Improving educational and health outcomes for adolescent mothers in Kenya: The PROMOTE II randomized controlled trial

Last registered on May 30, 2025

Pre-Trial

Trial Information

General Information

Title
Improving educational and health outcomes for adolescent mothers in Kenya: The PROMOTE II randomized controlled trial
RCT ID
AEARCTR-0016114
Initial registration date
May 30, 2025

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
May 30, 2025, 10:17 AM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
African Population & Health Research Centre, Kenya

Other Primary Investigator(s)

PI Affiliation
African Population and Health Research Center
PI Affiliation
African Population and Health Research Center
PI Affiliation
African Population and Health Research Center
PI Affiliation
African Population and Health Research Center

Additional Trial Information

Status
In development
Start date
2025-06-30
End date
2026-08-31
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Background
Despite the numerous challenges adolescent mothers encounter, such as dropping out of school, experiencing domestic violence, living in poverty, low contraceptive use, and repeat pregnancies, there have been few well-tested interventions aimed at improving their health and socioeconomic wellbeing and that of their children. To enhance the health and social outcomes for adolescent mothers and their children, it is essential to address the gendered social norms and hierarchies that limit their educational opportunities, financial prospects, and economic security. Multi-level interventions that provide financial, childcare and life skill education support could facilitate adolescent mothers return to school, skill acquisition, reduction in domestic violence, and improve their sexual and reproductive health (SRH) and mental health outcomes.
Interventions
We plan to implement three interventions in Korogocho and Viwandani settlements in, Nairobi: cash transfers contingent on re-enrolling in school or vocational training, subsidized childcare, and life skills training offered through adolescent mothers' clubs. The life skills training will include nurturing childcare, SRH, mental health, and financial literacy. Mentors from the communities will facilitate these clubs, and each intervention will run for 12 months.
Methods
We will evaluate the effectiveness of these interventions using a parallel, open-label, equivalence randomized controlled trial (RCT). A total of 585 adolescent mothers will be recruited through two-stage sampling and randomly assigned to either of the three study arms in a 1:1:1 ratio at 195 participants per study arm. Arm one will receive all three interventions, arm two will receive life skills training only, and arm three will serve as the control group. We will measure schooling, vocational training, SRH knowledge, contraceptive use, gender norms, attitudes towards intimate partner violence, experiences of intimate partner violence, sexual behaviors, and symptoms of depression at baseline and at the end of the 12-month period. Data will be analyzed using an intention-to-treat approach, comparing baseline and endline measures while controlling for confounders. Qualitative data collected from intervention monitoring and process evaluation will be analyzed using thematic analysis to identify key lessons and challenges encountered during the implementation of these interventions
Discussion
The study will produce robust evidence on the effectiveness of childcare support, life skills training, and conditional cash transfers in promoting school reentry and vocational skill acquisition, as well as improving SRH knowledge, behaviors, and mental health among adolescent mothers. The findings will be used to engage key stakeholders to ensure evidence uptake in policies and interventions to improve the wellbeing of adolescent mothers.
External Link(s)

Registration Citation

Citation
Ajayi, Anthony et al. 2025. "Improving educational and health outcomes for adolescent mothers in Kenya: The PROMOTE II randomized controlled trial ." AEA RCT Registry. May 30. https://doi.org/10.1257/rct.16114-1.0
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Experimental Details

Interventions

Intervention(s)
Most adolescent mothers face numerous health, education, and livelihood struggles. However, there is little evidence of what programs can help them overcome these challenges. We will test whether providing adolescent mothers with childcare support, life skills training, and conditional cash transfers over 12 months can help them to return to school, engage in vocational training, or improve their sexual and reproductive health, and mental wellbeing. We will divide 585 adolescent mothers selected from Korogocho and Viwandani into three groups at random. Those in group one will serve as a control group, those in group two will receive life skill training only and those in group three will serve receive all interventions. The control group control will get stipends at the end of the study. We will compare adolescent mothers in the three groups to assess whether those who receive the interventions are more likely that those who do not to return to school, engage in vocation training or have better sexual and reproductive health, and mental wellbeing. We will use the evidence we generate to engage key stakeholders and garner additional support for adolescent mothers.
Intervention Start Date
2025-08-01
Intervention End Date
2026-07-31

Primary Outcomes

Primary Outcomes (end points)
The primary outcome of this study is (re)entry or (re)enrolment in school or vocational training.
Primary Outcomes (explanation)
The primary outcome of this study is (re)entry or (re)enrolment in school or vocational training. Participants will be surveyed about their current enrolment status and their plans to return to school or vocational training at baseline. At the endline survey, participants will be asked if they have attended school or vocational training at any time since the initial survey. The main outcome will be a binary variable, with '1' indicating 'yes' and '0' indicating 'no,' reflecting whether participants were enrolled in school or vocational training during the 12-month intervention period.

