Adolescent PregnancyPPP_2NCT02333019
A Parent Child Program to Prevent Adolescent Pregnancy
A study testing Let's Talk About Sex and Websites; preventing teen pregnancy in people with Adolescent Pregnancy and Sexually Transmitted Diseases, run by Oregon Center for Applied Science, Inc. at 1 site in United States.
Trial summary
While the U.S. teen birth rate is currently at its lowest level, it remains high in relation to other industrialized countries and continues to be a public health concern due to health risks for teen mothers and their babies, and associated social and economic costs. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Adolescent Pregnancy, Sexually Transmitted Diseases, Parental
- What is being tested?
- Let's Talk About Sex and Websites; preventing teen pregnancy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 395 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2013to Apr 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parent or guardian with a child 10-14 years of age
- Parent / guardian must be over the age of 18
- Child must live with the parent participating in the study at least 50% of the time
Who cannot join
- Parents or guardians with a child not fitting within the specified age range
- Parents or guardians whose child does not live with him/her at least 50% of the time
- Parents or guardians younger than 18 years old; due to online nature of the evaluation, we were unable to verify parental consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Center for Applied Science
Eugene, Oregon, 97401
About this study
While the U.S. teen birth rate is currently at its lowest level, it remains high in relation to other industrialized countries and continues to be a public health concern due to health risks for teen mothers and their babies, and associated social and economic costs. Parental monitoring, supervision, and open communication about sexual issues have been found to be protective factors for adolescent sexual activity and pregnancy. Our theoretically based Internet program for parents of pre-adolescent children aged 10-14, Let's Talk about Sex, is designed to build parental communication, knowledge, and attitudes to discuss sensitive topics with their child, including sexuality, pregnancy prevention, and preventing sexually transmitted illnesses (STIs). This age group of children was selected because parental communication about pregnancy and STI prevention will be most effective if initiated prior to, rather than after, the age when children commonly become sexually active. The "Let's Talk about Sex" program is grounded in behavior change theory and incorporates the use of video for behavioral modeling and emotional support.
Read the detailed description
"Let's Talk about Sex" was designed to help parents talk to their 10- to 14-year old children about sex and relationships. The goal of the program for the parent was to build skills to communicate effectively with their children about parental values and about issues relating to sexuality, specifically by: a) increasing communication with their child about sexuality; b) increasing behavioral intentions to communicate; c) decreasing perceived barriers to communicating about sexuality; (d) increasing perceived sense of importance/motivation for communicating about sexuality; and e) increasing knowledge about risks of adolescent pregnancy and sexually transmitting infections (STIs). The goal of the intervention for the child was to increase child-parent communication about sexuality issues.
Program content was derived from the research literature; focus group findings, and input from professional consultants, experts in the field with extensive experience working with communication about sexuality. Modifications to content and program format were made based on iterative usability testing.
The parents' program was structured around five sessions, which guided the user through a topic-oriented experience of the content. The program used text, video narration, and video testimonials to present the intervention material. Emails were sent to users weekly for 8 weeks, with a link to a recommended session. Users could also browse the content freely as desired. Topics for parents included (1) Influencing your child's decisions about sex; (2) Understanding your own sexual values and beliefs; (3) Helping your child prepare for adolescence; (4) Preventing pregnancy and disease; and (5) Healthy relationships. Parents who responded to a values and beliefs quiz within the "Understanding your own sexual values and beliefs" section were presented with recommended articles tailored to their responses.
The child's intervention was structured as one session with four brief topics: (1) a whiteboard animation titled "How to talk to your parents about sex and not die of embarrassment"; (2) an article about bodily changes related to puberty; (3) a "What's most important to me" quiz; and (4) an article about healthy relationships.
- Being tested
- Let's Talk About Sex, Websites; preventing teen pregnancy
- Keywords
- risk
- Medical subject headings
- Sexually Transmitted Diseases, Communication, Sexuality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Let's Talk About SexBehavioural
Multimedia web site to build parental skills in communicating with their pre-adolescnet child sex and relationships, pregnancy prevention, and risk of sexually transmitted infections.
