Teen motHers' ReproductIve and behaVioral Health intErvention in Barbados (THRIVE)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Systolic Blood Pressure (mmHg)
研究概览
简要总结
The goal of this clinical trial is to learn if an integrated care program can help improve overall health and prevent repeat pregnancy in teen mothers in Barbados. The study focuses on young women ages 10 to 25 who became pregnant during their teenage years and are experiencing stress or mood-related symptoms. This study is currently pending ethics committee review and has not yet begun enrolling participants.
The main questions it aims to answer are:
- Does the THRIVE program improve participants' mental health and parenting skills?
- Does the program help prevent repeat, unplanned pregnancies?
Researchers will compare participants who receive the THRIVE program to those who receive standard care to see if the program leads to better physical and emotional health.
Participants will:
- Take part in seven biweekly in-person or virtual sessions focused on reproductive and behavioral health;
- Complete health checks and questionnaires about their mood, parenting stress, and support;
- Receive follow-up contact after the sessions are completed.
The THRIVE program includes education on sexual health, mental health, parenting, and life skills. Participants will receive small incentives and support throughout the study. All study activities will begin only after full ethics approval is obtained.
详细描述
Teen pregnancy remains a significant public health concern in many parts of the world, including Latin America and the Caribbean (LAC). Young mothers in these regions often experience high rates of repeat, unplanned pregnancies, mental health challenges, limited educational opportunities, and reduced access to reproductive and behavioral health care. Despite the need, there are few published, evidence-based interventions targeting this population in the Caribbean, and even fewer that take a holistic, integrated approach.
This study introduces THRIVE - Teen motHers' ReproductIve and behaVioral health intErvention - a novel, integrated care program designed to support the overall health and development of young mothers in Barbados who became pregnant during adolescence. The THRIVE program provides education and support in both reproductive and behavioral health, recognizing that these domains are deeply interconnected in the lives of young mothers.
The study is a randomized controlled trial (RCT). It is designed to assess whether the THRIVE intervention improves participants' mental health, parenting confidence, and reproductive health outcomes compared to standard care. It also aims to reduce the risk of repeat adolescent pregnancy and promote engagement in school or professional development.
Background and Rationale Studies in high-income countries have shown that teen pregnancy prevention efforts are most effective when they include empowerment through education and psycho-social support. However, in LAC regions such as Barbados, there is a lack of published evidence on whether similar approaches can be successfully adapted and implemented. Many existing programs narrowly focus on a single health domain (e.g., sexual health education or treatment of depressive symptoms) and often overlook the broader context of a teen mother's life, including parenting stress, family support, and barriers to education or employment.
THRIVE was developed in response to this gap. It is a culturally appropriate, multidimensional intervention that integrates reproductive and behavioral health education tailored specifically for young mothers in Barbados. This study seeks to generate scientific evidence on the feasibility, acceptability, and preliminary effectiveness of THRIVE, laying the foundation for future longitudinal studies in the region.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Participants, care providers, and outcomes assessors will not be informed of group assignments. Randomization and assignment will be handled by third-party study personnel.
入排标准
- 年龄范围
- 10 Years 至 25 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Young mothers aged 10 to 25 years residing in Barbados
- •Experienced adolescent pregnancy between ages 10 and 19 years
- •Living in low-income households with annual income BDS $20,000 (~USD 10,000) or below
- •Screen positive for depressed mood symptoms using the Patient Health Questionnaire-2 (PHQ-2), indicating feeling "little interest or pleasure in doing things" and/or feeling "down, depressed, or hopeless" over the past 2 weeks
- •Able to provide informed consent or assent (with parental consent if under legal age)
- •Willing to complete study questionnaires and attend scheduled visits
排除标准
- •History of heart disease, head trauma, hypertension, diabetes, psychiatric, or neurological conditions
- •Severe cognitive or medical conditions preventing participation
- •Enrollment in conflicting interventional studies
- •Insufficient proficiency in study languages without access to interpretation (if applicable)
结局指标
主要结局
Systolic Blood Pressure (mmHg)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Systolic blood pressure will be measured using a calibrated sphygmomanometer or automated device after participants have been seated and rested for 5 minutes.
