Evaluation of the Talking Matters Teen Pregnancy Prevention Program

NCT ID: NCT04970485

Last Updated: 2024-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 321 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-15
• Study Completion Date: 2023-12-31

Brief Summary

A culturally tailored program that creates a safe, open space to increase knowledge, self-efficacy, skills, and comfort related to sexual and reproductive health, including HIV/STI and teen pregnancy prevention, mental health, and substance use risk reduction behavior, and strengthens protective factors, decision-making skills, and connections to trusted adults may help participants chart a path toward optimal health. To address a significant gap in evidence-based, culturally-tailored sexual and reproductive health services for Black and African American adolescents, Public Health Management Corporation (PHMC) is conducting a rigorous evaluation of an innovative group-level, two pronged intervention called Talking Matters using an individual randomized control trial (RCT) design. Due to social distancing guidelines during COVID-19 at the start of the study, all Talking Matters activities, including recruitment, screening, consent, intervention implementation, and data collection, will be conduct virtually and remotely.

Developed and piloted over the past two years through FY2018 Phase I New and Innovative Strategies (Tier 2) to Prevent Teen Pregnancy and Promote Healthy Adolescence funding from the Office of Population Affairs (OPA), Talking Matters is a promising group-level, two-pronged intervention tailored for urban Black and African American 14 to 19 year old adolescents who are recruited from school- and community-based settings in Philadelphia, PA. Grounded in Social Cognitive Theory, the Transtheoretical Model, and Self-Determination Theory, and using evidence-based Motivational Interviewing strategies, the primary goals of Talking Matters are to reduce adolescents' risk for teen and unplanned pregnancy, sexually transmitted infections (STIs) and HIV, and to strengthen protective factors improve optimal health.

The two prongs of Talking Matters include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT). An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. Adult participants of the LTRT training are not human subjects of the Talking Matters study.

Conditions

Pregnancy in Adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Talking Matters intervention

Talking Matters is a group-level, two-pronged intervention for Black and African American 14 to 19 year old adolescents recruited from school- and community-based settings in Philadelphia, PA. Goals are to reduce teens' risk for unplanned pregnancy, sexually transmitted infections, and HIV, and to strengthen protective factors to improve health. The two prongs include (1) an adolescent-focused five-session, group-level intervention called We Get to Choose (WGTC) covering sexual and reproductive health (SRH) knowledge and skills, decision making and self-worth, healthy relationships, substance use and mental health; and (2) an adult-focused three-session, group-level training called Let's Talk Real Talk (LTRT) to build SRH knowledge and skills to communicate with teens about SRH. An opportunity to connect WGTC participants to trusted adults who completed LTRT is provided during one facilitated session conducted each quarter. LTRT participants are not human subjects of the study.

Group Type: EXPERIMENTAL

Talking Matters

Intervention Type: BEHAVIORAL

Group-level, facilitator-led behavioral intervention for 14-19 year old Black and African American adolescents with an intergenerational component to reduce teen pregnancy, strengthen protective factors to improve optimal health, and increase access to trusted adults.

Control Group

Business as usual

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Talking Matters

Group-level, facilitator-led behavioral intervention for 14-19 year old Black and African American adolescents with an intergenerational component to reduce teen pregnancy, strengthen protective factors to improve optimal health, and increase access to trusted adults.

Intervention Type: BEHAVIORAL

Other Intervention Names

We Get to Choose; Let's Talk Real Talk

Eligibility Criteria

Inclusion Criteria

• Identifies as Black or African American
• 14 to 19 years old at baseline
• Lives in Philadelphia, PA
• English-speaking
• Able to or will be able to obtain access to the internet through a phone, tablet, or computer

Exclusion Criteria

• Does not identify as Black or African American
• Less than 14 years old or 20 years or older at baseline
• Does not live in Philadelphia, PA
• Unable to speak or understand English
• Unable to access internet through a phone, tablet, or computer

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Department of Health and Human Services

FED

Sponsor Role: collaborator

Public Health Management Corporation

OTHER

Sponsor Role: lead

Responsible Party

Archana LaPollo

Senior Project Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Archana B LaPollo, MPH

Role: PRINCIPAL_INVESTIGATOR

Public Health Management Corporation

Locations

Public Health Management Corporation

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

2003

Identifier Type: -

Identifier Source: org_study_id