Sexual BehaviorNCT02059486
Impact Evaluation of the Teen Choice Program
A study testing Teen Choice in people with Sexual Behavior, run by Mathematica Policy Research, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to evaluate the impact of the Teen Choice program on reducing the rates of unprotected sex of high risk youth in New York. 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
- What is being tested?
- Teen Choice
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 465 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2014to Jun 2018
- 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
- Age 12-19
- Attending one of the participating schools
Who cannot join
- Juvenile Justice Youth
- School clinician determined trauma histories
- School clinician determined developmental issues
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
R.O.A.D.S.
Brooklyn, New York, 11233
Clark Academy
Dobbs Ferry, New York, 10522
Robert H Goddard High School
New York, New York, 11417
Bronx Community High School
The Bronx, New York, 10473
Biondi School
Yonkers, New York, 10705
About this study
The purpose of this study is to evaluate the impact of the Teen Choice program on reducing the rates of unprotected sex of high risk youth in New York.
Read the detailed description
This study uses a randomized controlled design to compare the impacts of the Teen Choice Program to the "business-as-usual" school curriculum. The Teen Choice curriculum is designed for adolescents aged 12 to 19 and will be delivered in different formats that range in length from 6 to 12 weeks. Teen Choice will be offered during the regular school day to middle and high school aged youth. This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.
- Conditions
- Sexual Behavior
- Being tested
- Teen Choice
- 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 ChoiceBehavioural
The curriculum provides sexual education on topics such as anatomy, puberty, sexually transmitted infections, and contraceptive methods (including abstinence). It also covers topics such as gender and sex roles, sexual orientation, decision making and conflict resolution, adult-teen relationships, rape and sexual assault, and coping with stress.
| Study group | Role | What they receive |
|---|---|---|
| Teen Choice | Experimental | The curriculum provides comprehensive sexual education on topics such as anatomy, puberty, sexually transmitted infections, and contraceptive methods (including abstinence). It also covers topics such as gender and sex roles, sexual orientation, decision making and conflict resolution, adult-teen relationships, rape and sexual assault, and coping with stress. The curriculum can be delivered in different formats that range in length from 6 to 12 weeks. Receives: Behavioral: Teen Choice |
| Control | No intervention | Business as usual school health curriuclum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unprotected sex in the three months prior to the survey
Measured: 6-months post random assignment
Secondary outcomes (1)
Sexual Initiation
Measured: 6-months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startJan 2014
- Primary completionJun 2018 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 465 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathematica Policy Research, Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Wood, PhD, Study director, Mathematica Policy Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059486
- Sponsor's protocol ID
- PRP699104
- Status last verified
- Apr 2017
- First submitted
- 30 Jan 2014
- Last updated
- 17 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of the Teen Choice Program
- ClinicalTrials.gov ID
- NCT02059486
- Acronym / sponsor ID
- PRP699104
- Conditions
- Sexual Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 465 participants (actual)
- Lead sponsor
- Mathematica Policy Research, Inc.University, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 11 Feb 2014 (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 is to evaluate the impact of the Teen Choice program on reducing the rates of unprotected sex of high risk youth in New York.
Detailed description
This study uses a randomized controlled design to compare the impacts of the Teen Choice Program to the "business-as-usual" school curriculum. The Teen Choice curriculum is designed for adolescents aged 12 to 19 and will be delivered in different formats that range in length from 6 to 12 weeks. Teen Choice will be offered during the regular school day to middle and high school aged youth. This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teen Choice | Experimental | Behavioral: Teen ChoiceThe curriculum provides comprehensive sexual education on topics such as anatomy, puberty, sexually transmitted infections, and contraceptive methods (including abstinence). It also covers topics such as gender and sex roles, sexual orientation, decision making and conflict resolution, adult-teen relationships, rape and sexual assault, and coping with stress. The curriculum can be delivered in different formats that range in length from 6 to 12 weeks. |
| Control | No intervention | –Business as usual school health curriuclum |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 12-19
- Attending one of the participating schools
Key exclusion criteria (3 listed)
- Juvenile Justice Youth
- School clinician determined trauma histories
- School clinician determined developmental issues
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 ChoiceThe curriculum provides sexual education on topics such as anatomy, puberty, sexually transmitted infections, and contraceptive methods (including abstinence). It also covers topics such as gender and sex roles, sexual orientation, decision making and conflict resolution, adult-teen relationships, rape and sexual assault, and coping with stress. | Behavioural | Teen Choice |
Primary outcome
Unprotected sex in the three months prior to the survey
Time frame: 6-months post random assignment
1 secondary outcome
Sexual Initiation
Time frame: 6-months post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2017.
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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.
Robert Wood, PhD study director
Mathematica Policy Research
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teen Choice in people with Sexual Behavior, run by Mathematica Policy Research, Inc. at 5 sites 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 3 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: status not confirmed, as of the sponsor's last update on 17 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
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?
Unprotected sex in the three months prior to the survey (time frame: 6-months post random assignment). 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 17 Apr 2017.