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NCT04231669

Intervention to Improve Developmental and Health Outcomes for Female Adolescents

Completed NA Results posted Last updated 13 February 2026
What this trial tests

NA trial testing Anzansi Family Program in Independent Child Migration in 200 participants. Completed in 30 June 2022.

Timeline
20 July 2020
Primary endpoint
30 June 2022
30 June 2022

Quick facts

Lead sponsorWashington University School of Medicine
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment200
Start date20 July 2020
Primary completion30 June 2022
Estimated completion30 June 2022
Sites1 location across Ghana

Drugs / interventions tested

Conditions studied

Sponsor

Washington University School of Medicine

Who can join

11 and older, any sex, with Independent Child Migration. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intention to Migrate Primary · Baseline, post-test (9 months), 6-months follow-up

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).

6-months follow-up
GroupValue95% CI
Control: Bolstered Care1.72± 1.21
Anzansi Family Program1.15± 0.751
post-test (9 months)
GroupValue95% CI
Control: Bolstered Care1.42± 0.84
Anzansi Family Program1.28± 0.72
Baseline
GroupValue95% CI
Control: Bolstered Care1.6± 1.05
Anzansi Family Program1.64± 1.21
Attitudes Towards School Secondary · baseline, 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).

6 month follow-up
GroupValue95% CI
Treatment Arm90.23± 6.83
Control Arm85.12± 9.64
post-test (9 month
GroupValue95% CI
Treatment Arm80.28± 10.46
Control Arm75.9± 10.85
Baseline
GroupValue95% CI
Treatment Arm87.47± 10.61
Control Arm84.76± 9.46
School Attendance Secondary · baseline, 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

Baseline Baseline
GroupValue95% CI
Control: Bolstered Care23
Anzansi Family Program20
Control: Bolstered Care27
Anzansi Family Program27
post-test
GroupValue95% CI
Control: Bolstered Care24
Anzansi Family Program27
Control: Bolstered Care26
Anzansi Family Program20
6-month follow-up
GroupValue95% CI
Control: Bolstered Care27
Anzansi Family Program32
Control: Bolstered Care23
Anzansi Family Program15
Self-concept Secondary · baseline, 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.

6-months follow-up
GroupValue95% CI
Treatment Arm73.09± 9.17
Control Arm72.74± 9.78
post-test (9 months)
GroupValue95% CI
Treatment Arm76.5± 10.92
Control Arm74.94± 12.58
Baseline
GroupValue95% CI
Treatment Arm80.36± 9.94
Control Arm81.02± 7.83
Multidimensional Student Life Satisfaction Secondary · baseline, 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

6 month follow-up
GroupValue95% CI
Treatment Arm189.83± 19.48
Control Arm183.24± 21.15
post-test (9 months)
GroupValue95% CI
Treatment Arm191.74± 23.42
Control Arm182.92± 23.82
Baseline
GroupValue95% CI
Treatment Arm189.49± 15.20
Control Arm186.98± 15.75
The Adolescent Stress Questionnaire (ASQ) Secondary · 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 h

6 month follow-up
GroupValue95% CI
Treatment Arm174.34± 38.37
Control Arm163.84± 42.70
post-test (9 months)
GroupValue95% CI
Treatment Arm148.52± 49.30
Control Arm164.48± 37.56
Baseline
GroupValue95% CI
Treatment Arm113.40± 46.97
Control Arm117.38± 56.15
Family Cohesion Secondary · baseline, 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 me

Baseline
GroupValue95% CI
Treatment Arm26.55± 6.74
Control Arm28.34± 6.40
post-test (9 months)
GroupValue95% CI
Treatment Arm30.98± 5.52
Control Arm27.5± 6.36
6 month follow-up
GroupValue95% CI
Treatment Arm29.57± 7.12
Control Arm29.04± 6.04
Child-caregiver Relationship Secondary · baseline, 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 includ

Baseline data
GroupValue95% CI
Control: Bolstered Care61.92± 8.82
Anzansi Family Program61.40± 10.01
post-test (9 months)
GroupValue95% CI
Control: Bolstered Care60.44± 6.14
Anzansi Family Program62.98± 6.74
6 month follow-up (6-month post intervention completion)
GroupValue95% CI
Control: Bolstered Care60.56± 6.38
Anzansi Family Program61.45± 4.27
Social Support Secondary · baseline, 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.

Baseline
GroupValue95% CI
Control: Bolstered Care163.26± 26.53
Anzansi Family Program149.83± 30.0
post-test (9 months)
GroupValue95% CI
Control: Bolstered Care171.43± 21.99
Anzansi Family Program183.5± 17.74
6 month follow-up (6-month post intervention completion)
GroupValue95% CI
Control: Bolstered Care164.44± 23.30
Anzansi Family Program183.28± 22.95
Perceived Social Support Secondary · baseline, 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.

6 month follow-up
GroupValue95% CI
Treatment Arm36.62± 3.75
Control Arm34.32± 5.68
post-test (9 months),
GroupValue95% CI
Treatment Arm35.54± 4.11
Control Arm30.18± 6.38
Baseline
GroupValue95% CI
Treatment Arm32.51± 4.86
Control Arm32.32± 4.44
Gender Attitudes Secondary · baseline, 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 direct

6 month follow-up
GroupValue95% CI
Control: Bolstered Care2.7± 2.18
Anzansi Family Program3.04± 1.77
post-test (9 months)
GroupValue95% CI
Control: Bolstered Care2.84± 2.72
Anzansi Family Program3.39± 2.91
Baseline
GroupValue95% CI
Control: Bolstered Care2.06± 2.19
Anzansi Family Program2.44± 2.17
Savings Secondary · post-test (9 months)

the average bank savings as measured by Bank statements

GroupValue95% CI
Anzansi Family Program401± 175

Sponsor's own 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 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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Anzansi family program: a study protocol for a combination intervention addressing developmental and health outcomes for adolescent girls at risk of unaccompanied migration.
    Sensoy Bahar O, Ssewamala FM, Ibrahim A, Boateng A, et al · · 2020 · cited 6× · PMID 33372647 · DOI 10.1186/s40814-020-00737-4
  2. Short-term impact of a combination intervention on family cohesion: Results from a pilot cluster-randomized clinical trial in Northern Ghana.
    Sensoy Bahar O, Byansi W, Ibrahim A, Boateng A, et al · · 2024 · PMID 38825788 · DOI 10.1111/jora.12977

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing