Pregnancy in AdolescenceNCT04120376

Reducing Adolescent Pregnancy

A study testing Contraception Counseling in people with Pregnancy in Adolescence and Counseling, run by Children's Hospital of Philadelphia at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 15 to 18 years, women onlyHealthy volunteers can take part
Conditions the study is for: Pregnancy in Adolescence, Counseling, Contraception Behavior
What is being tested?: Contraception Counseling
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 2 sitesUnited States
Study dates: 13 Nov 2019to 30 Apr 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 15 to 18 years
Women only
Healthy volunteers accepted
Child, Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: An Emergency Department-Based Study to Reduce Adolescent Pregnancy

Read the detailed description

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.

Conditions: Pregnancy in Adolescence, Counseling, Contraception Behavior
Being tested: Contraception Counseling
Keywords: Contraception counseling, Adolescent pregnancy, Contraception initiation
Medical subject headings: Contraception Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04120376
Study group	Role	What they receive
Counseling Intervention	Experimental	All participants will receive contraception counseling by study Advanced Practice Providers (APPs) Receives: Behavioral: Contraception Counseling

What is being measured

The primary outcome is the main question the study is designed to answer.

Intention to Initiate Contraception
Intention to initiate contraception at Emergency Department (ED) or follow-up visit from survey responses
Measured: up to 8 weeks

Secondary outcomes (2)

Contraceptive Care Referral Completion
Participants completed a referral visit for any contraception care
Measured: up to 8 weeks
Initiation of Contraception
Participant has started contraception as evidenced by electronic medical record view and follow-up phone calls or surveys
Measured: up to 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Nov 201930 Apr 2021

First posted9 Oct 2019
Study start13 Nov 2019
Primary completion17 Feb 2021
Study completion30 Apr 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (57)Papers the sponsor has linked to this study.
Other trials for Pregnancy in AdolescenceStudies of the same condition, open and under way.
More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Model description: 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.
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04120376
Sponsor's protocol ID: 19-016314
Other IDs: 5R21HD095096-02
Status last verified: Jan 2023
First submitted: 7 Oct 2019
Last updated: 3 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Only the site PIs and team will have access to study data.

