Teen motHers' ReproductIve and behaVioral Health intErvention in Barbados

NCT07149948 | Not Yet Recruiting

• 1 other identifier: RUSM20240405-CANREC20250903
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnancy in Adolescence

Keywords

Integrated care; Barbados; Caribbean health; Psychoeducation; Community-based intervention; Global Health; THRIVE; Adolescent Pregnancy; Teenage Mothers; Parenting; Reproductive Health; Mental Health; School Reentry; Family Planning Services; Contraceptive Use; Low-Income Population; Behavioral Health; Anxiety; Depression

Outcome Measures

Primary Outcomes (14)

• 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.

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

• Diastolic Blood Pressure (mmHg)

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

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

• Heart Rate (bpm)

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

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

• Respiration Rate (breaths per minute)

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

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

• Glucose Level (mg/dL)

  Blood glucose level will be measured via fingerstick or venous blood sample. Units: Milligrams per deciliter (mg/dL).

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

• Body Temperature (°C)

  Body temperature will be measured using a clinical thermometer (oral or tympanic) in degrees Celsius. Units: Degrees Celsius (°C)

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

• Overall Health related to Mood-related symptoms Assessed by Patient Health Questionnaire-9 (PHQ-9) [Score Range: 0-27, Higher Scores Indicate Worse Outcome]

  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)

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

• State Anxiety - State-Trait Anxiety Inventory (STAI or STAI-CH)

  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.

  At baseline, week 24, and 6 months post-intervention

• Depressive Symptoms in Adolescents - Center for Epidemiologic Studies Depression Scale (CES-D)

  A 20-item validated scale used widely in adolescent and pregnant populations.Min Score: 0. Max Score: 60. Higher scores indicate more depressive symptoms.

  At baseline, week 24, and 6 months post-intervention

• Parenting Stress - Parenting Stress Index (PSI) Short Form

  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.

  At baseline, week 24, and 6 months post-intervention

• Parenting Attitudes and Beliefs - Adult-Adolescent Parenting Inventory (AAPI-2)

  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.

  Baseline and through study completion, an average of 1 year

• Postpartum Social Support - Custom Self-Report Composite

  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)

  Baseline, Week 12, and Week 24

• Height (cm)

  Height will be measured using a stadiometer. Units: centimeters (cm)

  Baseline, Week 24

• Weight (lbs)

  Weight will be measured using a calibrated scale. Units: pounds (lbs)

  At baseline and each site visit (e.g., bimonthly for 6 months)

Secondary Outcomes (12)

• 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

Study Arms (2)

THRIVE Integrated Care Intervention

EXPERIMENTAL

Participants in this arm will receive the THRIVE integrated reproductive and behavioral health intervention, consisting of seven biweekly psychoeducation modules delivered in-person or via Zoom. The program addresses reproductive health knowledge, parenting skills, mental health, substance use, and life skills to prevent repeat adolescent pregnancy.

Behavioral: THRIVE Integrated Care Program

Standard Care Control

NO INTERVENTION

Participants in this arm will receive standard postnatal and psychosocial care provided by community health centers in Barbados, such as health check-ups and basic social support services. They will not receive the THRIVE modules.

Interventions

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.

Also known as: THRIVE

THRIVE Integrated Care Intervention

Eligibility Criteria

• Age: 10 Years - 25 Years
• Gender Eligibility Details: Eligibility is based on biological sex, not gender identity.
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hada Fongha Ieong, PhD: lead
• Rotary Club of Barbados: collaborator

Study Sites (1)

Rotary Club of Barbados

Bridgetown, BB15156, Barbados

Location

Related Publications (1)

• Ieong HF, Cobbin M, Tlachi P, Chidsey C, Flaks R, Ross A. Barriers to randomized trials of integrated care for adolescent mothers in the Caribbean: lessons from the THRIVE trial and the Project Amai in Barbados. Trials. 2025 Dec 17;27(1):65. doi: 10.1186/s13063-025-09359-8.

  PMID: 41408317 RESULT

Related Links

• Barriers to randomized trials of integrated care for adolescent mothers in the Caribbean: lessons from the THRIVE trial and the Project Amai in Barbados

MeSH Terms

Conditions

Psychological Well-Being; Anxiety Disorders; Depression

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Mental Disorders; Behavioral Symptoms

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Hada Fongha Ieong, PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hada Fongha Ieong, PhD

CONTACT

2039094688; hadafonghaieong@mail.rossmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, and outcomes assessors will not be informed of group assignments. Randomization and assignment will be handled by third-party study personnel.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator and Sponsor-Investigator

Model Details: Participants will be randomly assigned to either the THRIVE integrated care intervention group or the standard care control group, and each group will receive their respective care in parallel throughout the study period.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: September 2, 2025
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)