Unintended PregnancyNCT02519530
Multi-site Evaluation of an Evidence-based Positive Youth Development Program
A study testing Teen Outreach Program in people with Unintended Pregnancy and Adolescent Problem Behavior, run by University of South Florida.
Trial summary
Investigators are carrying out a study to assess the immediate and long-term effects of a positive youth development program (the Teen Outreach Program) on high school youth in Florida. Read more about this study
- Who is it for?
- Ages 13 to 22 yearsHealthy volunteers can take part
- Conditions the study is for
- Unintended Pregnancy, Adolescent Problem Behavior
- What is being tested?
- Teen Outreach Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,161 participants
- Where
- No sites listed yet
- Study dates
- Aug 2012to Jun 2015
- 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 22 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in a class selected for evaluation
- Had parental consent
- Proficient in English
- Capable of independently taking a paper and pencil survey
Who cannot join
- Not enrolled in a class randomly selected for the evaluation
- They joined a participating class after the completion of the parental consent process
- Not sufficiently proficient in English
- Could not independently take a paper and pencil survey
About this study
Official title: Multi-site Evaluation of an Evidence-based Positive Youth Development Program: a School-level, Longitudinal, Randomized Controlled Trial
Investigators are carrying out a study to assess the immediate and long-term effects of a positive youth development program (the Teen Outreach Program) on high school youth in Florida. This study will answer the following questions: What is the impact of the Teen Outreach Program on sexual activity and positive youth development at the end of the program and 10 months after the program?
Read the detailed description
Schools were randomly allocated to either the intervention or the control group. At treatment (intervention) schools, youth participated in TOP in addition to their Health, HOPE, Critical Thinking, Career Research, or Leadership class. At control (non-intervention) schools, youth simply participated in their business-as-usual Health, HOPE, Critical Thinking, Career Research, or Leadership class. Two cohorts of students were recruited for this study, the first cohort joined the study in August 2012 and the second cohort joined the study in August 2013. A survey was given to youth at both treatment and control schools. The paper-and-pencil survey took approximately 30 minutes and asked questions about youth school, grades, peers, health behaviors, and behaviors related to teen pregnancy, including what the participant believes and does in regards to sexual health. The survey was completely confidential and participant names were not linked to survey responses. All survey materials were pre-approved by school administration and the school district office. Participants will be asked to complete the a survey at pre-intervention, post-intervention, and 10-months post-intervention (Cohort 1 only)
- Conditions
- Unintended Pregnancy, Adolescent Problem Behavior
- Being tested
- Teen Outreach Program
- Keywords
- Positive Youth Development, Teen Outreach, Teen Pregnancy Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen Outreach ProgramBehavioural
The Teen Outreach Program (TOP) is a positive youth development program that uses weekly educational peer group sessions, Community Service Learning (CSL), and positive adult guidance to help youth in grades 6-12 build healthy behaviors, life skills, and a sense of purpose. For this study, TOP was implemented in traditional public high schools in Florida and delivered by local health department staff, who were trained and certified as TOP facilitators. Youth enrolled in these classes received the TOP intervention in addition to, not as a replacement for, all business-as-usual curriculum content.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Behavioral: Teen Outreach Program Receives: Behavioral: Teen Outreach Program |
| Comparison | No intervention | This group did not receive TOP, they received business as usual health curriculum offered through the public school system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants that report ever having sexual intercourse as measured by the second follow-up youth survey
What is the impact of TOP relative to business as usual on ever having sexual intercourse 10 months after the end of the program?
Measured: 10 months post program
Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the second follow-up youth survey
What is the impact of TOP relative to business as usual on ever having been pregnant or gotten someone pregnant 10 months after the end of the program?
Measured: 10 months post program
Secondary outcomes (2)
Number of participants that report ever having sexual intercourse as measured by the first follow-up youth survey
What is the impact of TOP relative to business as usual on ever having sexual intercourse at the end of the program?
Measured: Immediately post program
Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the first follow-up youth survey
What is the impact of TOP relative to business as usual on ever having been pregnant or gotten someone pregnant at the end of the program?
Measured: Immediately post program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2015 (estimated)
- Study startAug 2012
- Primary completionOct 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Unintended PregnancyStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 8,161 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Department of Health, The Office of Adolescent Health, HHS
- Responsible party
- Sponsor
- Investigators
- Ellen Daley, Ph.D, Principal investigator, University of South FloridaEric Buhi, Ph.D, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02519530
- Sponsor's protocol ID
- 5 TP1AH000017-04-00
- Status last verified
- Jul 2015
- First submitted
- 31 Jul 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Marhefka SL, Noble CA, Walsh-Buhi ER, Turner D, Mahony H, Singleton A, DeBate R, Daley EM. Key Considerations and Recommended Strategies for Conducting a School-Based Longitudinal RE-AIM Evaluation: Insights From a 28-School Cluster Randomized Trial. Health Promot Pract. 2023 Jan;24(1):160-171. doi: 10.1177/15248399211042339. Epub 2021 Oct 4.
PubMed 34605711Walsh-Buhi ER, Marhefka SL, Wang W, Debate R, Perrin K, Singleton A, Noble CA, Rahman S, Maness SB, Mahony H, Ziemba R, Malmi M, Marwah E, Hall K, Turner D, Blunt-Vinti H, Noble SM, Daley EM. The Impact of the Teen Outreach Program on Sexual Intentions and Behaviors. J Adolesc Health. 2016 Sep;59(3):283-290. doi: 10.1016/j.jadohealth.2016.05.007. Epub 2016 Jun 16.
