F01.145.802.845PreparedNCT01880450
Project Prepared: Risks, Roles and Relationships
A study testing Project Prepared and TEEN in people with F01.145.802.845 and F01.145.802.987, run by Albert Einstein College of Medicine at 1 site in United States.
Trial summary
Project Prepared is a theoretically based, comprehensive, intensive group intervention that is designed to prepare early adolescents for middle adolescence and its challenges. It emphasizes skills in avoiding risky sexual situations, and provides medically accurate information about sexual development, sexually… Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- F01.145.802.845, F01.145.802.987
- What is being tested?
- Project Prepared and TEEN
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 397 participants
- Where
- 1 siteUnited States
- Study dates
- May 2009to Dec 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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12-14 yrs old
- lives in the Bronx, NY at Baseline
- Has been seen at some point in one of the Montefiore Medical Center community health clinics.
Who cannot join
- Inability to independently complete the questionnaire/training due to sensory, cognitive or motor disabilities.
- Reading ability NOT at 5th grade on the reading subtest of the Wide-range Achievement Test.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein College of Medicine
The Bronx, New York, 10461
About this study
Official title: Longitudinal Intervention Study to Prepare Early Adolescents for Middle Adolescence, Specifically Focusing on Improving Sexual Health Outcomes
Project Prepared is a theoretically based, comprehensive, intensive group intervention that is designed to prepare early adolescents for middle adolescence and its challenges. It emphasizes skills in avoiding risky sexual situations, and provides medically accurate information about sexual development, sexually transmitted infections and pregnancy. Effectiveness is measured by using a randomized control trial design and tracking differences in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge, sexual self-efficacy; intention to use a condom); relationship factors (immature romantic beliefs, relationship self-efficacy), gender norms (macho man, powerless female), and resilience.
- Conditions
- F01.145.802.845, F01.145.802.987
- Being tested
- Project Prepared, TEEN
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Project PreparedBehavioural
Behavioral intervention to reduce sexual risk and promote healthy relationships
TEENBehavioural
Control condition the promote communication, decision-making skills etc.
| Study group | Role | What they receive |
|---|---|---|
| Project Prepared | Experimental | Not described Receives: Behavioral: Project Prepared |
| TEEN-Teen Education & Employment Network | Active comparator | Not described Receives: Behavioral: TEEN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intentions to engage in safer sex behavior at 6 months
measuring change from baseline to 6 months (as compared to control group)
Measured: 6 months post baseline
Change in Intentions to engage in safer sex behavior at 1 year
measuring change from baseline to 1 year (as compared to control group)
Measured: 1 year post baseline
Secondary outcomes (2)
Change in Cognitive Factors at 6 months
measuring change in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 6 months (compared to control group)
Measured: 6 months post baseline
Change in Cognitive Factors at 1 year
measuring changes in HIV/STI knowledge, condom outcome and efficacy expectancies, sexual self-efficacy from baseline to 1 year (as compared to control group)
Measured: 1 year post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2013 (estimated)
- Study startMay 2009
- Primary completionMar 2014
- Study completionDec 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 F01.145.802.845Studies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 397 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Principal investigator, Laurie Bauman, Albert Einstein College of Medicine
- Investigators
- Laurie J Bauman, PhD, Principal investigator, Albert Einstein College of Medicine, Pediatrics Division
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01880450
- Sponsor's protocol ID
- 2008-551
- Other IDs
- 5R01HD062079
- Acronym
- Prepared
- Status last verified
- Jan 2015
- First submitted
- 12 Jul 2011
- Last updated
- 14 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bauman LJ, Watnick D, Silver EJ, Rivera A, Sclafane JH, Rodgers CRR, Leu CS. Reducing HIV/STI Risk Among Adolescents Aged 12 to 14 Years: a Randomized Controlled Trial of Project Prepared. Prev Sci. 2021 Nov;22(8):1023-1035. doi: 10.1007/s11121-021-01203-0. Epub 2021 Feb 19.
PubMed 33606173
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Intervention Study to Prepare Early Adolescents for Middle Adolescence, Specifically Focusing on Improving Sexual Health Outcomes
- ClinicalTrials.gov ID
- NCT01880450
- Acronym / sponsor ID
- Prepared / 2008-551
- Conditions
- F01.145.802.845, F01.145.802.987
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 397 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- May 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 19 Jun 2013 (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.
Project Prepared is a theoretically based, comprehensive, intensive group intervention that is designed to prepare early adolescents for middle adolescence and its challenges. It emphasizes skills in avoiding risky sexual situations, and provides medically accurate information about sexual development, sexually transmitted infections and pregnancy. Effectiveness is measured by using a randomized control trial design and tracking differences in cognitive factors (HIV/STI (Sexually Transmitted Infections) knowledge, sexual self-efficacy; intention to use a condom); relationship factors (immature romantic beliefs, relationship self-efficacy), gender norms (macho man, powerless female), and resilience.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Project Prepared | Experimental | Behavioral: Project Prepared |
| TEEN-Teen Education & Employment Network | Active comparator | Behavioral: TEEN |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 12-14 yrs old
- lives in the Bronx, NY at Baseline
- Has been seen at some point in one of the Montefiore Medical Center community health clinics.
Key exclusion criteria (2 listed)
- Inability to independently complete the questionnaire/training due to sensory, cognitive or motor disabilities.
- Reading ability NOT at 5th grade on the reading subtest of the Wide-range Achievement Test.
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 |
|---|---|---|
| Project PreparedBehavioral intervention to reduce sexual risk and promote healthy relationships | Behavioural | Project Prepared |
| TEENControl condition the promote communication, decision-making skills etc. | Behavioural | TEEN-Teen Education & Employment Network |
Primary outcome
Change in Intentions to engage in safer sex behavior at 6 months
Time frame: 6 months post baseline
measuring change from baseline to 6 months (as compared to control group)
Change in Intentions to engage in safer sex behavior at 1 year
Time frame: 1 year post baseline
measuring change from baseline to 1 year (as compared to control group)
2 secondary outcomes
Change in Cognitive Factors at 6 months
Time frame: 6 months post baseline
Change in Cognitive Factors at 1 year
Time frame: 1 year post 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 Jan 2015.
- Derived from this study: PubMed 33606173Bauman LJ, Watnick D, Silver EJ, Rivera A, Sclafane JH, Rodgers CRR, Leu CS. Reducing HIV/STI Risk Among Adolescents Aged 12 to 14 Years: a Randomized Controlled Trial of Project Prepared. Prev Sci. 2021 Nov;22(8):1023-1035. doi: 10.1007/s11121-021-01203-0. Epub 2021 Feb 19.
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.
Laurie J Bauman, PhD principal investigator
Albert Einstein College of Medicine, Pediatrics Division
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Project Prepared and TEEN in people with F01.145.802.845 and F01.145.802.987, run by Albert Einstein College of Medicine 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 3 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 14 Jan 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?
Change in Intentions to engage in safer sex behavior at 6 months (time frame: 6 months post baseline). 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 NCT01880450, 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 Jan 2015.