PregnancyCHAMPSNCT01411878
Louisville Teen Pregnancy Prevention Project
A study testing Reducing the Risk and Love Notes in people with Pregnancy and Sexually Transmitted Diseases, run by University of Louisville at 12 sites in United States.
Trial summary
This study is comparing the impact of two teen pregnancy prevention interventions, Reducing the Risk and Love Note with a non-related training on community building to determine which is most effective for which participants in delaying sexual initiation, enhancing use of condoms and other forms of birth control… Read more about this study
- Who is it for?
- Ages 14 to 19 yearsHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Sexually Transmitted Diseases
- What is being tested?
- Reducing the Risk and Love Notes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,450 participants
- Where
- 12 sitesUnited States
- Study dates
- Sep 2011to Apr 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 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Parental Informed Consent for enrollment in the CHAMPS! CAMP and accompanying research sessions,
- Personal assent for participation in the workshop and research sessions.
- Age 14 to 19 years old ;
- Affiliation with youth serving organizations, or part of a current foster youth or former foster youth alumni group.
Who cannot join
- Age 13 or younger, 20 or older;
- Married
- Inability to participate verbally in English;
- Cognitive impairment that precludes the subject from giving assent or informed consent for any reason;
- Refusal of consent to participate in the study by their parent.
- Already pregnant or a parent, because we are attempting primary prevention.
- Prior participation in a comparable local program, such as Love U2.
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
Department for Community Based Services: Jefferson County Region
Louisville, Kentucky, 40203
House of Ruth
Louisville, Kentucky, 40203
Presbyterian Community Center
Louisville, Kentucky, 40203
Jewish Family and Career Services
Louisville, Kentucky, 40205
Gate of Hope Ministries
Louisville, Kentucky, 40207
St George Community Center
Louisville, Kentucky, 40210
Neighborhood House
Louisville, Kentucky, 40212
One Plus One Equals You
Louisville, Kentucky, 40212
Americana Community Center
Louisville, Kentucky, 40214
Canaan Community Development Corporation
Louisville, Kentucky, 40218
Maryhurst
Louisville, Kentucky, 40223
The Steward's Staff
Louisville, Kentucky, 40259
About this study
Official title: Creating Healthy Adolescents Through Meaningful Prevention Services
This study is comparing the impact of two teen pregnancy prevention interventions, Reducing the Risk and Love Note with a non-related training on community building to determine which is most effective for which participants in delaying sexual initiation, enhancing use of condoms and other forms of birth control, decreasing sexually transmitted diseases and decreasing the number of pregnancies. The participants were 1450 youth between the ages of 14 and 19 including those from poor urban settings, those from immigrant and refugee families and those from the foster care system. Both girls and boys were be in the study. The investigators predict that girls, immigrants and refugees and foster youth will have better outcomes when participating in Love Notes, a program focused on healthy relationship formation and maintenance as a frame for how to manage the sexual aspect of relationships while boys and urban youth will have better outcomes when participating in Reducing the Risk. Both groups will have better outcomes than those in the control condition.
Read the detailed description
The purpose of this research is to conduct a randomized controlled trial with three groups to test the effectiveness of various interventions aimed at reducing risky behavior by teenagers. Two intervention groups will each receive a training intervention to reduce the chances of teen pregnancy, contraction of STIs, and abusive relationships among high risk youth in the Louisville community. The wait-list control group will receive training on the unrelated topic of community building at the same time. According to the Centers for Disease Control (CDC) Youth Risk Behavior Surveillance System (YRBSS), 50% of Kentucky high school students have participated in sexual intercourse, 37% report currently being sexually active, and 14% have reported having sexual intercourse with four or more sexual partners. Furthermore, only 41% of sexually active students reported using a condom the last time they had sex. These are risky sexual practices that may lead to HIV/STI infection, as well as unintended pregnancy, within the adolescent population. Understanding the pregnancy intentions of these adolescents is not only important with regards to adolescent pregnancy, but it is also important in light of HIV and STI infection when 6% of adolescents and young adults (<20 years of age) in Kentucky have been reported as HIV positive since 2009. As of January 2009, Kentucky ranked 42nd for teenage births (where 1 is best) with a teenage birth rate of 56 per 1,000 girls ages 15-19 years of age. Kentucky was only slightly above Mississippi, which ranked 50th with a teenage birth rate of 68.4 per 1,000. Kentucky's teenage birth rate is higher than the national rate which is currently 41.9 per 1,000 girls ages 15-19 years of age. The most recent Kentucky teen birth rates in 2007 show that Jefferson County (52.34 per 1,000 ages 15-19) exceeds the birth rate of the nation. To address these issues, 1450 Louisville youth were given the opportunity to participate in one of two intervention curricula: called Reducing the Risk and Love Notes, or a waiting list control condition.
