Teen Pregnancy PreventionTEMPONCT02816424
Brief Intervention for Teen Pregnancy Prevention
A study testing Teens Exploring and Managing Prevention Options (TEMPO) in people with Teen Pregnancy Prevention, run by University of New Mexico at 1 site in United States.
Trial summary
Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine recommend that teen health providers screen for sexual risk behaviors and provide education and counseling to those at risk, there are currently no specific guidelines or protocols available to guide such practices, nor have there… Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Teen Pregnancy Prevention
- What is being tested?
- Teens Exploring and Managing Prevention Options (TEMPO)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 447 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2015to 20 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Aged 13-19
- Self-reported past year unprotected sex
- Can read and speak English
- Willing to be contacted for follow-up
Who cannot join
- Current use of long-acting reversible contraceptives
- Self-reported pregnancy or pregnancy discovered during optional medical contraception consultation
- Expressed suicidality
- Obvious cognitive impairment
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of New Mexico
Albuquerque, New Mexico, 87131
About this study
Official title: Prevention of Teen Pregnancy Through Screening and Brief Intervention in Primary Care
Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine recommend that teen health providers screen for sexual risk behaviors and provide education and counseling to those at risk, there are currently no specific guidelines or protocols available to guide such practices, nor have there been any rigorous evaluations of efficacy. Preventing teen pregnancy through brief intervention in primary care holds the promise to have a significant public health impact and reduce health disparities by engaging, educating, and motivating the majority of teens who visit a primary care setting each year. In the current study, we seek to rigorously evaluate the impact of brief intervention vs. informational control on unprotected sexual intercourse among teens with past year unprotected sex at two primary care clinics serving predominately underserved, minority populations in New Mexico. The target population for the current study will be 1350 male and female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the Albuquerque Job Corps Wellness Center. Extensive formative work involving the study population will be conducted prior to the trial to refine the motivational interviewing-based brief intervention. Eligible youth will be randomly assigned to brief intervention or an informational control condition, in addition to regularly offered medically-based contraception consultation and prescription services. Follow-ups at 3- and 9- months will compare rates of unprotected sex and acceptance of long-acting reversible contraceptives. Brief education and counseling interventions could be feasibly implemented during the greater than eight preventive and acute primary care visits that the average US adolescent attends during their teen years. Such an approach could conserve valuable resources required by more intensive interventions for nonresponsive teens with greater need. Furthermore, social determinants of health, such as poverty and race, that may reduce access to more extensive psychosocial interventions, are less likely to prevent access to primary care, increasing health equity.
- Conditions
- Teen Pregnancy Prevention
- Being tested
- Teens Exploring and Managing Prevention Options (TEMPO)
- Keywords
- Screening and Brief Intervention, Motivational Interviewing, Teen Pregnancy Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teens Exploring and Managing Prevention Options (TEMPO)Behavioural
| Study group | Role | What they receive |
|---|---|---|
| Brief Motivational Interviewing | Experimental | Principles and skills of motivational interviewing will be used with participants assigned to brief intervention. These participants will receive feedback that they are at risk for unintended pregnancy. They will receive information on the likelihood of pregnancy given their self-reported frequency of unprotected sex. They will be given information regarding negative consequences associated with teen pregnancy. They will be provided with information on the chances of pregnancy with abstinence, condom use, oral contraceptives, and Long Acting Reversible Contraceptives (LARC). Following information exchange, participants who are high in readiness to change will engage in action planning, whereby a specific plan for reducing risk for unintended pregnancy will be collaboratively developed with the interventionist. Patients who are low in readiness to change will complete a motivational interviewing-based roadmap activity that is designed to strategically evoke motivational speech. Receives: Behavioral: Teens Exploring and Managing Prevention Options (TEMPO) |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants endorsing unprotected sex at 3 month follow up
All participants
Measured: 3-Month Endpoint
Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 3 month follow up
Among female participants
Measured: 3-Month Endpoint
Secondary outcomes (2)
Proportion of participants endorsing unprotected sex at 9 month follow up
All participants
Measured: 9-Month Endpoint
Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 9 month follow up
Among female participants
Measured: 9-Month Endpoint
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study start11 Nov 2015
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teen Pregnancy PreventionStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 447 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Sponsor
- Investigators
- Jennifer E Hettema, PhD, Principal investigator, The University of New Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816424