PubMed 27318427
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-site Evaluation of an Evidence-based Positive Youth Development Program: a School-level, Longitudinal, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02519530
- Acronym / sponsor ID
- 5 TP1AH000017-04-00
- Conditions
- Unintended Pregnancy, Adolescent Problem Behavior
- Keywords
- Positive Youth Development, Teen Outreach, Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,161 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Collaborators
- Florida Department of Health, The Office of Adolescent Health, HHS
- Study start
- Aug 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 11 Aug 2015 (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.
Investigators are carrying out a study to assess the immediate and long-term effects of a positive youth development program (the Teen Outreach Program) on high school youth in Florida. This study will answer the following questions: What is the impact of the Teen Outreach Program on sexual activity and positive youth development at the end of the program and 10 months after the program?
Detailed description
Schools were randomly allocated to either the intervention or the control group. At treatment (intervention) schools, youth participated in TOP in addition to their Health, HOPE, Critical Thinking, Career Research, or Leadership class. At control (non-intervention) schools, youth simply participated in their business-as-usual Health, HOPE, Critical Thinking, Career Research, or Leadership class. Two cohorts of students were recruited for this study, the first cohort joined the study in August 2012 and the second cohort joined the study in August 2013. A survey was given to youth at both treatment and control schools. The paper-and-pencil survey took approximately 30 minutes and asked questions about youth school, grades, peers, health behaviors, and behaviors related to teen pregnancy, including what the participant believes and does in regards to sexual health. The survey was completely confidential and participant names were not linked to survey responses. All survey materials were pre-approved by school administration and the school district office. Participants will be asked to complete the a survey at pre-intervention, post-intervention, and 10-months post-intervention (Cohort 1 only)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Teen Outreach ProgramBehavioral: Teen Outreach Program |
| Comparison | No intervention | –This group did not receive TOP, they received business as usual health curriculum offered through the public school system |
Who may qualify
- Ages
- 13 to 22 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Enrolled in a class selected for evaluation
- Had parental consent
- Proficient in English
- Capable of independently taking a paper and pencil survey
Key exclusion criteria (4 listed)
- Not enrolled in a class randomly selected for the evaluation
- They joined a participating class after the completion of the parental consent process
- Not sufficiently proficient in English
- Could not independently take a paper and pencil survey
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 |
|---|---|---|
| Teen Outreach ProgramThe Teen Outreach Program (TOP) is a positive youth development program that uses weekly educational peer group sessions, Community Service Learning (CSL), and positive adult guidance to help youth in grades 6-12 build healthy behaviors, life skills, and a sense of purpose. For this study, TOP was implemented in traditional public high schools in Florida and delivered by local health department staff, who were trained and certified as TOP facilitators. Youth enrolled in these classes received the TOP intervention in addition to, not as a replacement for, all business-as-usual curriculum content. | Behavioural | Intervention |
Primary outcome
Number of participants that report ever having sexual intercourse as measured by the second follow-up youth survey
Time frame: 10 months post program
What is the impact of TOP relative to business as usual on ever having sexual intercourse 10 months after the end of the program?
Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the second follow-up youth survey
Time frame: 10 months post program
What is the impact of TOP relative to business as usual on ever having been pregnant or gotten someone pregnant 10 months after the end of the program?
2 secondary outcomes
Number of participants that report ever having sexual intercourse as measured by the first follow-up youth survey
Time frame: Immediately post program
Number of participants that report ever having been pregnant or gotten someone pregnant as measured by the first follow-up youth survey
Time frame: Immediately post program
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 11 Aug 2015.
- Derived from this study: PubMed 34605711Marhefka SL, Noble CA, Walsh-Buhi ER, Turner D, Mahony H, Singleton A, DeBate R, Daley EM. Key Considerations and Recommended Strategies for Conducting a School-Based Longitudinal RE-AIM Evaluation: Insights From a 28-School Cluster Randomized Trial. Health Promot Pract. 2023 Jan;24(1):160-171. doi: 10.1177/15248399211042339. Epub 2021 Oct 4.
- Derived from this study: PubMed 27318427Walsh-Buhi ER, Marhefka SL, Wang W, Debate R, Perrin K, Singleton A, Noble CA, Rahman S, Maness SB, Mahony H, Ziemba R, Malmi M, Marwah E, Hall K, Turner D, Blunt-Vinti H, Noble SM, Daley EM. The Impact of the Teen Outreach Program on Sexual Intentions and Behaviors. J Adolesc Health. 2016 Sep;59(3):283-290. doi: 10.1016/j.jadohealth.2016.05.007. Epub 2016 Jun 16.
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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.
Ellen Daley, Ph.D principal investigator
University of South Florida
Eric Buhi, Ph.D principal investigator
San Diego State University
Questions about this trial
What is this clinical trial studying?
A study testing Teen Outreach Program in people with Unintended Pregnancy and Adolescent Problem Behavior, run by University of South Florida.
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 4 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 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of participants that report ever having sexual intercourse as measured by the second follow-up youth survey (time frame: 10 months post program). 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?
On the ClinicalTrials.gov record for NCT02519530, which also lists 2 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 11 Aug 2015.