Sexual BehaviorNCT02510209
Evaluation of the Teen Outreach Program in Hennepin County, Minnesota
A study testing Teen Outreach Program in people with Sexual Behavior and Pregnancy Early, run by Abt Associates at 1 site in United States.
Trial summary
This study tested the extent to which TOP®, when replicated with fidelity, produced impacts on sexual risk-taking behaviors in the short term and the longer term. Read more about this study
- Who is it for?
- Ages 12 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual Behavior, Pregnancy Early
- 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
- 1,644 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Nov 2014
- 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 12 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Enrolled in a study teacher's class at the time of the baseline survey
- Active parental consent and youth assent
Who cannot join
- Inability to complete survey in the languages provided
- Prior participation in TOP
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Human Services and Public Health Department
Minneapolis, Minnesota, 55415
About this study
Official title: Evaluation of the Teen Outreach Program in Hennepin County, Minnesota: Findings From the Replication of an Evidence-Based Teen Pregnancy Prevention Program
This study tested the extent to which TOP®, when replicated with fidelity, produced impacts on sexual risk-taking behaviors in the short term and the longer term.
Read the detailed description
This is a cluster randomized controlled trial. Teachers were randomized within schools to the treatment and control conditions. To assess the impact of offering TOP®, students were surveyed three times: at baseline, before the intervention began for the treatment group; 12 months after baseline (short-term impacts); and 24 months after baseline (long-term impacts). Baseline data and subsequent follow-up data were collected using a Web-based survey. Paper surveys were used as back-up for baseline data collection. The pooled survey data from two school-year cohorts (school years 2011-2012 and 2012-2013) were used to estimate program impacts using an intent-to-treat (ITT) analysis. Program fidelity and interview data were used to describe program implementation.TOP® was delivered in middle schools, high schools, alternative schools, and public charter schools in Hennepin County. It was implemented during school hours in classes that spanned an entire school year with the same cohort of students. The subject of the class in which TOP® was placed differed across schools (for example, social studies, study hall, health).
- Conditions
- Sexual Behavior, Pregnancy Early
- Being tested
- Teen Outreach Program
- Keywords
- Teen pregnancy
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen Outreach ProgramBehavioural
TOP® is a youth development and service learning program for youth ages 12 to 17 designed to reduce teenage pregnancy and increase school success by helping youth develop a positive self-image, life management skills, and realistic goals. The TOP® program model consists of three components implemented in school, after school, or in community settings over nine consecutive months: (1) weekly curriculum sessions, (2) community service learning (CSL), and (3) positive adult guidance and support. The TOP® Changing Scenes® curriculum is separated into four age- and stage-appropriate levels, which range from Level 1, typically for youth ages 12 or 13, to Level 4, typically for youth age 17.
| Study group | Role | What they receive |
|---|---|---|
| Teen Outreach Program | Experimental | Not described Receives: Behavioral: Teen Outreach Program |
| Control | No intervention | Business as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex in the last 90 days
Single dichotomous item on self-report questionnaire
Measured: 12 months after baseline
Secondary outcomes (5)
Sex without contraception in the last 90 days
Single dichotomous item on self-report questionnaire
Measured: 12 months after baseline
Sex in the last 90 days
Single dichotomous item on self-report questionnaire
Measured: 24 months after baseline
Sex without contraception in the last 90 days
Single dichotomous item on self-report questionnaire
Measured: 24 months after baseline
Ever had sex
This outcome was measured among the subgroup of participants who had never had sex at baseline. Single dichotomous item on self-report questionnaire.
Measured: 12 months after baseline
Ever had sex
This outcome was measured among the subgroup of participants who had never had sex at baseline. Single dichotomous item on self-report questionnaire.