- Conditions
- Pregnancy, Sexually Transmitted Diseases
- Being tested
- Reducing the Risk, Love Notes
- Keywords
- Teen Pregnancy Prevention
- Medical subject headings
- Sexually Transmitted Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing the RiskBehavioural
Also called Comprehensive Sex Ed
Reducing the Risk: Building Skills to Prevent Pregnancy, STD and HIV (RtR) was developed by Richard Barth, MSW, Ph.D. in California. The training manual is in its 5th Edition and was last published in 2011. This curriculum is one of the first that was evaluated using an experimental design, with a longitudinal follow up (6 months and 18 months) and tested on a large group of high school students (N = 758). It is also one of the first programs to show an impact on beliefs of adolescent sexual behavior prevalence and actual behavior as well as increasing parent-child communication about abstinence and contraception (Kirby, Barth, Leland, and Fetro, 1991).
Love NotesBehavioural
Also called Relationship Ed
The second healthy relationships program for high-risk youth, Love Notes, was developed to educate participants about healthy relationships, including issues of decision-making, communication and conflict resolution, and overall safety, including the prevention of pregnancy and sexually transmitted disease (Pearson, 2009). Love Notes is a derivative of the Prevention and Relationship Enhancement Program (PREP; Stanley, Markman, \& Jenkins, 2009), which is relationship marriage education program listed as an evidence-based practice (EBP) by SAMSHA (www.samhsa.gov). This curriculum builds on social exchange theory and meets the needs of youth who are alienated and in need of loving personal relationships.
| Study group | Role | What they receive |
|---|---|---|
| Reducing the Risk | Experimental | Students will be randomly assigned to participate in Reducing the Risk training Receives: Behavioral: Reducing the Risk |
| Love Notes | Experimental | The second healthy relationships program for high-risk youth, Love Notes, was developed to educate participants about healthy relationships, including issues of decision-making, communication and conflict resolution, and overall safety, including the prevention of pregnancy and sexually transmitted disease (Pearson, 2009). Love Notes is a derivative of the Prevention and Relationship Enhancement Program (PREP; Stanley, Markman, \& Jenkins, 2009), which is relationship marriage education program listed as an evidence-based practice (EBP) by SAMSHA (www.samhsa.gov). Receives: Behavioral: Love Notes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy
Number of girls that get pregnant. Number of girls and times boys impregnate someone.
Measured: 2 years
Secondary outcomes (1)
number and type of STIs contracted
Number of sexually transmitted infections participants contract
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionMar 2014
- Study completionApr 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 PregnancyStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,450 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Anita Barbee, University of Louisville
- Investigators
- Anita P Barbee, Ph.D., Principal investigator, Kent School of Social Work University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411878
- Sponsor's protocol ID
- TP2AH000010-01-00
- Acronym
- CHAMPS
- Status last verified
- Apr 2017
- First submitted
- 4 Aug 2011
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Barbee AP, Cunningham MR, van Zyl MA, Antle BF, Langley CN. Impact of Two Adolescent Pregnancy Prevention Interventions on Risky Sexual Behavior: A Three-Arm Cluster Randomized Control Trial. Am J Public Health. 2016 Sep;106(S1):S85-S90. doi: 10.2105/AJPH.2016.303429.
PubMed 27689500
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating Healthy Adolescents Through Meaningful Prevention Services
- ClinicalTrials.gov ID
- NCT01411878
- Acronym / sponsor ID
- CHAMPS / TP2AH000010-01-00
- Conditions
- Pregnancy, Sexually Transmitted Diseases
- Keywords
- Teen Pregnancy Prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,450 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- Sep 2011
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 8 Aug 2011 (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.
This study is comparing the impact of two teen pregnancy prevention interventions, Reducing the Risk and Love Note with a non-related training on community building to determine which is most effective for which participants in delaying sexual initiation, enhancing use of condoms and other forms of birth control, decreasing sexually transmitted diseases and decreasing the number of pregnancies. The participants were 1450 youth between the ages of 14 and 19 including those from poor urban settings, those from immigrant and refugee families and those from the foster care system. Both girls and boys were be in the study. The investigators predict that girls, immigrants and refugees and foster youth will have better outcomes when participating in Love Notes, a program focused on healthy relationship formation and maintenance as a frame for how to manage the sexual aspect of relationships while boys and urban youth will have better outcomes when participating in Reducing the Risk. Both groups will have better outcomes than those in the control condition.