- Sponsor's protocol ID
- TP2AH000028
- Acronym
- TEMPO
- Status last verified
- Apr 2020
- First submitted
- 9 Jun 2016
- Last updated
- 24 May 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Teen Pregnancy Through Screening and Brief Intervention in Primary Care
- ClinicalTrials.gov ID
- NCT02816424
- Acronym / sponsor ID
- TEMPO / TP2AH000028
- Conditions
- Teen Pregnancy Prevention
- Keywords
- Screening and Brief Intervention, Motivational Interviewing, Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 447 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 11 Nov 2015 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 28 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Although the Academy of Pediatrics and the Society for Adolescent Health and Medicine recommend that teen health providers screen for sexual risk behaviors and provide education and counseling to those at risk, there are currently no specific guidelines or protocols available to guide such practices, nor have there been any rigorous evaluations of efficacy. Preventing teen pregnancy through brief intervention in primary care holds the promise to have a significant public health impact and reduce health disparities by engaging, educating, and motivating the majority of teens who visit a primary care setting each year. In the current study, we seek to rigorously evaluate the impact of brief intervention vs. informational control on unprotected sexual intercourse among teens with past year unprotected sex at two primary care clinics serving predominately underserved, minority populations in New Mexico. The target population for the current study will be 1350 male and female teens, aged 13-19, from the Atrisco Center for Family and Community Health and the Albuquerque Job Corps Wellness Center. Extensive formative work involving the study population will be conducted prior to the trial to refine the motivational interviewing-based brief intervention. Eligible youth will be randomly assigned to brief intervention or an informational control condition, in addition to regularly offered medically-based contraception consultation and prescription services. Follow-ups at 3- and 9- months will compare rates of unprotected sex and acceptance of long-acting reversible contraceptives. Brief education and counseling interventions could be feasibly implemented during the greater than eight preventive and acute primary care visits that the average US adolescent attends during their teen years. Such an approach could conserve valuable resources required by more intensive interventions for nonresponsive teens with greater need. Furthermore, social determinants of health, such as poverty and race, that may reduce access to more extensive psychosocial interventions, are less likely to prevent access to primary care, increasing health equity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brief Motivational Interviewing | Experimental | Behavioral: Teens Exploring and Managing Prevention Options (TEMPO)Principles and skills of motivational interviewing will be used with participants assigned to brief intervention. These participants will receive feedback that they are at risk for unintended pregnancy. They will receive information on the likelihood of pregnancy given their self-reported frequency of unprotected sex. They will be given information regarding negative consequences associated with teen pregnancy. They will be provided with information on the chances of pregnancy with abstinence, condom use, oral contraceptives, and Long Acting Reversible Contraceptives (LARC). Following information exchange, participants who are high in readiness to change will engage in action planning, whereby a specific plan for reducing risk for unintended pregnancy will be collaboratively developed with the interventionist. Patients who are low in readiness to change will complete a motivational interviewing-based roadmap activity that is designed to strategically evoke motivational speech. |
| Control | No intervention | – |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Aged 13-19
- Self-reported past year unprotected sex
- Can read and speak English
- Willing to be contacted for follow-up
Key exclusion criteria (5 listed)
- Current use of long-acting reversible contraceptives
- Self-reported pregnancy or pregnancy discovered during optional medical contraception consultation
- Expressed suicidality
- Obvious cognitive impairment
- Inability to provide informed consent
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 |
|---|---|---|
| Teens Exploring and Managing Prevention Options (TEMPO) | Behavioural | Brief Motivational Interviewing |
Primary outcome
Proportion of participants endorsing unprotected sex at 3 month follow up
Time frame: 3-Month Endpoint
All participants
Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 3 month follow up
Time frame: 3-Month Endpoint
Among female participants
2 secondary outcomes
Proportion of participants endorsing unprotected sex at 9 month follow up
Time frame: 9-Month Endpoint
Proportion of participants endorsing acceptance of Long Acting Reversible Contraception (LARC) at 9 month follow up
Time frame: 9-Month Endpoint
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2022.
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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.
Jennifer E Hettema, PhD principal investigator
The University of New Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teens Exploring and Managing Prevention Options (TEMPO) in people with Teen Pregnancy Prevention, run by University of New Mexico at 1 site 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 5 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 24 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Proportion of participants endorsing unprotected sex at 3 month follow up (time frame: 3-Month Endpoint). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 May 2022.