- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04231669
Intervention to Improve Developmental and Health Outcomes for Female Adolescents
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Accra, Ghana
- University of Ghana
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 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.
|
|
|
Experimental: Anzansi Family Program
In addition to bolstered care, participants(adolescent girls and caregivers) in this arm will receive the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG).
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intention to Migrate
Time Frame: 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).
|
Baseline, post-test (9 months), 6-months follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
School Attendance
Time Frame: 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, post-test (9 month), 6 month follow-up (6-month post intervention completion)
|
|
Attitudes Towards School
Time Frame: 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).
|
baseline, post-test (9 month), 6 month follow-up (6-month post intervention completion)
|
|
Self-concept
Time Frame: 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.
|
baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
Multidimensional Student Life Satisfaction
Time Frame: 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 values representing higher satisfaction in student life.
|
baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
The Adolescent Stress Questionnaire (ASQ)
Time Frame: 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).
|
baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
Family Cohesion
Time Frame: 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 members have to say, even when you disagree?' Summary scores were created, with higher scores indicating higher levels of family cohesion.
|
baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
Child-caregiver Relationship
Time Frame: 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 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.
|
baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
Social Support
Time Frame: 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, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
Perceived Social Support
Time Frame: 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. |
baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
Gender Attitudes
Time Frame: 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 direction were appropriately reverse-coded (theoretical range 0-10).
Higher scores denote more egalitarian gender norms and beliefs.
|
baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
Savings
Time Frame: post-test (9 months)
|
the average bank savings as measured by Bank statements
|
post-test (9 months)
|
|
Future Orientation
Time Frame: baseline, 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.
|
baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
Self-Esteem
Time Frame: baseline, 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.
|
baseline, post-test (9 months), 6 month follow-up (6-month post intervention completion)
|
|
Emotional Self-efficacy
Time Frame: baseline, 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
|
baseline, post-test (9 months), 6-month follow-up (15 months)
|
|
Social Self-efficacy
Time Frame: baseline, 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).
|
baseline, post-test (9 months), 6-month follow-up (15 months)
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- R21HD099508 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Independent Child Migration
-
Cairo UniversityCompletedIntrauterine Device MigrationEgypt
-
New York UniversityWashington University School of Medicine; University of GhanaRecruitingUnaccompanied MigrationGhana
-
Fondation Ophtalmologique Adolphe de RothschildCompletedIntrauterine Device Migration | Menstrual CupFrance
-
Ankara City Hospital BilkentCompleted
-
Assiut UniversityCompletedIntrauterine Device MigrationEgypt
-
Asian Institute of Gastroenterology, IndiaOvesco Endoscopy AGNot yet recruiting
-
Swiss Federal Institute of TechnologyCompletedAged | Independent LivingSwitzerland
-
Kanuni Sultan Suleyman Training and Research HospitalCompletedPain | Intrauterine Device MigrationTurkey (Türkiye)
-
Sparrow PharmaceuticalsCompletedAutonomous Cortisol Secretion (ACS) | ACTH-Independent Cushing Syndrome | ACTH-Independent Adrenal Cushing Syndrome, SomaticUnited States, Romania, United Kingdom
Clinical Trials on Anzansi Family Program
-
New York UniversityWashington University School of Medicine; University of GhanaRecruitingUnaccompanied MigrationGhana
-
Social Insurance Institution, FinlandTurku University Hospital; University of TurkuCompletedADHD | Asperger Syndrome | Child Behavior DisordersFinland
-
Massachusetts General HospitalNot yet recruitingBrain Injury | Coma | Emotional Distress | Resilience | Caregivers | Caregiver DistressUnited States
-
Pontificia Universidad Catolica de ValparaisoAgencia Nacional de Investigación y DesarrolloCompletedPhysical Activity | Sleep | Exercise | Health Promotion | Physical Fitness | Sedentary BehaviorsChile
-
Sorlandet Hospital HFCompleted
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)CompletedAnxiety DisorderCanada
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)CompletedPediatric Disruptive Behaviour DisorderCanada
-
Rutgers, The State University of New JerseyAgency for Healthcare Research and Quality (AHRQ)CompletedParenting | Health Behavior | Language Development | LiteracyUnited States
-
IRCCS Centro San Giovanni di Dio FatebenefratelliAzienda Socio Sanitaria Territoriale del Garda; Department of Clinical Neurosciences... and other collaboratorsCompleted
-
Matthew ModesNational Palliative Care Research CenterRecruitingCritical Illness | Respiratory Failure | Physician-Patient Relations | Family SupportUnited States