Health Trials

Teen motHers' ReproductIve and behaVioral Health intErvention in Barbados

ConditionPregnancy in Adolescence
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age10-25
SponsorHada Fongha Ieong, PhD

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • THRIVE Integrated Care Program

    Behavioral

    The THRIVE Integrated Care Program is a psychoeducational behavioral intervention for adolescent mothers that combines reproductive health education and mental health support. It includes seven biweekly in-person or virtual sessions covering topics such as sexual health, parenting, mental health, substance use prevention, social support, and professional development. The intervention is delivered by trained medical students and staff using interactive learning modules and assessments.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: THRIVE Integrated Care InterventionExperimental treatment 1 intervention
Group B: Standard Care ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Systolic Blood Pressure (mmHg)

Systolic blood pressure will be measured using a calibrated sphygmomanometer or automated device after participants have been seated and rested for 5 minutes.

Time frame
At baseline and each site visit (e.g., bi-monthly for 6 months)
2

Diastolic Blood Pressure (mmHg)

Diastolic blood pressure will be measured using the same method and protocol as systolic pressure. Unit of Measure: mmHg

Time frame
At baseline and each site visit (e.g., bi-monthly for 6 months)
3

Heart Rate (bpm)

Heart rate will be measured in beats per minute using standard clinical methods. Units: Beats per minute (bpm)

Time frame
At baseline and each site visit (e.g., bi-monthly for 6 months)
4

Respiration Rate (breaths per minute)

Respiration rate will be measured as the number of breaths per minute.

Time frame
At baseline and each site visit (e.g., bi-monthly for 6 months)

Secondary outcomes

1

Changes in healthcare utilization

Frequency of clinic visits, emergency room visits, and use of preventive health services over the study period. Unit of Measure: Number of visits per participant.

Time frame
Through study completion, an average of 12 months
2

Child Developmental Outcomes - Ages and Stages Questionnaire (ASQ)

Physical, emotional, and cognitive development milestones assessed via the Ages and Stages Questionnaire. Min Score: 0. Max Score: Varies by domain and age. Higher scores indicate more age-appropriate development.

Time frame
At 6 months and 12 months postpartum
3

Child Growth - Weight (kg)

Weight of the child measured using standard pediatric scales. Unit of Measure: Kilograms

Time frame
At 6 months and 12 months postpartum
4

Child Growth - Height (cm)

Height/length of the child measured using standard equipment. Unit of Measure: Centimeters

Time frame
At 6 months and 12 months postpartum

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hada Fongha Ieong, PhD

Lead sponsor

Ross University School of Medicine

Sponsor institution

Rotary Club of Barbados

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: