- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02709967
Research Initiative to Support the Empowerment of Girls (RISE)
Cluster Randomized Trial on the Effectiveness of a Girls' Empowerment Programme on Early Childbearing, Marriage and School Dropout Among Adolescent Girls in Rural Zambia
Background Adolescent pregnancies carry risks to the young mothers and the babies. Keeping girls in school can potentially protect girls from getting pregnant. In Zambia, 35% of young rural girls have given birth by the age of 18 years, and the pregnancy rates are particularly high among girls who are out-of-school. Approximately 50% of girls never enroll in secondary school. Widespread myths and negative social norms are barriers to adolescent girls using modern contraceptives, thus contributing to high rates of early pregnancy. However, there is little robust research from Africa on how sexual and reproductive health programmes can be delivered in a way that actually affects early marriage and pregnancy rates.
Purpose To measure the effect on early childbearing rates and basic school completion in a rural Zambian context of (1) economic support to girls and their families, and (2) combining economic support with a community intervention to enhance knowledge about sexual and reproductive health and supportive community norms
Design Cluster randomized controlled trial with three arms with clusters being rural basic schools (With grades 1-9) with surrounding communities.
Study population The participant population were girls enrolled in grade 7 in January in 2016 in rural schools in twelve study districts: Kalomo, Choma, Pemba, Monze, Mazabuka, Chikankata, Kapiri Mposhi, Kabwe, Chisamba, Chibombo, Mkushi, and Luano.
Study size A total of 4922 girls and 157 clusters were recruited, that is 999 girls and 31 clusters in the control arm and 2004 and 63 clusters in the economic support arm and 1919 girls and 63 schools in the combined intervention arms. The rationale for having different numbers of clusters was that we expected larger differences between each of the intervention arms and the control arm than between the two intervention arms themselves.
Intervention One intervention arm was offered economic support in the form of monthly cash transfers to the participating girl and her parents and payment of junior secondary school fees in 2017 and 2018. The second intervention arm was offered the same economic support combined with a community component comprising community meetings about the value of education for adolescent girls and the risks related to early childbearing, and a youth club covering comprehensive sexuality education for girls and boys (both in- and out-of-school).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background Adolescent pregnancies carry risks to the young mothers and their babies. Keeping girls in school can potentially protect girls from getting pregnant. In Zambia, 35% of young rural girls have given birth by the age of 18 years, and the pregnancy rates are particularly high among girls who are out-of-school. Approximately 50% of girls never enroll in secondary school. A number of studies have found that economic support to girls and/or their families can increase school enrolment and attendance, and three trials have found effects on postponement of childbearing and marriage. Other studies indicate that widespread myths and negative social norms are barriers to adolescent girls using modern contraceptives, thus contributing to high rates of early pregnancy. However, there is little robust research from Africa on how sexual and reproductive health programmes can be delivered in a way that actually affects early marriage and pregnancy rates.
Purpose To measure the effect on early childbearing rates and basic school completion in a rural Zambian context of (1) providing economic support to girls and their families, and (2) combining economic support with a community intervention to enhance knowledge about sexual and reproductive health and supportive community norms.
Design Cluster randomized controlled trial with three arms with clusters being rural basic schools (With grades 1-9) with surrounding communities.
Study population The participant population will be girls enrolled in grade 7 in January in 2016 in rural schools in twelve study districts: Kalomo, Choma, Pemba, Monze, Mazabuka, Chikankata, Kapiri Mposhi, Kabwe, Chisamba, Chibombo, Mkushi, and Luano.
Study size A total of 4922 girls and 157 clusters were recruited, that is 999 girls and 31 clusters in the control arm and 2004 and 63 clusters in the economic support arm and 1919 girls and 63 schools in the combined intervention arms. The rationale for having different numbers of clusters was that we expected larger differences between each of the intervention arms and the control arm than between the two intervention arms themselves.
Intervention The control group (31 schools) received writing materials. One intervention group (63 schools) was offered writing materials and economic support in the form of monthly cash transfers to the participating girl and her parents and payment of junior secondary school fees in 2017 and 2018. The second intervention group (63 schools) was offered writing materials, economic support, and a community component. The community component comprised of community meetings about the value of education for adolescent girls and the risks related to early childbearing, and a youth club covering comprehensive sexuality education for girls and boys (both in- and out-of-school).