Websites; preventing teen pregnancyBehavioural
Two general web sites with information about preventing teen pregnancy
| Study group | Role | What they receive |
|---|---|---|
| Let's Talk About Sex | Experimental | Participants assigned to the treatment condition viewed a multimedia web site designed to help parents of pre-adolescent children, aged 10 to 14 years old, build skills to communicate effectively about parental values and issues relating to sexuality, sex and relationships, and preventing pregnancy and sexually transmitted infections. Receives: Behavioral: Let's Talk About Sex |
| Websites; preventing teen pregnancy | Active comparator | Participants assigned to the control condition were emailed urls for websites with information similar to the Let's Talk about Sex program. Parents were directed to the parents section of the National Campaign to Prevent Teen and Unplanned Pregnancy and children were directed to Nemours' KidsHealth website. Receives: Behavioral: Websites; preventing teen pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral activation as measured by the Parent-Teen Sexual Risk Communication Scale
Behavioral activation around discussions with their child was assessed with 9 items from the Parent-Teen Sexual Risk Communication Scale (Hutchinson, 2007). The items measure the type and quantity of information relayed in the parent-child conversation and were adapted to more precisely measure the content of the program (e.g., In general how much information have you shared with your daughter or son about human sexuality?). Response options were on a 5-point scale (1=none; 5=everything).
Measured: 8-week follow-up
Secondary outcomes (5)
Behavioral intentions of parent to communicate with their child about sexuality and related topics
Seven items measuring parental intentions to talk with their child about sexuality, relationships, dating, preventing pregnancy and STSIs were derived from the content of the program (e.g., How likely is it that you will talk to your child about your values and beliefs about sex and relationships?). Response options were on a 5-point scale (1=extremely unlikely; 5=extremely likely).
Measured: 4-week posttest and 8-week follow-up
Parents' perceived barriers in communicating with their children regarding pregnancy prevention and contraception
Attitudes and beliefs around barriers were assessed with a 16- item scale developed by Jaccard et al. (2000) to measure beliefs, attitudes, and perceived barriers to parents communicating with children regarding pregnancy prevention and contraception. Items were adapted to more precisely measure the content of the program (e.g., My child is just too busy to talk to me about sex and birth control). Response options were on a 5-point scale (1=strongly disagree; 5=strongly agree).
Measured: 4-week posttest and 8-week follow-up
Parents' perception of importance of communicating with their teen about sexuality and related topics
Attitudes and beliefs around importance/motivation were assessed with a 6-item scale developed from concepts taught in the program pertaining to parents' sense of importance or motivation for communicating with their teen about sexuality (e.g., It is extremely important to me to talk to my child about his/her sexual feelings.). Response options were on a 5-point scale (1=strongly disagree; 5=strongly agree).
Measured: 4-week posttest and 8-week follow-up
Parents' knowledge of parent-teen communication about sexuality, birth control, and preventing sexually transmitted infections.
A 10-item true-false scale and 5 multiple-choice items were developed from program content to assess parents' knowledge of parent-teen communication about sexuality, birth control, and preventing STIs. The total number of correct items was divided by the total number of items representing the proportion of knowledge items correctly endorsed.
Measured: 4-week posttest and 8-week follow-up
Users' perception of program usability
At posttest (T2), treatment participants completed an 11-item questionnaire from the Action-WAMMI (Chambers et al., 2002) assessing ease of use and experience in the program. Users were asked to what degree they agreed or disagreed with program use and satisfaction statements on a 5-point scale (1=strongly disagree; 5=strongly agree).
Measured: 4-week posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2015 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent PregnancyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 395 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Center for Applied Science, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Susan Schroeder, Oregon Center for Applied Science, Inc.
- Investigators
- Susan Schroeder, MPH, MCHES, Principal investigator, Oregon Center for Applied Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02333019
- Sponsor's protocol ID
- SBIR79RR-IIRR
- Other IDs
- R44HD048057
- Acronym
- PPP_2
- Status last verified
- Nov 2015
- First submitted
- 2 Jan 2015
- Last updated
- 10 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Parent Child Program to Prevent Adolescent Pregnancy
- ClinicalTrials.gov ID
- NCT02333019
- Acronym / sponsor ID
- PPP_2 / SBIR79RR-IIRR
- Keywords
- risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 395 participants (actual)
- Lead sponsor
- Oregon Center for Applied Science, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Jan 2015 (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.
While the U.S. teen birth rate is currently at its lowest level, it remains high in relation to other industrialized countries and continues to be a public health concern due to health risks for teen mothers and their babies, and associated social and economic costs. Parental monitoring, supervision, and open communication about sexual issues have been found to be protective factors for adolescent sexual activity and pregnancy. Our theoretically based Internet program for parents of pre-adolescent children aged 10-14, Let's Talk about Sex, is designed to build parental communication, knowledge, and attitudes to discuss sensitive topics with their child, including sexuality, pregnancy prevention, and preventing sexually transmitted illnesses (STIs). This age group of children was selected because parental communication about pregnancy and STI prevention will be most effective if initiated prior to, rather than after, the age when children commonly become sexually active. The "Let's Talk about Sex" program is grounded in behavior change theory and incorporates the use of video for behavioral modeling and emotional support.