Publications

Hoffman SD, Maynard RA. Kids having kids: Economic costs & social consequences of teen pregnancy. The Urban Institute; 2008.
Teen Childbearing Cost Taxpayers $9.4 Billion in 2010 [press release]. 2013.
Miller E, Goldstein S, McCauley HL, Jones KA, Dick RN, Jetton J, Silverman JG, Blackburn S, Monasterio E, James L, Tancredi DJ. A school health center intervention for abusive adolescent relationships: a cluster RCT. Pediatrics. 2015 Jan;135(1):76-85. doi: 10.1542/peds.2014-2471. Epub 2014 Dec 22.
PubMed 25535265
Guttmacher Institute. Adolescent pregnancy and its outcomes across countries. Fact Sheet; August 2015. https://www.guttmacher.org/fact-sheet/adolescent-pregnancy-and-its-outcomes-across-countries; accessed January 12, 2018.
Lindberg L, Santelli J, Desai S. Understanding the Decline in Adolescent Fertility in the United States, 2007-2012. J Adolesc Health. 2016 Nov;59(5):577-583. doi: 10.1016/j.jadohealth.2016.06.024. Epub 2016 Aug 29.
PubMed 27595471
Santelli JS, Lindberg LD, Finer LB, Singh S. Explaining recent declines in adolescent pregnancy in the United States: the contribution of abstinence and improved contraceptive use. Am J Public Health. 2007 Jan;97(1):150-6. doi: 10.2105/AJPH.2006.089169. Epub 2006 Nov 30.
PubMed 17138906
Sonfield A, Hasstedt K, Gold RB. Moving Forward: Family Planning in the Era of Health Reform, New York: Guttmacher Institute, 2014. https://www.guttmacher.org/report/moving-forward-family-planning-era-health-reform; accessed March 1, 2018.
Frost JJ, Darroch JE, Remez L. Improving contraceptive use in the United States. Issues Brief (Alan Guttmacher Inst). 2008;(1):1-8.
PubMed 18561392
Santelli JS, Morrow B, Anderson JE, Lindberg LD. Contraceptive use and pregnancy risk among U.S. high school students, 1991-2003. Perspect Sex Reprod Health. 2006 Jun;38(2):106-11. doi: 10.1363/psrh.38.106.06.
PubMed 16772192
Fine LC, Mollen CJ. A pilot study to assess candidacy for emergency contraception and interest in sexual health education in a pediatric emergency department population. Pediatr Emerg Care. 2010 Jun;26(6):413-6. doi: 10.1097/PEC.0b013e3181e0578f.
PubMed 20502389
Ziv A, Boulet JR, Slap GB. Emergency department utilization by adolescents in the United States. Pediatrics. 1998 Jun;101(6):987-94. doi: 10.1542/peds.101.6.987.
PubMed 9606224
Chernick L, Kharbanda EO, Santelli J, Dayan P. Identifying adolescent females at high risk of pregnancy in a pediatric emergency department. J Adolesc Health. 2012 Aug;51(2):171-8. doi: 10.1016/j.jadohealth.2011.11.023. Epub 2012 Apr 4.
PubMed 22824448
Miller MK, Pickett M, Leisner K, Sherman AK, Humiston SG. Sexual health behaviors, preferences for care, and use of health services among adolescents in pediatric emergency departments. Pediatr Emerg Care. 2013 Aug;29(8):907-11. doi: 10.1097/PEC.0b013e31829ec244.
PubMed 23903671
Walton MA, Resko S, Whiteside L, Chermack ST, Zimmerman M, Cunningham RM. Sexual risk behaviors among teens at an urban emergency department: relationship with violent behaviors and substance use. J Adolesc Health. 2011 Mar;48(3):303-5. doi: 10.1016/j.jadohealth.2010.07.005.
PubMed 21338903
Jaccard J, Levitz N. Counseling adolescents about contraception: towards the development of an evidence-based protocol for contraceptive counselors. J Adolesc Health. 2013 Apr;52(4 Suppl):S6-13. doi: 10.1016/j.jadohealth.2013.01.018.
PubMed 23535060

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Pregnancy in Adolescence trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Emergency Department-Based Study to Reduce Adolescent Pregnancy
ClinicalTrials.gov ID: NCT04120376
Acronym / sponsor ID: 19-016314
Conditions: Pregnancy in Adolescence, Counseling, Contraception Behavior
Keywords: Contraception counseling, Adolescent pregnancy, Contraception initiation
Study type: Interventional
Recruitment status: Completed
Enrolment: 144 participants (actual)
Lead sponsor: Children's Hospital of PhiladelphiaUniversity, hospital or other
Collaborators: Children's Mercy Hospital Kansas City, University of Pittsburgh, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study start: 13 Nov 2019 (actual)
Primary completion: 17 Feb 2021 (actual)
Study completion: 30 Apr 2021 (actual)
First posted: 9 Oct 2019 (actual)
Results: Posted 3 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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 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.

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: 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.

Arm	Type	Receives
Counseling Intervention	Experimental	Behavioral: Contraception CounselingAll participants will receive contraception counseling by study Advanced Practice Providers (APPs)

Who may qualify

Ages: 15 to 18 years
Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Contraception CounselingEach participant will receive a 10 minute confidential contraception counseling session with an APP in the Emergency Department	Behavioural	Counseling Intervention

Primary outcome

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

2 secondary outcomes

Contraceptive Care Referral Completion
Time frame: up to 8 weeks
Initiation of Contraception
Time frame: up to 12 weeks

Results and safety

Results posted to the registry on 3 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Contraception Counseling in ED	108	99
APP Contraception Counseling Training	27	27

Primary outcome: Intention to Initiate Contraception

Time frame: up to 8 weeks. Count of participants. Unit: Participants

Measure	Adolescent Counseling Intervention n = 96
Value	59

Population analysed: Those who reported "high intention" to initiate contraception