Duration and Follow-up The duration of the trial, from recruitment to the last follow-up survey was 4.5 years. A baseline survey was conducted just after recruitment, and a final survey was conducted after approximately 4.5 years. In between there were short follow-up contacts with all the participants every six months.
Primary objectives
- To measure the effectiveness of a combined economic and community intervention on childbearing within 8 months of the end of the intervention period
- To measure the effectiveness of economic support alone and of a combined economic and community intervention on childbearing before the 18th birthday among girls.
- To measure the effectiveness of economic support alone and of a combined economic and community intervention on the proportion of girls who sit for the grade 9 exam.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Lusaka, Zambia
- University of Zambia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Female
- Enrolled in grade 7
Exclusion Criteria:
- Moved permanently away from catchment area of school
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 |
---|---|
Active Comparator: Material support
Writing materials
|
Writing materials
|
Experimental: Economic support
Writing materials and economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9).
|
Writing materials
Economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9)
|
Experimental: Combined intervention
Writing materials, economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9) and community dialogue (youth club meetings, community and parent meetings)
|
Writing materials
Economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9)
Community dialogue (youth club meetings, community and parent meetings)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of births within 8 months of the end of the intervention
Time Frame: 44 months after recruitment
|
Will be measured using follow up questionnaire, validated against measurement with final survey questionnaire
|
44 months after recruitment
|
Incidence of births before girls' 18th birthday
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire
|
56 months after recruitment
|
Proportion of girls who sit for grade 9 exam
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire, validated against exam register
|
56 months after recruitment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of marriage/ cohabitation before girls' 16th birthday
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire
|
56 months after recruitment
|
Incidence of marriage/ cohabitation before girls' 18th birthday
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire
|
56 months after recruitment
|
Socioeconomic inequality in incidence of marriage/ cohabitation before girls' 18th birthday
Time Frame: 56 months after recruitment
|
Marriage/cohabitation will be measured using final survey questionnaire.
We will use two measures of socioeconomic status: (i) guardian's highest level of education and (ii) household per capita consumption.
Both socioeconomic measures will be categorized into tertiles of similar size.
|
56 months after recruitment
|
Incidence of pregnancies among girls within 2 years of the end of the interventions
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire
|
56 months after recruitment
|
Incidence of births among girls within 2 years of the end of the interventions
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire
|
56 months after recruitment
|
Incidence of pregnancies before girls' 16th birthday
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire, validated against measurement with follow-up questionnaire at 24-48 months post-recruitment
|
56 months after recruitment
|
Incidence of births before girls' 16th birthday
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire, validated against measurement with follow-up questionnaire at 24-48 months post-recruitment
|
56 months after recruitment
|
Incidence of pregnancies before girls' 18th birthday
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire
|
56 months after recruitment
|
Socioeconomic inequality in incidence of births before girls' 18th birthday
Time Frame: 56 months after recruitment
|
Births will be measured using final survey questionnaire.
We will use two measures of socioeconomic status: (i) guardian's highest level of education and (ii) household per capita consumption.
Both socioeconomic measures will be categorized into tertiles of similar size.
|
56 months after recruitment
|
Proportion of girls enrolled in grade 8
Time Frame: 12 months after recruitment
|
will be measured using follow-up questionnaire, validated against school registers
|
12 months after recruitment
|
Average examination scores of girls from grade 9 in English, mathematics and science
Time Frame: 34 months after recruitment
|
will be measured using grade 9 exam results obtained from District educational boards
|
34 months after recruitment
|
Proportion of girls who enrol in grade 10
Time Frame: 38 months after recruitment
|
will be measured using follow-up questionnaire, validated against school registers and final survey questionnaire at 56 months post-recruitment
|
38 months after recruitment
|
Socioeconomic inequality in participation in grade 9 exam among girls
Time Frame: 56 months after recruitment
|
Participation in grade 9 will be measured using final questionnaire, validated against exam register.
We will use two measures of socioeconomic status: (i) guardian's highest level of education and (ii) household per capita consumption.