Diastolic Blood Pressure (mmHg)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Diastolic blood pressure will be measured using the same method and protocol as systolic pressure. Unit of Measure: mmHg
Heart Rate (bpm)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Heart rate will be measured in beats per minute using standard clinical methods. Units: Beats per minute (bpm)
Respiration Rate (breaths per minute)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Respiration rate will be measured as the number of breaths per minute.
Glucose Level (mg/dL)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Blood glucose level will be measured via fingerstick or venous blood sample. Units: Milligrams per deciliter (mg/dL).
Body Temperature (°C)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Body temperature will be measured using a clinical thermometer (oral or tympanic) in degrees Celsius. Units: Degrees Celsius (°C)
Overall Health related to Mood-related symptoms Assessed by Patient Health Questionnaire-9 (PHQ-9) [Score Range: 0-27, Higher Scores Indicate Worse Outcome]
时间窗: At baseline, each site visit (e.g., bi-monthly for 6 months), and 6 months post-intervention
Overall health related to mood-related symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale assessing frequency of depressive-like symptoms over the past two weeks. Each item is scored from 0 (Not at all) to 3 (Nearly every day), producing a total score range of 0 to 27. Higher scores indicate more severe depression. Unit of Measure: PHQ-9 total score (0-27)
State Anxiety - State-Trait Anxiety Inventory (STAI or STAI-CH)
时间窗: At baseline, week 24, and 6 months post-intervention
STAI (or STAI-CH for adolescents) is a 20-item scale assessing anxiety symptoms. Min Score: 20. Max Score: 80. Higher scores indicate greater anxiety.
Depressive Symptoms in Adolescents - Center for Epidemiologic Studies Depression Scale (CES-D)
时间窗: At baseline, week 24, and 6 months post-intervention
A 20-item validated scale used widely in adolescent and pregnant populations.Min Score: 0. Max Score: 60. Higher scores indicate more depressive symptoms.
Parenting Stress - Parenting Stress Index (PSI) Short Form
时间窗: At baseline, week 24, and 6 months post-intervention
Measures perceived stress related to parenting using the PSI-SF, a 36-item validated tool. Min Score: 36. Max Score: 180. Higher scores indicate higher levels of stress.
Parenting Attitudes and Beliefs - Adult-Adolescent Parenting Inventory (AAPI-2)
时间窗: Baseline and through study completion, an average of 1 year
he AAPI-2 measures parenting beliefs and risk of abusive or harmful parenting practices. Min Score: 40. Max Score: 200. Higher scores indicate more appropriate/positive parenting attitudes.
Postpartum Social Support - Custom Self-Report Composite
时间窗: Baseline, Week 12, and Week 24
A composite measure including self-report variables on school status, repeat pregnancy, abuse history, substance use, and access to care. Unit of Measure: Categorical and descriptive data (each item analyzed separately)
Height (cm)
时间窗: Baseline, Week 24
Height will be measured using a stadiometer. Units: centimeters (cm)
Weight (lbs)
时间窗: At baseline and each site visit (e.g., bimonthly for 6 months)
Weight will be measured using a calibrated scale. Units: pounds (lbs)
Systolic Blood Pressure (mmHg)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Systolic blood pressure will be measured using a calibrated sphygmomanometer or automated device after participants have been seated and rested for 5 minutes.
Diastolic Blood Pressure (mmHg)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Diastolic blood pressure will be measured using the same method and protocol as systolic pressure. Unit of Measure: mmHg
Heart Rate (bpm)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Heart rate will be measured in beats per minute using standard clinical methods. Units: Beats per minute (bpm)
Glucose Level (mg/dL)
时间窗: At baseline and each site visit (e.g., bi-monthly for 6 months)
Blood glucose level will be measured via fingerstick or venous blood sample. Units: Milligrams per deciliter (mg/dL).
