Pregnancy in AdolescenceNCT01795885
Trial of the Effect of "16 and Pregnant" on Teen Girls' Attitudes About Pregnancy
A study testing 16 and Pregnant in people with Pregnancy in Adolescence and Teenage Pregnancy and Teen Parenting, run by University of Michigan.
Trial summary
The purpose of this study is to determine whether watching the MTV (Music Television) television show "16 and Pregnant" could affect teen girls' attitudes about teen pregnancy, teen parenting, and pregnancy prevention. Read more about this study
- Who is it for?
- Ages 15 to 18 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy in Adolescence, Teenage Pregnancy and Teen Parenting
- What is being tested?
- 16 and Pregnant
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to 13 Mar 2013
- 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 15 to 18 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- English speaking
- Female
- 15-18 years old
- Parental consent if under 18
Who cannot join
- Have watched more than one episode of "16 and Pregnant" in the past
- Lack of parental consent
About this study
Official title: Can "16 & Pregnant" Change Teens' Attitudes About Teen Pregnancy? A Randomized Controlled Trial
The purpose of this study is to determine whether watching the MTV (Music Television) television show "16 and Pregnant" could affect teen girls' attitudes about teen pregnancy, teen parenting, and pregnancy prevention. The investigators will recruit teen girls, ages 15-18, who will be randomized to the intervention group (who will be asked watch 4 episodes of the show over a 4 week period) or the control group (who will not be intentionally exposed to watching the show, and will not be told which show the intervention group is watching). The investigators will evaluate, through survey, their attitudes about teen pregnancy and teen parenting before and after the intervention period, and compare the two groups at the conclusion of the study.
The investigators' hypothesis is that the teens that are exposed to watching the show will have less favorable attitudes towards teen pregnancy and teen parenting than those teens who are not exposed to watching the show.
Read the detailed description
The objective of this study is to evaluate whether a television show, 16 and Pregnant, can be used as entertainment-education - specifically if it changes teens' attitudes about teen pregnancy and teen parenting. The primary outcome measure will be the change in attitudes about teen pregnancy and teen parenting after the intervention period.
Specific Aim: To determine the effect that watching the TV (television) show 16 and Pregnant has on teen girls' attitudes about teen pregnancy and teen parenting. Attitudes will be measured using the Thoughts on Teen Parenting Survey, which is a 44-item survey with 5-point Likert scale responses. Scores for the entire survey as well as sub-scale scores will be calculated both pre- and post-intervention.
Hypothesis: Teens who are exposed to themes of unintended teen pregnancy will have less favorable attitudes towards teen pregnancy and teen parenting when compared with similar teens not exposed to those themes.
In order to determine if the TV show 16 and Pregnant has any effect on teen girls' attitudes around teen pregnancy and parenting, the investigators plan to conduct a randomized controlled trial of an intervention consisting of watching the television program once a week for 4 weeks. Participants will be randomized to either the intervention arm, which will watch an approximately 45-minute commercial-free episode of the show 16 and Pregnant once a week for 4 weeks, or the control arm, which will not be intentionally exposed to the show. Each group will complete the same pre- and post-test survey to allow for comparisons between the groups.
All participants will be female teens between the ages of 15 and 18. Teens will be excluded if their parents do not permit them to participate, or if they do not assent to participate. They will also be excluded if they report having watched more than one episode (or more than 60 minutes) of 16 and Pregnant previously. The investigators plan to recruit approximately 215 teens to get a sample of 150 participants.
The survey instrument will be based on two previously developed surveys. The Thoughts on Teen Parenting Survey (TTPS) will be used to measure attitudes towards teen pregnancy and teen parenting. This is a previously validated 44-item survey designed to be used with adolescents ages 14-19 to evaluate teens' perceptions on teen pregnancy and teen parenting. A few additional questions, though not previously validated, will be used to evaluate teens' attitudes towards contraception, pregnancy options other than parenting (adoption or abortion), and sexual activity. These will be used to describe the population of teens in the study. The knowledge portion of the survey will be based on questions from the The National Survey of Reproductive and Contraceptive Knowledge (NSRCK), developed by The Guttmacher Institute and The National Campaign to Prevent Teen \& Unplanned Pregnancy. This survey was originally designed to measure contraceptive knowledge among 18-29 year olds. The reading level of many of the questions will be changed to accommodate a younger audience, but the content of the questions will remain the same. Again, this section of the survey will mainly be used to describe the group of teens in the study in terms of their level of contraceptive and reproductive health knowledge.