Both socioeconomic measures will be categorized into tertiles of similar size.
|
56 months after recruitment
|
Proportion currently using modern contraceptives
Time Frame: 32 months after recruitment
|
Will be measured using final survey questionnaire
|
32 months after recruitment
|
Knowledge of modern contraceptives among adolescent girls
Time Frame: 32 months after recruitment
|
Will be measured using final survey questionnaire
|
32 months after recruitment
|
Perceived community norms regarding modern contraceptive use among unmarried adolescent girls
Time Frame: 32 months after recruitment
|
Will be measured using final survey questionnaire
|
32 months after recruitment
|
Perceived community norms regarding early marriage
Time Frame: 32 months after recruitment
|
Will be measured using final survey questionnaire
|
32 months after recruitment
|
Perceived community norms regarding adolescent pregnancy
Time Frame: 32 months after recruitment
|
Will be measured using final survey questionnaire
|
32 months after recruitment
|
Perceived community norms regarding education among girls
Time Frame: 32 months after recruitment
|
Will be measured using final survey questionnaire
|
32 months after recruitment
|
Proportion of adolescent girls who have been sexually active in last 4 weeks
Time Frame: 32 months after recruitment
|
Will be measured using final survey questionnaire
|
32 months after recruitment
|
Proportion of girls currently employed or self-employed
Time Frame: 56 months after recruitment
|
Will be measured using final survey questionnaire
|
56 months after recruitment
|
School attendance of girls in grade 8
Time Frame: 12 and 18 months after recruitment
|
will be measured using follow-up questionnaire, validated against school registers.
Attending 4 or more days per week on average will be categorized as high attendance, and less than 4 days on average will be categorized as low attendance.
|
12 and 18 months after recruitment
|
School attendance of girls in grade 9
Time Frame: 24 and 30 months after recruitment
|
will be measured using follow-up questionnaire, validated against school registers.
Attending 4 or more days per week on average will be categorized as high attendance, and less than 4 days on average will be categorized as low attendance.
|
24 and 30 months after recruitment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ingvild F Sandøy, PhD, University of Bergen
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 (Estimate)
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
- 2015/895
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Pregnancy in Adolescence
-
The Policy & Research GroupMathematica Policy Research, Inc.; The Office of Adolescent Health, HHSCompleted
-
California State University, San BernardinoDepartment of Health and Human ServicesCompleted
-
Public Health Management CorporationDepartment of Health and Human ServicesCompletedPregnancy in AdolescenceUnited States
-
Portland State UniversityCompletedPregnancy in Adolescence
-
London School of Hygiene and Tropical MedicineCompleted
-
New Jersey Physicians Advisory GroupAMTC & AssociatesRecruitingAdolescent Health | Pregnancy in AdolescenceUnited States
-
University of MichiganSociety of Family PlanningCompletedPregnancy in Adolescence | Teenage Pregnancy and Teen Parenting
-
Children's Mercy Hospital Kansas CityRecruitingPregnancy in Adolescence | Rural Health | Hispanic or LatinoUnited States
-
University of California, BerkeleyYouth Development Labs, Inc dba YLabs; Society for Family Health, RwandaCompletedAdolescent Health | Pregnancy in Adolescence | Health Services AccessibilityRwanda
-
RANDUnknownHIV | Pregnancy in AdolescenceUnited States
Clinical Trials on Material support
-
Medicos e Investigadores en la Lucha contra el...Roche Pharma AGCompletedBreast Cancer | Patient Satisfaction | Knowledge, Attitudes, Practice | Patient EmpowermentMexico
-
NMP Medical Research InstituteMacmillan Research Group UKCompleted
-
University of PittsburghNational Institute of Nursing Research (NINR)CompletedIdiopathic Pulmonary FibrosisUnited States
-
Cereb ABKarolinska InstitutetUnknownAttention Deficit Disorder With HyperactivitySweden
-
University of LuebeckMartin-Luther-Universität Halle-WittenbergCompleted
-
University of British ColumbiaChild and Family Research InstituteCompletedWounds and InjuriesCanada
-
Columbia UniversityPatient-Centered Outcomes Research Institute; NYU Langone Health; Alzheimer's... and other collaboratorsCompletedDepressive Symptoms | BurdenUnited States
-
Coloplast A/SRecruiting
-
University Hospital, GenevaCompleted
-
Acibadem UniversityCompletedPatient Satisfaction | Patient Relations, NurseTurkey