Overall Health related to Mood-related symptoms Assessed by Patient Health Questionnaire-9 (PHQ-9) [Score Range: 0-27, Higher Scores Indicate Worse Outcome]
时间窗: At baseline, each site visit (e.g., bi-monthly for 6 months), and 6 months post-intervention
Overall health related to mood-related symptoms will be assessed using the Patient Health Questionnaire-9 (PHQ-9), a 9-item self-report scale assessing frequency of depressive-like symptoms over the past two weeks. Each item is scored from 0 (Not at all) to 3 (Nearly every day), producing a total score range of 0 to 27. Higher scores indicate more severe depression. Unit of Measure: PHQ-9 total score (0-27)
State Anxiety - State-Trait Anxiety Inventory (STAI or STAI-CH)
时间窗: At baseline, week 24, and 6 months post-intervention
STAI (or STAI-CH for adolescents) is a 20-item scale assessing anxiety symptoms. Min Score: 20. Max Score: 80. Higher scores indicate greater anxiety.
Parenting Stress - Parenting Stress Index (PSI) Short Form
时间窗: At baseline, week 24, and 6 months post-intervention
Measures perceived stress related to parenting using the PSI-SF, a 36-item validated tool. Min Score: 36. Max Score: 180. Higher scores indicate higher levels of stress.
Parenting Attitudes and Beliefs - Adult-Adolescent Parenting Inventory (AAPI-2)
时间窗: Baseline and through study completion, an average of 1 year
he AAPI-2 measures parenting beliefs and risk of abusive or harmful parenting practices. Min Score: 40. Max Score: 200. Higher scores indicate more appropriate/positive parenting attitudes.
Postpartum Social Support - Custom Self-Report Composite
时间窗: Baseline, Week 12, and Week 24
A composite measure including self-report variables on school status, repeat pregnancy, abuse history, substance use, and access to care. Unit of Measure: Categorical and descriptive data (each item analyzed separately)
Height (cm)
时间窗: Baseline, Week 24
Height will be measured using a stadiometer. Units: centimeters (cm)
Weight (lbs)
时间窗: At baseline and each site visit (e.g., bimonthly for 6 months)
Weight will be measured using a calibrated scale. Units: pounds (lbs)
次要结局
- Satisfaction with Responsiveness to needs in Integrated Care Model(Week 24)
- Overall Satisfaction with Integrated Care Model(Week 24)
- Changes in healthcare utilization(Through study completion, an average of 12 months)
- Child Developmental Outcomes - Ages and Stages Questionnaire (ASQ)(At 6 months and 12 months postpartum)
- Child Growth - Weight (kg)(At 6 months and 12 months postpartum)
- Child Growth - Height (cm)(At 6 months and 12 months postpartum)
- Incidence of repeat pregnancy within study period(Up to 12 months postpartum)
- Mental health service utilization(through study completion, an average of 1 year)
- Changes in Knowledge and Attitudes Toward Contraception and Sexual Health - THRIVE KASH-Q(through study completion, an average of 1 year)
- Satisfaction with Communication with healthcare providers in Integrated Care Model(Week 24)
- Satisfaction with Access to Care in Integrated Care Model(Week 24)
- Satisfaction with Care Coordination in Integrated Care Model(Week 24)
- Satisfaction with Responsiveness to needs in Integrated Care Model(Week 24)
- Overall Satisfaction with Integrated Care Model(Week 24)
- Child Growth - Height (cm)(At 6 months and 12 months postpartum)
- Mental health service utilization(through study completion, an average of 1 year)
- Changes in Knowledge and Attitudes Toward Contraception and Sexual Health - THRIVE KASH-Q(through study completion, an average of 1 year)
- Changes in healthcare utilization(Through study completion, an average of 12 months)
- Child Developmental Outcomes - Ages and Stages Questionnaire (ASQ)(At 6 months and 12 months postpartum)
- Child Growth - Weight (kg)(At 6 months and 12 months postpartum)
- Incidence of repeat pregnancy within study period(Up to 12 months postpartum)
- Satisfaction with Communication with healthcare providers in Integrated Care Model(Week 24)
- Satisfaction with Access to Care in Integrated Care Model(Week 24)
- Satisfaction with Care Coordination in Integrated Care Model(Week 24)
研究者
Hada Fongha Ieong, PhD
Principal Investigator and Sponsor-Investigator
Ross University School of Medicine