Pregnancy PreventionTOP4MENCT01535651
Using Social Media to Enhance the Impact of the Teen Outreach Program
A study testing Teen Outreach Program with Media Enhancement (TOP4ME) in people with Pregnancy Prevention, run by Colorado School of Public Health at 1 site in United States.
Trial summary
The investigators are exploring the use of short message service (text) messaging by cell phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy prevention program. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Prevention
- What is being tested?
- Teen Outreach Program with Media Enhancement (TOP4ME)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 852 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- boys and girls club member in metro Denver, age 14-18
Who cannot join
- non-english speaking
Trial locations and contacts
1 site in 1 country.
United States1 site
Boys and Girls Clubs of Metro Denver
Denver, Colorado, 80204
About this study
The investigators are exploring the use of short message service (text) messaging by cell phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy prevention program.
- Conditions
- Pregnancy Prevention
- Being tested
- Teen Outreach Program with Media Enhancement (TOP4ME)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teen Outreach Program with Media Enhancement (TOP4ME)Behavioural
Also called Youth All Engaged! (YAE!)
Persons participating in TOP will receive text messages weekly in addition to TOP
| Study group | Role | What they receive |
|---|---|---|
| TOP Program plus Text messaging | Experimental | Boys and Girls Club members who participate in TOP over 9 months will receive regular text messages in addition to TOP Receives: Behavioral: Teen Outreach Program with Media Enhancement (TOP4ME) |
| TOP Program alone | No intervention | Boys and Girls Club participants will participate in TOP for 9 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy
Measured: 21 months
Secondary outcomes (1)
school drop out
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 posted20 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionMay 2015
- Study completionMay 2016
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 Pregnancy PreventionStudies 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
- 852 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colorado School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- Denver Health and Hospital Authority
- Responsible party
- Principal investigator, Sheana Bull, Colorado School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01535651
- Sponsor's protocol ID
- OAH Denver Health
- Acronym
- TOP4ME
- Status last verified
- May 2018
- First submitted
- 15 Feb 2012
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Devine S, Bull S, Dreisbach S, Shlay J. Enhancing a Teen Pregnancy Prevention Program with text messaging: engaging minority youth to develop TOP (R) Plus Text. J Adolesc Health. 2014 Mar;54(3 Suppl):S78-83. doi: 10.1016/j.jadohealth.2013.12.005.
PubMed 24560081
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Social Media to Enhance the Impact of the Teen Outreach Program
- ClinicalTrials.gov ID
- NCT01535651
- Acronym / sponsor ID
- TOP4ME / OAH Denver Health
- Conditions
- Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 852 participants (actual)
- Lead sponsor
- Colorado School of Public HealthUniversity, hospital or other
- Collaborators
- Denver Health and Hospital Authority
- Study start
- Sep 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 20 Feb 2012 (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 investigators are exploring the use of short message service (text) messaging by cell phones to enhance the effects of the Teen Outreach Program, an effective teen pregnancy prevention program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TOP Program plus Text messaging | Experimental | Behavioral: Teen Outreach Program with Media Enhancement (TOP4ME)Boys and Girls Club members who participate in TOP over 9 months will receive regular text messages in addition to TOP |
| TOP Program alone | No intervention | –Boys and Girls Club participants will participate in TOP for 9 months |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- boys and girls club member in metro Denver, age 14-18
Key exclusion criteria (1 listed)
- non-english speaking
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 Program with Media Enhancement (TOP4ME)Also: Youth All Engaged! (YAE!)Persons participating in TOP will receive text messages weekly in addition to TOP | Behavioural | TOP Program plus Text messaging |
Primary outcome
pregnancy
Time frame: 21 months
1 secondary outcome
school drop out
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 17 May 2018.
- Background: PubMed 24560081Devine S, Bull S, Dreisbach S, Shlay J. Enhancing a Teen Pregnancy Prevention Program with text messaging: engaging minority youth to develop TOP (R) Plus Text. J Adolesc Health. 2014 Mar;54(3 Suppl):S78-83. doi: 10.1016/j.jadohealth.2013.12.005.
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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.
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 with Media Enhancement (TOP4ME) in people with Pregnancy Prevention, run by Colorado School of Public Health 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 1 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 17 May 2018. 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?
pregnancy (time frame: 21 months). 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 NCT01535651, 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 17 May 2018.