All surveys will be internet-based and will be administered by Knowledge Networks, a company that specializes in online survey research. Demographic information will be obtained via self-disclosure on the survey, as well as from the demographic information that is collected by Knowledge Networks when the participant agrees to join the KnowledgePanel®. Information about other sources of reproductive health knowledge will be assessed as well, including prior exposure to the show 16 and Pregnant.
Participants in the intervention group will complete a brief survey after watching each episode, as a measure to ensure that they actually watched the episode.
- Being tested
- 16 and Pregnant
- Keywords
- Pregnancy in Adolescence, Contraception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
16 and PregnantBehavioural
Participants in this arm will be asked to watch an approximately 45-minute commercial-free episode of the MTV television show "16 and Pregnant" once a week for 4 weeks. They will receive an email that contains a link to watch an episode of the show on the internet. The site where the videos are hosted is password protected and they are given the password in the same email. They can watch the video at any time, and can come back to it later if they need to stop watching it. The participants are asked to all watch the same episode each week. Four episodes were selected for the intervention from the first three seasons of the show.
| Study group | Role | What they receive |
|---|---|---|
| 16 and Pregnant | Experimental | Participants in this arm will be asked to watch an approximately 45-minute commercial-free episode of the show "16 and Pregnant" once a week for 4 weeks. Receives: Behavioral: 16 and Pregnant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes about teen pregnancy and teen parenting
The primary outcome will be the change in attitudes on teen pregnancy and teen parenting over the intervention period. This will be measured as the change in the composite score of the subjects' responses to the 44 questions from the Thoughts on Teen Parenting survey. This survey uses 5-point Likert scales for all responses. There is a minimum score of 44 and maximum score of 220, with lower scores indicating less favorable attitudes towards teen pregnancy. The change in the attitudinal score in the intervention group after the intervention will be compared to the change in the attitudinal score in the control group.
Measured: Baseline and at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2013 (estimated)
- Study startNov 2012
- Primary completion13 Mar 2013
- Study completion13 Mar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in AdolescenceStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Society of Family Planning
- Responsible party
- Principal investigator, Audrey Lance, University of Michigan
- Investigators
- Audrey A Lance, MD, Principal investigator, University of MichiganLisa H Harris, MD, Study chair, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01795885
- Sponsor's protocol ID
- SFPRF12-22
- Status last verified
- Jul 2017
- First submitted
- 8 Feb 2013
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can "16 & Pregnant" Change Teens' Attitudes About Teen Pregnancy? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01795885
- Acronym / sponsor ID
- SFPRF12-22
- Keywords
- Pregnancy in Adolescence, Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Society of Family Planning
- Study start
- Nov 2012
- Primary completion
- 13 Mar 2013 (actual)
- Study completion
- 13 Mar 2013 (actual)
- First posted
- 21 Feb 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.
The purpose of this study is to determine whether watching the MTV (Music Television) television show "16 and Pregnant" could affect teen girls' attitudes about teen pregnancy, teen parenting, and pregnancy prevention. The investigators will recruit teen girls, ages 15-18, who will be randomized to the intervention group (who will be asked watch 4 episodes of the show over a 4 week period) or the control group (who will not be intentionally exposed to watching the show, and will not be told which show the intervention group is watching). The investigators will evaluate, through survey, their attitudes about teen pregnancy and teen parenting before and after the intervention period, and compare the two groups at the conclusion of the study.
The investigators' hypothesis is that the teens that are exposed to watching the show will have less favorable attitudes towards teen pregnancy and teen parenting than those teens who are not exposed to watching the show.
Detailed description
The objective of this study is to evaluate whether a television show, 16 and Pregnant, can be used as entertainment-education - specifically if it changes teens' attitudes about teen pregnancy and teen parenting. The primary outcome measure will be the change in attitudes about teen pregnancy and teen parenting after the intervention period.
Specific Aim: To determine the effect that watching the TV (television) show 16 and Pregnant has on teen girls' attitudes about teen pregnancy and teen parenting. Attitudes will be measured using the Thoughts on Teen Parenting Survey, which is a 44-item survey with 5-point Likert scale responses. Scores for the entire survey as well as sub-scale scores will be calculated both pre- and post-intervention.
Hypothesis: Teens who are exposed to themes of unintended teen pregnancy will have less favorable attitudes towards teen pregnancy and teen parenting when compared with similar teens not exposed to those themes.
