NCT04717596

Brief Summary

This study is a hybrid trial that examines both the clinical effectiveness and the implementation of BC4Teens Contraception Care. The investigators use a naturalistic one-group longitudinal study design to maximize feasibility and external validity, which is important for understanding implementation and effectiveness in real-world service delivery settings.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
455

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

April 7, 2021

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2023

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

October 10, 2024

Completed
Last Updated

October 10, 2024

Status Verified

July 1, 2024

Enrollment Period

2.3 years

First QC Date

January 13, 2021

Results QC Date

October 24, 2023

Last Update Submit

July 22, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Interest BC4Teens Care

    % participants who answer yes to the following question "Interest in learning more about contraception during your hospital stay". Investigators will calculate the percentage of participants who answer yes to the Interest in Contraption Initiation question.

    Baseline

Interventions

Healthcare providers will be trained in contraceptive counseling and provision.

Eligibility Criteria

Age14 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

female adolescents hospitalized for mental health disorder on Psychiatric Unit, Youth Crisis Stabilization Unit (YCSU), Psychiatric Crisis Department Extended Observation Care Unit, and Hospital Pediatrics service at Nationwide Children's Hospital

You may qualify if:

  • female adolescents, ages 14 and up, receiving care in Psychiatric Unit, Youth Crisis Stabilization Unit (YCSU), Psychiatric Crisis Department Extended Observation Care Unit, and Hospital Pediatrics service

You may not qualify if:

  • unable to consent due to mental health disorder, serious medical condition, non-English speaking, known pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Results Point of Contact

Title
Dr. Elise Berlan
Organization
Abigail Wexner Research Institute

Study Officials

  • Elise Berlan, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 13, 2021

First Posted

January 22, 2021

Study Start

April 7, 2021

Primary Completion

August 1, 2023

Study Completion

September 15, 2023

Last Updated

October 10, 2024

Results First Posted

October 10, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

IPD will not be shared outside of the research team.

Locations