Reducing Adolescent Pregnancy in the Emergency Department

NCT04744155 | Completed Results

• 2 other identifiers: STUDY000011691R21HD098086-01A1
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

Brief Summary

A multi-site randomized trial. Adolescents enrolled in this Clinical Trial will be enrolled into one of two arms. Adolescents in both arms will receive motivational interviewing enhanced counseling and a referral for follow up care. Those randomized in the Multi-level intervention arm will be offered immediate Emergency Department based contraception in addition to receiving a warm referral (providing help with scheduling follow-up care).

Conditions

Contraception; Adolescent Behavior; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Adolescent Feasibility of Intervention

  The intervention will be deemed feasible if the median score across all items is ≥ 3. Individual responses range from 1 to 5. Higher scores indicate greater feasibility using the investigator created Feasibility Assessment.

  1 visit on day 1

Study Arms (2)

Multi-Level Intervention

EXPERIMENTAL

All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral.Those randomized to MLI will be offered immediate, ED-based contraception (i.e., oral pill, transdermal patch, vaginal ring, injection, subdermal implant) in addition to receive a warm referral (provider helping to schedule follow-up appointment) to follow-up on selected method (or to initiate in clinic, if preferred)

Behavioral: Multi-Level Intervention

Enhanced Standard of Care

ACTIVE COMPARATOR

All adolescents receive the Motivational Interviewing (MI) enhanced counseling and clinic referral. eSOC participants may obtain contraception only at the referral.

Behavioral: Enhanced Standard of Care

Interventions

Multi-Level Intervention BEHAVIORAL

Behavioral intervention that assesses uptake of contraception and seeks follow-up care.

Multi-Level Intervention

Enhanced Standard of Care BEHAVIORAL

Behavioral intervention that assesses uptake of contraception from follow-up care.

Enhanced Standard of Care

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Females who report past/anticipated intercourse with a male partner within previous year or intent to be sexually active with a male partner in next few months
• Do not desire pregnancy
• Not using intrauterine device (IUD) or Sub-dermal Implant
• English-speaking

You may not qualify if:

• Females who report current pregnancy or have positive urine pregnancy test
• Patient has a developmental delay limiting participation
• Patient is presenting in the ED after sexual assault
• Patient is too ill to be screened

Sponsors & Collaborators

• Children's Mercy Hospital Kansas City: lead
• National Institutes of Health (NIH): 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

MeSH Terms

Conditions

Adolescent Behavior; Emergencies

Condition Hierarchy (Ancestors)

Behavior; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Melissa K. Miller MD
• Organization: Children's Mercy Kansas City

mmiller@cmh.edu

8162343430

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will not be aware.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study Principal Investigator

Model Details: Adolescents will be enrolled into one of two arms: The Multi-level intervention (MLI) or Enhanced Standard of Care (eSOC). Adolescents in both arms will receive motivational interviewing enhanced counseling and a referral for follow up care. Those randomized in the MLI arm will be offered immediate ED-based contraception in addition to receiving a warm referral (providing help with scheduling follow-up care)

Study Record Dates

• First Submitted: December 28, 2020
• First Posted: February 8, 2021
• Study Start: May 12, 2021
• Primary Completion: October 31, 2022
• Study Completion: May 1, 2023
• Last Updated: September 28, 2023
• Results First Posted: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP

Locations

US (2)