Secondary Outcomes

Secondary Outcomes (end points)
SRH knowledge and behaviours
Norms change
Mental health
Child developmental outcomes
Secondary Outcomes (explanation)
We will measure SRH knowledge using questions that assess knowledge about HIV and its transmission route, the menstrual cycle, and contraceptive methods. These questions have been previously validated and used in Demographic and Health Surveys.
We will measure contraceptive use by asking participants what methods they use to delay or avoid pregnancy when they do not want to be pregnant. The measure of contraceptives has been previously validated.
We will measure transactional sex using questions on the exchange of sex for money, rent, food, shelter, school fees phone/airtime, clothes/shoes/beauty products, sanitary pads, and protection. These questions have been used in previous studies.
We will measure intimate partner violence using 15 previously validated questions on sexual, physical, and emotional violence used in Demographic and Health Surveys.
We will measure unequal gender norms in relationships using an 8-item scale. This scale will explore various aspects of what a woman should or should not do in a relationship, including refusing sex, choosing a partner, deciding on contraceptive use, support for polygamy, and whether a man should cook or have sex with his wife whenever he wants.
Acceptance of wife-beating will be measured using five questions specifying conditions when it is justifiable to beat a wife and probing if respondents endorse wife-beating under those situations. These questions have been previously validated and used in Demographic and Health Surveys.
Patient Health Questionnaire-9 (PHQ-9) will be used to measure depression symptoms.
We will use the Ages and Stages tool to assess children’s early development [85, 86].

Experimental Design

Experimental Design
We will conduct a parallel, open-label, equivalence randomized controlled trial (RCT) to estimate the combined effect of conditional cash transfers, subsidized childcare, and life skills training on adolescent mothers' re-entry into school or vocational training. Additionally, we aim to examine the interventions' impact on SRH outcomes and mental health as secondary outcomes, as well as determine their cost-effectiveness. Following a household listing, eligible adolescent mothers will be randomly assigned to one of three study arms. Those in arm one will receive life skills training through adolescent mothers' clubs, subsidized childcare, and conditional cash transfers. Those in arm two will receive the life skill curriculum only. Arm three will be the control group. Those in arm three will receive a stipend at the end of the study and are recommended for life skills training. A baseline survey will be conducted before randomization to measure baseline characteristics. At the end of the intervention period (12 months), all participants will complete an endline survey. Figure 2 illustrates the study design.
Experimental Design Details
Not available
Randomization Method
Randomization
After baseline household listing to identify eligible adolescents and baseline data collection, adolescent mothers will be randomly assigned to one of the three arms using computer-generated random numbers.
6.8 Allocation, Concealment, Implementation and Blinding
Participants will be allocated on a one-to-one ratio into the three arms. Allocation will be managed by an external party using Microsoft Excel and will remain concealed until the intervention begins. Two local community-based organizations will enroll participants in the study and will receive the names and contacts of those in the intervention arms at the start of the intervention. The study will employ open-label blinding, as participants in the intervention group will interact with facilitators and the study team. Due to the nature of the interventions in this study, implementing blinding is not feasible. While contamination is unlikely given the nature of the interventions, internal validity could be affected by demoralization among adolescent mothers in the control group who become aware of the interventions leading to selective attrition. We will take steps to explain the study rationale to all participants, ensuring they understand that beneficiaries are selected at random. Those in the control group will receive stipends at the end of the study and will be recommended for similar interventions offered by local CBOs.
Randomization Unit
Individual randomization
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
The total sample size is 585 adolescent mothers (195 per arm)
Sample size: planned number of observations
585 adolescent mothers
Sample size (or number of clusters) by treatment arms
195 for control, 195 for treatment group 1 and 195 for treatment group 2.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
The sample size is calculated to compare two intervention arms with the control arm, focusing on (re)enrolment in school or vocational training as the primary outcome. The sample size estimation is based on the following parameters: In a survey conducted in Kenya, 91% of pregnant or parenting adolescents were out of school [41]. A study by the Population Council found that 10-16% of girls re-entered school following an intervention involving policy dialogue, values clarification, and advocacy [87]. Since our intervention addresses key barriers identified in the Population Council study, we expect a higher re-entry rate. We assume a minimum 20% absolute reduction in the proportion of adolescents not in school due to our intervention. For this study, the minimum total sample size needed to detect significant differences between the intervention and control arms, with a 5% significance level, Bonferroni’s correction for multiplicity, and 80% power, is 234 adolescent mothers for the three arms, assuming equal allocation. Considering a 40% attrition rate and a design effect of 1.5 due to possible stratification by slum area, the required total sample size is 585 adolescent mothers (195 per arm). The attrition rate of 40% was based on the pilot study we conducted in Burkina Faso and Malawi.
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
AMREF ESRC
IRB Approval Date
2025-05-27
IRB Approval Number
ESRC P1879/2025
Analysis Plan

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