Measured: 24 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startJul 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sexual BehaviorStudies 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
- None (open label)
- Enrolment
- 1,644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abt Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hennepin County Human Services and Public Health Department
- Responsible party
- Sponsor
- Investigators
- Kimberly Francis, PhD, Study director, Abt Associates Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02510209
- Sponsor's protocol ID
- TP1AH000078
- Status last verified
- Jul 2015
- First submitted
- 27 Jul 2015
- Last updated
- 29 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Francis, K., Woodford, M., and Kelsey, M. (2015). "Evaluation of the Teen Outreach Program in Hennepin County, MN: Findings from the Replication of an Evidence-Based Teen Pregnancy Prevention Program." Cambridge, MA: Abt Associates Inc.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Teen Outreach Program in Hennepin County, Minnesota: Findings From the Replication of an Evidence-Based Teen Pregnancy Prevention Program
- ClinicalTrials.gov ID
- NCT02510209
- Acronym / sponsor ID
- TP1AH000078
- Conditions
- Sexual Behavior, Pregnancy Early
- Keywords
- Teen pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,644 participants (actual)
- Lead sponsor
- Abt AssociatesIndustry (pharma, biotech, devices)
- Collaborators
- Hennepin County Human Services and Public Health Department
- Study start
- Jul 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 29 Jul 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.
This study tested the extent to which TOP®, when replicated with fidelity, produced impacts on sexual risk-taking behaviors in the short term and the longer term.
Detailed description
This is a cluster randomized controlled trial. Teachers were randomized within schools to the treatment and control conditions. To assess the impact of offering TOP®, students were surveyed three times: at baseline, before the intervention began for the treatment group; 12 months after baseline (short-term impacts); and 24 months after baseline (long-term impacts). Baseline data and subsequent follow-up data were collected using a Web-based survey. Paper surveys were used as back-up for baseline data collection. The pooled survey data from two school-year cohorts (school years 2011-2012 and 2012-2013) were used to estimate program impacts using an intent-to-treat (ITT) analysis. Program fidelity and interview data were used to describe program implementation.TOP® was delivered in middle schools, high schools, alternative schools, and public charter schools in Hennepin County. It was implemented during school hours in classes that spanned an entire school year with the same cohort of students. The subject of the class in which TOP® was placed differed across schools (for example, social studies, study hall, health).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen Outreach Program | Experimental | Behavioral: Teen Outreach Program |
| Control | No intervention | –Business as usual. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Enrolled in a study teacher's class at the time of the baseline survey
- Active parental consent and youth assent
Key exclusion criteria (2 listed)
- Inability to complete survey in the languages provided
- Prior participation in TOP
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 ProgramTOP® is a youth development and service learning program for youth ages 12 to 17 designed to reduce teenage pregnancy and increase school success by helping youth develop a positive self-image, life management skills, and realistic goals. The TOP® program model consists of three components implemented in school, after school, or in community settings over nine consecutive months: (1) weekly curriculum sessions, (2) community service learning (CSL), and (3) positive adult guidance and support. The TOP® Changing Scenes® curriculum is separated into four age- and stage-appropriate levels, which range from Level 1, typically for youth ages 12 or 13, to Level 4, typically for youth age 17. | Behavioural | Teen Outreach Program |
Primary outcome
Sex in the last 90 days
Time frame: 12 months after baseline
Single dichotomous item on self-report questionnaire
5 secondary outcomes
Sex without contraception in the last 90 days
Time frame: 12 months after baseline
Sex in the last 90 days
Time frame: 24 months after baseline
Sex without contraception in the last 90 days
Time frame: 24 months after baseline
Ever had sex
Time frame: 12 months after baseline
Ever had sex
Time frame: 24 months after baseline
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 29 Jul 2015.
- Results publicationFrancis, K., Woodford, M., and Kelsey, M. (2015). "Evaluation of the Teen Outreach Program in Hennepin County, MN: Findings from the Replication of an Evidence-Based Teen Pregnancy Prevention Program." Cambridge, MA: Abt Associates Inc.
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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.
Kimberly Francis, PhD study director
Abt Associates Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teen Outreach Program in people with Sexual Behavior and Pregnancy Early, run by Abt Associates 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 2 inclusion and 2 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 29 Jul 2015. 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?
Sex in the last 90 days (time frame: 12 months after baseline). 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 NCT02510209, which also lists 1 linked publication.
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 29 Jul 2015.