Sexual BehaviorNCT02548871
Evaluation of the Teen Outreach Program in Chicago Public Schools
A study testing Teen Outreach Program in people with Sexual Behavior, run by Chapin Hall at the University of Chicago.
Trial summary
The purpose of this study was to determine the impact of TOP® on sexual health behavior. Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Sexual 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
- 12,253 participants
- Where
- No sites listed yet
- Study dates
- Sep 2010to Aug 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 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- First-time 9th grade student
- Passive parental consent and student assent
Who cannot join
- Inability to complete survey in languages provided
About this study
Official title: Evaluation of the Teen Outreach Program in Chicago Public Schools: Replication of an Evidence-Based Teen Pregnancy Prevention Program
The purpose of this study was to determine the impact of TOP® on sexual health behavior.
Read the detailed description
The cluster-randomized study was conducted in 9th grade classrooms in Chicago Public Schools (CPS) with equal number of schools randomized to intervention and comparison groups for two cohort years. Students were administered a scannable paper survey at three time points: baseline, post-program and 1-year post program. The primary impact analysis used an intent-to-treat approach. Implementation of TOP® was assessed by conducting classroom observations. TOP® was delivered in a variety of classroom settings over the school year by facilitators from CPS and partner organizations.
- Conditions
- Sexual Behavior
- Being tested
- Teen Outreach Program
- 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 positive youth development and service learning program for youth ages 12 to 17, and its Changing Scenes curriculum is separated into age appropriate levels. The program uses an approach that involves a caring adult, positive self-efficacy, future planning and goal setting and life management skills to to reduce risky sexual behavior and improve school outcomes. TOP® is designed to be delivered in weekly sessions over 9 months and includes community service learning.
| Study group | Role | What they receive |
|---|---|---|
| Teen Outreach Program | Experimental | Teen Outreach Program Receives: Behavioral: Teen Outreach Program |
| Comparison | No intervention | Business as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sex without a condom in the last 90 days
Dichotomous indicator from self-report survey
Measured: 9 months after baseline
Secondary outcomes (3)
Sex in the last 90 days
Dichotomous indicator from self-report survey
Measured: 9 months after baseline
Sex without a condom in the last 90 days, by race/ethnicity
Dichotomous indicator from self-report survey
Measured: 9 months after baseline
Sex without a condom in the last 90 days
Dichotomous indicator from self-report survey
Measured: 21 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 posted14 Sep 2015 (estimated)
- Study startSep 2010
- Primary completionJun 2014
- Study completionAug 2015
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
- 12,253 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chapin Hall at the University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Chicago Public Schools
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02548871
- Sponsor's protocol ID
- TP1AH000066
- Status last verified
- Sep 2015
- First submitted
- 10 Sep 2015
- Last updated
- 14 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Seshadri R, Smithgall C, Goerge R, Ippolito J, Dasgupta D, Wiegand E, Guiltinan S, Wood M. (2015) Evaluation of the Teen Outreach Program: Findings from the Replication of an Evidence-Based Teen Pregnancy Prevention Program. Chicago, IL: Chapin Hall at the University of Chicago
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Teen Outreach Program in Chicago Public Schools: Replication of an Evidence-Based Teen Pregnancy Prevention Program
- ClinicalTrials.gov ID
- NCT02548871
- Acronym / sponsor ID
- TP1AH000066
- Conditions
- Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,253 participants (actual)
- Lead sponsor
- Chapin Hall at the University of ChicagoUniversity, hospital or other
- Collaborators
- Chicago Public Schools
- Study start
- Sep 2010
- Primary completion
- Jun 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 14 Sep 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.
The purpose of this study was to determine the impact of TOP® on sexual health behavior.
Detailed description
The cluster-randomized study was conducted in 9th grade classrooms in Chicago Public Schools (CPS) with equal number of schools randomized to intervention and comparison groups for two cohort years. Students were administered a scannable paper survey at three time points: baseline, post-program and 1-year post program. The primary impact analysis used an intent-to-treat approach. Implementation of TOP® was assessed by conducting classroom observations. TOP® was delivered in a variety of classroom settings over the school year by facilitators from CPS and partner organizations.
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 ProgramTeen Outreach Program |
| Comparison | No intervention | –Business as usual |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- First-time 9th grade student
- Passive parental consent and student assent
Key exclusion criteria (1 listed)
- Inability to complete survey in languages provided
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 positive youth development and service learning program for youth ages 12 to 17, and its Changing Scenes curriculum is separated into age appropriate levels. The program uses an approach that involves a caring adult, positive self-efficacy, future planning and goal setting and life management skills to to reduce risky sexual behavior and improve school outcomes. TOP® is designed to be delivered in weekly sessions over 9 months and includes community service learning. | Behavioural | Teen Outreach Program |
Primary outcome
Sex without a condom in the last 90 days
Time frame: 9 months after baseline
Dichotomous indicator from self-report survey
3 secondary outcomes
Sex in the last 90 days
Time frame: 9 months after baseline
Sex without a condom in the last 90 days, by race/ethnicity
Time frame: 9 months after baseline
Sex without a condom in the last 90 days
Time frame: 21 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 14 Sep 2015.
- BackgroundSeshadri R, Smithgall C, Goerge R, Ippolito J, Dasgupta D, Wiegand E, Guiltinan S, Wood M. (2015) Evaluation of the Teen Outreach Program: Findings from the Replication of an Evidence-Based Teen Pregnancy Prevention Program. Chicago, IL: Chapin Hall at the University of Chicago
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Teen Outreach Program in people with Sexual Behavior, run by Chapin Hall at the University of Chicago.
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 1 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 14 Sep 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?
Sex without a condom in the last 90 days (time frame: 9 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 NCT02548871, 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 14 Sep 2015.