Adolescent ProblemsNCT02723292
City of Rochester Teen Outreach Program (TOP™) Evaluation
A study testing TOP in people with Adolescent Problems and Sex Behavior, run by University of Rochester.
Trial summary
As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is partnering with the City of Rochester Department of Recreation and Youth Services to evaluate the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth registered at 11 selected Recreation Centers… Read more about this study
- Who is it for?
- Ages 11 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescent Problems, Sex Behavior, Academic Underachievement Disorder of Childhood or Adolescence
- What is being tested?
- TOP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,188 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Apr 2016
- 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 11 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- must be registered at a participating RC
- age 11 through 14 years
- participants must assent and parent(s) or legal guardian(s) provide permission to participate
- basic understanding of the English language
Who cannot join
- age at enrollment of less than 11 or greater than 14 years
- for facilitators, age less than 21 is an exclusion criterion
About this study
As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is partnering with the City of Rochester Department of Recreation and Youth Services to evaluate the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth registered at 11 selected Recreation Centers (RCs). A youth development program with demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will also measure program fidelity obtained in RCs.
- Conditions
- Adolescent Problems, Sex Behavior, Academic Underachievement Disorder of Childhood or Adolescence
- Being tested
- TOP, Control intervention
- Medical subject headings
- Sexual Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TOPBehavioural
Control interventionBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Experimental group services | Experimental | This study will replicate the evidence-based TOP™ in after-school sessions held during RC hours. The primary components of TOP™ include: Comprehensive age-appropriate sexuality education; 90-minute sessions, once a week after-school, during the school year for nine months, using the Changing Scenes© curriculum, and at least twenty hours of youth-led service learning, which involves youth in planning, implementing and reflecting on, community service and leadership. Receives: Behavioral: TOP |
| Control group services | Active comparator | Youth in the control arm will receive a work readiness training curriculum focused on competencies to secure employment. This will include such topics as building customer service skills, clear and direct communication, and creating a work portfolio. Receives: Behavioral: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who become pregnant
Measured: 21 months
Number of youth who report ever having had sexual intercourse
For youth who were sexually naive at baseline, the outcome is the number of youth who report ever having had sexual intercourse at the 21 month assessment point.
Measured: 21 months
Amount of sexual intercourse in preceding 3 months without an effective means of birth control
The number of times a youth reports having had sexual intercourse without using an effective means of birth control measured at the 21 month assessment point.
Measured: 21 months
Secondary outcomes (1)
Number of failing grades on report card
This is a self-report measure of the number of courses failed on the last report card received, measured at the 21 month assessment point.
Measured: 21 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2016 (estimated)
- Study startSep 2011
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent ProblemsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- None (open label)
- Enrolment
- 1,188 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- State University of New York at Binghamton, Decker School of Nursing, City of Rochester Department of Recreation and Youth Services
- Responsible party
- Principal investigator, Hugh Crean, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02723292
- Sponsor's protocol ID
- 36508
- Status last verified
- Feb 2018
- First submitted
- 4 Feb 2016
- Last updated
- 12 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- City of Rochester Teen Outreach Program (TOP™) Evaluation
- ClinicalTrials.gov ID
- NCT02723292
- Acronym / sponsor ID
- 36508
- Conditions
- Adolescent Problems, Sex Behavior, Academic Underachievement Disorder of Childhood or Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,188 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- State University of New York at Binghamton, Decker School of Nursing, City of Rochester Department of Recreation and Youth Services
- Study start
- Sep 2011
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 30 Mar 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.
As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is partnering with the City of Rochester Department of Recreation and Youth Services to evaluate the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth registered at 11 selected Recreation Centers (RCs). A youth development program with demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will also measure program fidelity obtained in RCs.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group services | Experimental | Behavioral: TOPThis study will replicate the evidence-based TOP™ in after-school sessions held during RC hours. The primary components of TOP™ include: Comprehensive age-appropriate sexuality education; 90-minute sessions, once a week after-school, during the school year for nine months, using the Changing Scenes© curriculum, and at least twenty hours of youth-led service learning, which involves youth in planning, implementing and reflecting on, community service and leadership. |
| Control group services | Active comparator | Behavioral: Control interventionYouth in the control arm will receive a work readiness training curriculum focused on competencies to secure employment. This will include such topics as building customer service skills, clear and direct communication, and creating a work portfolio. |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- must be registered at a participating RC
- age 11 through 14 years
- participants must assent and parent(s) or legal guardian(s) provide permission to participate
- basic understanding of the English language
Key exclusion criteria (2 listed)
- age at enrollment of less than 11 or greater than 14 years
- for facilitators, age less than 21 is an exclusion criterion
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 |
|---|---|---|
| TOP | Behavioural | Experimental group services |
| Control intervention | Behavioural | Control group services |
Primary outcome
Number of participants who become pregnant
Time frame: 21 months
Number of youth who report ever having had sexual intercourse
Time frame: 21 months
For youth who were sexually naive at baseline, the outcome is the number of youth who report ever having had sexual intercourse at the 21 month assessment point.
Amount of sexual intercourse in preceding 3 months without an effective means of birth control
Time frame: 21 months
The number of times a youth reports having had sexual intercourse without using an effective means of birth control measured at the 21 month assessment point.
1 secondary outcome
Number of failing grades on report card
Time frame: 21 months
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 12 Feb 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Adolescent Problems
RecruitingObservational study
Environmental Mixtures, Cognitive Control and Reward Processes, and Risk for Psychiatric Problems in Adolescence
Psychiatric Problem
Recruiting
A Randomized Controlled Trial Testing the Effect of the Youth Mindful Awareness Program on Negative Affect (YMAP2).
Prevention, Control
Recruiting
HOBSCOTCH-YOUTH and Young Adults
Epilepsy, Cognitive Dysfunction, Cognitive Disorder
Active, not recruiting
Improving Student Mental Health Through a Universal Trauma-Informed Intervention
Anxiety Symptoms, Post-traumatic Stress Symptoms
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
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 TOP in people with Adolescent Problems and Sex Behavior, run by University of Rochester.
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 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 12 Feb 2018. 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 who become pregnant (time frame: 21 months). The study lists 3 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 12 Feb 2018.