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to eight weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Counseling Intervention	0 of 99 (0%)	0 of 99 (0%)	0 of 99
APP Contraception Counseling Training	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundHoffman SD, Maynard RA. Kids having kids: Economic costs & social consequences of teen pregnancy. The Urban Institute; 2008.
BackgroundTeen Childbearing Cost Taxpayers $9.4 Billion in 2010 [press release]. 2013.
Background: PubMed 25535265Miller E, Goldstein S, McCauley HL, Jones KA, Dick RN, Jetton J, Silverman JG, Blackburn S, Monasterio E, James L, Tancredi DJ. A school health center intervention for abusive adolescent relationships: a cluster RCT. Pediatrics. 2015 Jan;135(1):76-85. doi: 10.1542/peds.2014-2471. Epub 2014 Dec 22.
BackgroundGuttmacher Institute. Adolescent pregnancy and its outcomes across countries. Fact Sheet; August 2015. https://www.guttmacher.org/fact-sheet/adolescent-pregnancy-and-its-outcomes-across-countries; accessed January 12, 2018.
Background: PubMed 27595471Lindberg L, Santelli J, Desai S. Understanding the Decline in Adolescent Fertility in the United States, 2007-2012. J Adolesc Health. 2016 Nov;59(5):577-583. doi: 10.1016/j.jadohealth.2016.06.024. Epub 2016 Aug 29.
Background: PubMed 17138906Santelli JS, Lindberg LD, Finer LB, Singh S. Explaining recent declines in adolescent pregnancy in the United States: the contribution of abstinence and improved contraceptive use. Am J Public Health. 2007 Jan;97(1):150-6. doi: 10.2105/AJPH.2006.089169. Epub 2006 Nov 30.
BackgroundSonfield A, Hasstedt K, Gold RB. Moving Forward: Family Planning in the Era of Health Reform, New York: Guttmacher Institute, 2014. https://www.guttmacher.org/report/moving-forward-family-planning-era-health-reform; accessed March 1, 2018.
Background: PubMed 18561392Frost JJ, Darroch JE, Remez L. Improving contraceptive use in the United States. Issues Brief (Alan Guttmacher Inst). 2008;(1):1-8.
Background: PubMed 16772192Santelli JS, Morrow B, Anderson JE, Lindberg LD. Contraceptive use and pregnancy risk among U.S. high school students, 1991-2003. Perspect Sex Reprod Health. 2006 Jun;38(2):106-11. doi: 10.1363/psrh.38.106.06.
Background: PubMed 20502389Fine LC, Mollen CJ. A pilot study to assess candidacy for emergency contraception and interest in sexual health education in a pediatric emergency department population. Pediatr Emerg Care. 2010 Jun;26(6):413-6. doi: 10.1097/PEC.0b013e3181e0578f.
Background: PubMed 9606224Ziv A, Boulet JR, Slap GB. Emergency department utilization by adolescents in the United States. Pediatrics. 1998 Jun;101(6):987-94. doi: 10.1542/peds.101.6.987.
Background: PubMed 22824448Chernick L, Kharbanda EO, Santelli J, Dayan P. Identifying adolescent females at high risk of pregnancy in a pediatric emergency department. J Adolesc Health. 2012 Aug;51(2):171-8. doi: 10.1016/j.jadohealth.2011.11.023. Epub 2012 Apr 4.
Individual participant dataSharing planned: No. Only the site PIs and team will have access to study data.

Related trials for Pregnancy in Adolescence

RecruitingPhase 2
HMBeacon: A Phase 2 Study to Evaluate ALN-6400 in Adult and Adolescent Female Patients With VWD and HMB
Von Willebrand Disease (VWD), Heavy Menstrual Bleeding (HMB)
RecruitingEarly Phase 1
Identifying Oxytocin Deficiency in Pediatric Patients With Pituitary Disease
Arginine Vasopressin Deficiency, Oxytocin Deficiency
RecruitingPhase 3
A Study to See if Tolvaptan is Safe in Infants and Children Who at Enrollment Are 28 Days to Less Than 18 Years Old With Autosomal Recessive Polycystic Kidney Disease (ARPKD)
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RecruitingPhase 2
Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Cynthia J Mollen, MD, MSCE principal investigator

Children's Hospital of Philadelphia

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Contraception Counseling in people with Pregnancy in Adolescence and Counseling, run by Children's Hospital of Philadelphia at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intention to Initiate Contraception (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04120376, which also lists 57 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.