migrate will be measured by one question: 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: post-test (9 months)

ArmMeasureValue (MEAN)Dispersion
Control: Bolstered CareIntention to Migrate1.42 Score on a scaleStandard Deviation 0.84
Anzansi Family ProgramIntention to Migrate1.28 Score on a scaleStandard Deviation 0.72
p-value: 0.05Linear Mixed-effects regression
Secondary

Attitudes Towards 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.

Time frame: baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)

Secondary

Attitude Towards Work

Attitudes towards work will be measured by Attitudes towards youth employment scale

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Family Functioning

Change in family functioning will be measured by Family Assessment Measure

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Family Relationships

Change in family relations will be measured by Family Environment Scale

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Future Orientation

Change in future orientation will be measured by Thinking about the future measure

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Gender Attitudes

Gender attitudes will be measured by attitudes towards women and gender norm attitudes scales

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Life Satisfaction

change in life satisfaction will be measured by Multidimensional Student Life Satisfaction Scale

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Perceived Social Support

Change in perceived social support will be measured by Multidimensional Scale of Perceived Social Support

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Savings

Change in savings will be measured by Bank statements

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

School Attendance

Change in school attendance will be measured by school attendance reports. Number of missed days will be collected

Time frame: baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)

Population: This outcome only applies to adolescent girls.

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
Control: Bolstered CareSchool Attendancepost-testEqual to or more than 10%26 Participants
Control: Bolstered CareSchool AttendanceBaseline BaselineEqual to or more than 10%27 Participants
Control: Bolstered CareSchool Attendance6-month follow-upLess than 10%27 Participants
Control: Bolstered CareSchool Attendance6-month follow-upEqual to or more than 10%23 Participants
Control: Bolstered CareSchool Attendancepost-testLess than 10%24 Participants
Control: Bolstered CareSchool AttendanceBaseline BaselineLess than 10%23 Participants
Anzansi Family ProgramSchool Attendancepost-testLess than 10%27 Participants
Anzansi Family ProgramSchool AttendanceBaseline BaselineLess than 10%20 Participants
Anzansi Family ProgramSchool Attendance6-month follow-upEqual to or more than 10%15 Participants
Anzansi Family ProgramSchool Attendancepost-testEqual to or more than 10%20 Participants
Anzansi Family ProgramSchool AttendanceBaseline BaselineEqual to or more than 10%27 Participants
Anzansi Family ProgramSchool Attendance6-month follow-upLess than 10%32 Participants
Secondary

Self-concept

Change in self-concept will be measured by Tennessee Self-Concept Scale Short Form

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Self-esteem

Change in self-concept will be measured by Rosenberg self-esteem measure

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Social Support

Change in social support will be measured by Social Support Behavior Scale

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Secondary

Stress

Change in stress levels will be measured by Adolescent Stress Questionnaire

Time frame: baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026