Reducing Adolescent Pregnancy

NCT04120376 | Completed Results DMC

• 2 other identifiers: 19-0163145R21HD095096-02
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Pregnancy in Adolescence; Counseling; Contraception Behavior

Keywords

Contraception counseling; Adolescent pregnancy; Contraception initiation

Outcome Measures

Primary Outcomes (1)

• Intention to Initiate Contraception

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

  up to 8 weeks

Secondary Outcomes (2)

• Contraceptive Care Referral Completion

  up to 8 weeks

• Initiation of Contraception

  up to 12 weeks

Other Outcomes (1)

• Number of Unique Themes Affecting Decision-Making

  up to 12 weeks

Study Arms (1)

Counseling Intervention

EXPERIMENTAL

All participants will receive contraception counseling by study Advanced Practice Providers (APPs)

Behavioral: Contraception Counseling

Interventions

Contraception Counseling BEHAVIORAL

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

Counseling Intervention

Eligibility Criteria

• Age: 15 Years - 18 Years
• Gender Eligibility Details: Individuals who identify as females and are at risk of getting pregnant.
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (2)

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (57)

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MeSH Terms

Conditions

Contraception Behavior

Condition Hierarchy (Ancestors)

Reproductive Behavior; Behavior

Limitations and Caveats

Coronavirus (COVID) 19 occurred during the study recruitment period and impacted the duration of time needed to reach our recruitment goals, and our ability to reach our initial recruitment goals. The sample size was recalculated to establish a suitable reduced sample size achievable within the confines of the study enrollment period and study budget.

Results Point of Contact

• Title: Dr. Cynthia Mollen
• Organization: Children's Hospital of Philadelphia

mollenc@chop.edu

2153701217

Study Officials

• Cynthia J Mollen, MD, MSCE

  Children's Hospital of Philadelphia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Contraception counseling will occur for all adolescent participants and APPs will be enrolled to conduct counseling. The number of participants enrolled includes the final number of participants including adolescent and APPs.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: November 13, 2019
• Primary Completion: February 17, 2021
• Study Completion: April 30, 2021
• Last Updated: February 3, 2023
• Results First Posted: February 3, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)