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Completed

NCT Number: NCT04120376

Reducing Adolescent Pregnancy

This multi-site study is employing a brief contraception counseling intervention in the Emergency Department (ED) to shed light on factors that affect decision making as well as barriers and facilitators to conception initiation in the Emergency Department (ED) setting. The overarching goal of the study is to reduce unintended pregnancy among females ages 15 to 18 who present to the Emergency Department (ED).

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Key information

Age range

15 year–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Mercy Hospital, Kansas City, Missouri, United States

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About this study

This study is a prospective cohort study involving females who present to one of two emergency departments (ED) between the ages of 16 and 18, who are at risk of unintended pregnancy.

Our primary objective is to assess intention to initiate contraception ("high"=very/somewhat likely vs "low"=unsure/not likely/definitely not on Likert scale survey) among females aged 15 to 18 years who receive emergency department-based contraceptive counseling.

Our secondary objectives are as follows:

  • Among the same population, assess completion of a referral for any contraceptive care, defined as attendance at a referral site within 4 weeks after the index ED visit.
  • Assess the proportion who ultimately initiate contraception through electronic medical record documentation (i.e., visit note, procedure note, medication review) and participant report (follow-up calls).
  • Use qualitative interview methodology to explore attitudes, barriers, and facilitators that affect decisions to A) express intention to initiate contraception, B) complete a referral for contraceptive care, and C) ultimately initiate contraception among this unique group of high-risk adolescents.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Females aged 15-18 years who are at high-risk of pregnancy, defined as sexual activity within the last 6 months or likely future sexual activity.
  • Females who do not desire to become pregnant within the next year.
  • Eligible individuals must be proficient in speaking and reading in English.
  • Consent of the adolescent.

Exclusion criteria

  • Females who are currently using hormonal contraception or an intrauterine device.
  • Females who are pregnant.
  • Patient has a developmental delay limiting participation.
  • Patient is presenting in the ED after sexual assault.
  • Patient is too ill to be screened.

APPs: [no age limit]] Have been working in ED 6 months

Treatment and study plan

Contraception Counseling

Behavioral

Each participant will receive a 10 minute confidential contraception counseling session with an APP in the Emergency Department

Primary outcomes

  1. Intention to Initiate Contraception

    Time frame: up to 8 weeks

    Intention to initiate contraception at Emergency Department (ED) or follow-up visit from survey responses

Secondary outcomes

  1. Contraceptive Care Referral Completion

    Time frame: up to 8 weeks

    Participants completed a referral visit for any contraception care

  2. Initiation of Contraception

    Time frame: up to 12 weeks

    Participant has started contraception as evidenced by electronic medical record view and follow-up phone calls or surveys

Other outcomes

  1. Number of Unique Themes Affecting Decision-Making

    Time frame: up to 12 weeks

    Semistructured interviews were conducted and analyzed using grounded theory to elucidate the factors that affect decision-making around contraception initiation. Only a subset of enrolled adolescents participated in interviews which were optional (28 participants).

    Factors were based on a theoretical framework called eTPB, the ecologically expanded theory of planned behavior, relying on attitudes, subjective norms, community, health care and perceived behavioral control factors to explain behavior. Interview analysis yielded the following factors: concerns about contraception side effects and safety, previous experiences with contraception, reasons for using contraception, peer, family and partner influence, social media, pregnancy rates, and access to contraception eduction, provider encounters, confidence in contraception decision making and knowledge, and the ED session characteristics; all of the above factors corresponded with a construct from eTPB.

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • Children's Mercy Hospital Kansas City
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Pittsburgh

Registry information

Official study title

An Emergency Department-Based Study to Reduce Adolescent Pregnancy

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 9, 2019
Registry last updated
Feb 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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