Detailed description
"Let's Talk about Sex" was designed to help parents talk to their 10- to 14-year old children about sex and relationships. The goal of the program for the parent was to build skills to communicate effectively with their children about parental values and about issues relating to sexuality, specifically by: a) increasing communication with their child about sexuality; b) increasing behavioral intentions to communicate; c) decreasing perceived barriers to communicating about sexuality; (d) increasing perceived sense of importance/motivation for communicating about sexuality; and e) increasing knowledge about risks of adolescent pregnancy and sexually transmitting infections (STIs). The goal of the intervention for the child was to increase child-parent communication about sexuality issues.
Program content was derived from the research literature; focus group findings, and input from professional consultants, experts in the field with extensive experience working with communication about sexuality. Modifications to content and program format were made based on iterative usability testing.
The parents' program was structured around five sessions, which guided the user through a topic-oriented experience of the content. The program used text, video narration, and video testimonials to present the intervention material. Emails were sent to users weekly for 8 weeks, with a link to a recommended session. Users could also browse the content freely as desired. Topics for parents included (1) Influencing your child's decisions about sex; (2) Understanding your own sexual values and beliefs; (3) Helping your child prepare for adolescence; (4) Preventing pregnancy and disease; and (5) Healthy relationships. Parents who responded to a values and beliefs quiz within the "Understanding your own sexual values and beliefs" section were presented with recommended articles tailored to their responses.
The child's intervention was structured as one session with four brief topics: (1) a whiteboard animation titled "How to talk to your parents about sex and not die of embarrassment"; (2) an article about bodily changes related to puberty; (3) a "What's most important to me" quiz; and (4) an article about healthy relationships.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Let's Talk About Sex | Experimental | Behavioral: Let's Talk About SexParticipants assigned to the treatment condition viewed a multimedia web site designed to help parents of pre-adolescent children, aged 10 to 14 years old, build skills to communicate effectively about parental values and issues relating to sexuality, sex and relationships, and preventing pregnancy and sexually transmitted infections. |
| Websites; preventing teen pregnancy | Active comparator | Behavioral: Websites; preventing teen pregnancyParticipants assigned to the control condition were emailed urls for websites with information similar to the Let's Talk about Sex program. Parents were directed to the parents section of the National Campaign to Prevent Teen and Unplanned Pregnancy and children were directed to Nemours' KidsHealth website. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Parent or guardian with a child 10-14 years of age
- Parent / guardian must be over the age of 18
- Child must live with the parent participating in the study at least 50% of the time
Key exclusion criteria (3 listed)
- Parents or guardians with a child not fitting within the specified age range
- Parents or guardians whose child does not live with him/her at least 50% of the time
- Parents or guardians younger than 18 years old; due to online nature of the evaluation, we were unable to verify 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 |
|---|---|---|
| Let's Talk About SexMultimedia web site to build parental skills in communicating with their pre-adolescnet child sex and relationships, pregnancy prevention, and risk of sexually transmitted infections. | Behavioural | Let's Talk About Sex |
| Websites; preventing teen pregnancyTwo general web sites with information about preventing teen pregnancy | Behavioural | Websites; preventing teen pregnancy |
Primary outcome
Behavioral activation as measured by the Parent-Teen Sexual Risk Communication Scale
Time frame: 8-week follow-up
Behavioral activation around discussions with their child was assessed with 9 items from the Parent-Teen Sexual Risk Communication Scale (Hutchinson, 2007). The items measure the type and quantity of information relayed in the parent-child conversation and were adapted to more precisely measure the content of the program (e.g., In general how much information have you shared with your daughter or son about human sexuality?). Response options were on a 5-point scale (1=none; 5=everything).
5 secondary outcomes
Behavioral intentions of parent to communicate with their child about sexuality and related topics
Time frame: 4-week posttest and 8-week follow-up
Parents' perceived barriers in communicating with their children regarding pregnancy prevention and contraception
Time frame: 4-week posttest and 8-week follow-up
Parents' perception of importance of communicating with their teen about sexuality and related topics
Time frame: 4-week posttest and 8-week follow-up
Parents' knowledge of parent-teen communication about sexuality, birth control, and preventing sexually transmitted infections.
Time frame: 4-week posttest and 8-week follow-up
Users' perception of program usability
Time frame: 4-week posttest
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 10 Nov 2015.
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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.
Susan Schroeder, MPH, MCHES principal investigator
Oregon Center for Applied Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Let's Talk About Sex and Websites; preventing teen pregnancy in people with Adolescent Pregnancy and Sexually Transmitted Diseases, run by Oregon Center for Applied Science, Inc. 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 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: finished, as of the sponsor's last update on 10 Nov 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?
Behavioral activation as measured by the Parent-Teen Sexual Risk Communication Scale (time frame: 8-week follow-up). 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 10 Nov 2015.