Brief Intervention for Teen Pregnancy Prevention (TEMPO)

Prevention of Teen Pregnancy Through Screening and Brief Intervention in Primary Care

Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine recommend that teen health providers screen for sexual risk behaviors and provide education and counseling to those at risk, there are currently no specific guidelines or protocols available to guide such practices, nor have there been any rigorous evaluations of efficacy. Preventing teen pregnancy through brief intervention in primary care holds the promise to have a significant public health impact and reduce health disparities by engaging, educating, and motivating the majority of teens who visit a primary care setting each year. In the current study, we seek to rigorously evaluate the impact of brief intervention vs. informational control on unprotected sexual intercourse among teens with past year unprotected sex at two primary care clinics serving predominately underserved, minority populations in New Mexico. The target population for the current study will be 1350 male and female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the Albuquerque Job Corps Wellness Center. Extensive formative work involving the study population will be conducted prior to the trial to refine the motivational interviewing-based brief intervention. Eligible youth will be randomly assigned to brief intervention or an informational control condition, in addition to regularly offered medically-based contraception consultation and prescription services. Follow-ups at 3- and 9- months will compare rates of unprotected sex and acceptance of long-acting reversible contraceptives. Brief education and counseling interventions could be feasibly implemented during the greater than eight preventive and acute primary care visits that the average US adolescent attends during their teen years. Such an approach could conserve valuable resources required by more intensive interventions for nonresponsive teens with greater need. Furthermore, social determinants of health, such as poverty and race, that may reduce access to more extensive psychosocial interventions, are less likely to prevent access to primary care, increasing health equity.

Study Overview

• Status: Completed
• Conditions: Teen Pregnancy Prevention
• Intervention / Treatment: Behavioral: Teens Exploring and Managing Prevention Options (TEMPO)

• Study Type: Interventional
• Enrollment (Actual): 447
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • The University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 13-19
• Self-reported past year unprotected sex
• Can read and speak English
• Willing to be contacted for follow-up

Exclusion Criteria:

• Current use of long-acting reversible contraceptives
• Self-reported pregnancy or pregnancy discovered during optional medical contraception consultation
• Expressed suicidality
• Obvious cognitive impairment
• Inability to provide informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Brief Motivational Interviewing; Principles and skills of motivational interviewing will be used with participants assigned to brief intervention. These participants will receive feedback that they are at risk for unintended pregnancy. They will receive information on the likelihood of pregnancy given their self-reported frequency of unprotected sex. They will be given information regarding negative consequences associated with teen pregnancy. They will be provided with information on the chances of pregnancy with abstinence, condom use, oral contraceptives, and Long Acting Reversible Contraceptives (LARC). Following information exchange, participants who are high in readiness to change will engage in action planning, whereby a specific plan for reducing risk for unintended pregnancy will be collaboratively developed with the interventionist. Patients who are low in readiness to change will complete a motivational interviewing-based roadmap activity that is designed to strategically evoke motivational speech.	Behavioral: Teens Exploring and Managing Prevention Options (TEMPO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants endorsing unprotected sex at 3 month follow up	All participants	3-Month Endpoint
Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 3 month follow up	Among female participants	3-Month Endpoint

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants endorsing unprotected sex at 9 month follow up	All participants	9-Month Endpoint
Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 9 month follow up	Among female participants	9-Month Endpoint

Collaborators and Investigators

• Sponsor: University of New Mexico
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: Jennifer E Hettema, PhD, The University of New Mexico

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2015
• Primary Completion (Actual): August 20, 2021
• Study Completion (Actual): August 20, 2021

Study Registration Dates

• First Submitted: June 9, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimate): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): May 24, 2022
• Last Update Submitted That Met QC Criteria: May 23, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Motivational Interviewing; Screening and Brief Intervention; Teen Pregnancy Prevention
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; TEMPO
• Other Study ID Numbers: TP2AH000028