Brief Intervention for Teen Pregnancy Prevention

NCT02816424 | Completed

• 1 other identifier: TP2AH000028
• Study Type: interventional
• Target: 447
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Teen Pregnancy Prevention

Keywords

Screening and Brief Intervention; Motivational Interviewing; Teen Pregnancy Prevention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Proportion of participants endorsing unprotected sex at 9 month follow up

  9-Month Endpoint

• Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 9 month follow up

  9-Month Endpoint

Study Arms (2)

Brief Motivational Interviewing

EXPERIMENTAL

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)

Control

NO INTERVENTION

Interventions

Teens Exploring and Managing Prevention Options (TEMPO) BEHAVIORAL

Brief Motivational Interviewing

Eligibility Criteria

• Age: 13 Years - 19 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of New Mexico: lead
• Department of Health and Human Services: collaborator

Study Sites (1)

The University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Study Officials

• Jennifer E Hettema, PhD

  The University of New Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 28, 2016
• Study Start: November 11, 2015
• Primary Completion: August 20, 2021
• Study Completion: August 20, 2021
• Last Updated: May 24, 2022

Record last verified: 2020-04

Locations

US (1)