In order to determine if the TV show 16 and Pregnant has any effect on teen girls' attitudes around teen pregnancy and parenting, the investigators plan to conduct a randomized controlled trial of an intervention consisting of watching the television program once a week for 4 weeks. Participants will be randomized to either the intervention arm, which will watch an approximately 45-minute commercial-free episode of the show 16 and Pregnant once a week for 4 weeks, or the control arm, which will not be intentionally exposed to the show. Each group will complete the same pre- and post-test survey to allow for comparisons between the groups.
All participants will be female teens between the ages of 15 and 18. Teens will be excluded if their parents do not permit them to participate, or if they do not assent to participate. They will also be excluded if they report having watched more than one episode (or more than 60 minutes) of 16 and Pregnant previously. The investigators plan to recruit approximately 215 teens to get a sample of 150 participants.
The survey instrument will be based on two previously developed surveys. The Thoughts on Teen Parenting Survey (TTPS) will be used to measure attitudes towards teen pregnancy and teen parenting. This is a previously validated 44-item survey designed to be used with adolescents ages 14-19 to evaluate teens' perceptions on teen pregnancy and teen parenting. A few additional questions, though not previously validated, will be used to evaluate teens' attitudes towards contraception, pregnancy options other than parenting (adoption or abortion), and sexual activity. These will be used to describe the population of teens in the study. The knowledge portion of the survey will be based on questions from the The National Survey of Reproductive and Contraceptive Knowledge (NSRCK), developed by The Guttmacher Institute and The National Campaign to Prevent Teen \& Unplanned Pregnancy. This survey was originally designed to measure contraceptive knowledge among 18-29 year olds. The reading level of many of the questions will be changed to accommodate a younger audience, but the content of the questions will remain the same. Again, this section of the survey will mainly be used to describe the group of teens in the study in terms of their level of contraceptive and reproductive health knowledge.
All surveys will be internet-based and will be administered by Knowledge Networks, a company that specializes in online survey research. Demographic information will be obtained via self-disclosure on the survey, as well as from the demographic information that is collected by Knowledge Networks when the participant agrees to join the KnowledgePanel®. Information about other sources of reproductive health knowledge will be assessed as well, including prior exposure to the show 16 and Pregnant.
Participants in the intervention group will complete a brief survey after watching each episode, as a measure to ensure that they actually watched the episode.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 16 and Pregnant | Experimental | Behavioral: 16 and PregnantParticipants in this arm will be asked to watch an approximately 45-minute commercial-free episode of the show "16 and Pregnant" once a week for 4 weeks. |
Who may qualify
- Ages
- 15 to 18 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- English speaking
- Female
- 15-18 years old
- Parental consent if under 18
Key exclusion criteria (2 listed)
- Have watched more than one episode of "16 and Pregnant" in the past
- Lack of parental consent
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 |
|---|---|---|
| 16 and PregnantParticipants in this arm will be asked to watch an approximately 45-minute commercial-free episode of the MTV television show "16 and Pregnant" once a week for 4 weeks. They will receive an email that contains a link to watch an episode of the show on the internet. The site where the videos are hosted is password protected and they are given the password in the same email. They can watch the video at any time, and can come back to it later if they need to stop watching it. The participants are asked to all watch the same episode each week. Four episodes were selected for the intervention from the first three seasons of the show. | Behavioural | 16 and Pregnant |
Primary outcome
Attitudes about teen pregnancy and teen parenting
Time frame: Baseline and at 6 weeks
The primary outcome will be the change in attitudes on teen pregnancy and teen parenting over the intervention period. This will be measured as the change in the composite score of the subjects' responses to the 44 questions from the Thoughts on Teen Parenting survey. This survey uses 5-point Likert scales for all responses. There is a minimum score of 44 and maximum score of 220, with lower scores indicating less favorable attitudes towards teen pregnancy. The change in the attitudinal score in the intervention group after the intervention will be compared to the change in the attitudinal score in the control group.
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 Jul 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.
Audrey A Lance, MD principal investigator
University of Michigan
Lisa H Harris, MD study chair
University of Michigan
Questions about this trial
What is this clinical trial studying?
A study testing 16 and Pregnant in people with Pregnancy in Adolescence and Teenage Pregnancy and Teen Parenting, run by University of Michigan.
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 Jul 2017. 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?
Attitudes about teen pregnancy and teen parenting (time frame: Baseline and at 6 weeks). 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 Jul 2017.