Detailed description
The purpose of this research is to conduct a randomized controlled trial with three groups to test the effectiveness of various interventions aimed at reducing risky behavior by teenagers. Two intervention groups will each receive a training intervention to reduce the chances of teen pregnancy, contraction of STIs, and abusive relationships among high risk youth in the Louisville community. The wait-list control group will receive training on the unrelated topic of community building at the same time. According to the Centers for Disease Control (CDC) Youth Risk Behavior Surveillance System (YRBSS), 50% of Kentucky high school students have participated in sexual intercourse, 37% report currently being sexually active, and 14% have reported having sexual intercourse with four or more sexual partners. Furthermore, only 41% of sexually active students reported using a condom the last time they had sex. These are risky sexual practices that may lead to HIV/STI infection, as well as unintended pregnancy, within the adolescent population. Understanding the pregnancy intentions of these adolescents is not only important with regards to adolescent pregnancy, but it is also important in light of HIV and STI infection when 6% of adolescents and young adults (<20 years of age) in Kentucky have been reported as HIV positive since 2009. As of January 2009, Kentucky ranked 42nd for teenage births (where 1 is best) with a teenage birth rate of 56 per 1,000 girls ages 15-19 years of age. Kentucky was only slightly above Mississippi, which ranked 50th with a teenage birth rate of 68.4 per 1,000. Kentucky's teenage birth rate is higher than the national rate which is currently 41.9 per 1,000 girls ages 15-19 years of age. The most recent Kentucky teen birth rates in 2007 show that Jefferson County (52.34 per 1,000 ages 15-19) exceeds the birth rate of the nation. To address these issues, 1450 Louisville youth were given the opportunity to participate in one of two intervention curricula: called Reducing the Risk and Love Notes, or a waiting list control condition.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reducing the Risk | Experimental | Behavioral: Reducing the RiskStudents will be randomly assigned to participate in Reducing the Risk training |
| Love Notes | Experimental | Behavioral: Love NotesThe second healthy relationships program for high-risk youth, Love Notes, was developed to educate participants about healthy relationships, including issues of decision-making, communication and conflict resolution, and overall safety, including the prevention of pregnancy and sexually transmitted disease (Pearson, 2009). Love Notes is a derivative of the Prevention and Relationship Enhancement Program (PREP; Stanley, Markman, \& Jenkins, 2009), which is relationship marriage education program listed as an evidence-based practice (EBP) by SAMSHA (www.samhsa.gov). |
Who may qualify
- Ages
- 14 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Parental Informed Consent for enrollment in the CHAMPS! CAMP and accompanying research sessions,
- Personal assent for participation in the workshop and research sessions.
- Age 14 to 19 years old ;
- Affiliation with youth serving organizations, or part of a current foster youth or former foster youth alumni group.
Key exclusion criteria (7 listed)
- Age 13 or younger, 20 or older;
- Married
- Inability to participate verbally in English;
- Cognitive impairment that precludes the subject from giving assent or informed consent for any reason;
- Refusal of consent to participate in the study by their parent.
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 |
|---|---|---|
| Reducing the RiskAlso: Comprehensive Sex EdReducing the Risk: Building Skills to Prevent Pregnancy, STD and HIV (RtR) was developed by Richard Barth, MSW, Ph.D. in California. The training manual is in its 5th Edition and was last published in 2011. This curriculum is one of the first that was evaluated using an experimental design, with a longitudinal follow up (6 months and 18 months) and tested on a large group of high school students (N = 758). It is also one of the first programs to show an impact on beliefs of adolescent sexual behavior prevalence and actual behavior as well as increasing parent-child communication about abstinence and contraception (Kirby, Barth, Leland, and Fetro, 1991). | Behavioural | Reducing the Risk |
| Love NotesAlso: Relationship EdThe second healthy relationships program for high-risk youth, Love Notes, was developed to educate participants about healthy relationships, including issues of decision-making, communication and conflict resolution, and overall safety, including the prevention of pregnancy and sexually transmitted disease (Pearson, 2009). Love Notes is a derivative of the Prevention and Relationship Enhancement Program (PREP; Stanley, Markman, \& Jenkins, 2009), which is relationship marriage education program listed as an evidence-based practice (EBP) by SAMSHA (www.samhsa.gov). This curriculum builds on social exchange theory and meets the needs of youth who are alienated and in need of loving personal relationships. | Behavioural | Love Notes |
Primary outcome
Pregnancy
Time frame: 2 years
Number of girls that get pregnant. Number of girls and times boys impregnate someone.
1 secondary outcome
number and type of STIs contracted
Time frame: 2 years
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 24 Apr 2017.
- Results publication: PubMed 27689500Barbee AP, Cunningham MR, van Zyl MA, Antle BF, Langley CN. Impact of Two Adolescent Pregnancy Prevention Interventions on Risky Sexual Behavior: A Three-Arm Cluster Randomized Control Trial. Am J Public Health. 2016 Sep;106(S1):S85-S90. doi: 10.2105/AJPH.2016.303429.
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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.
Anita P Barbee, Ph.D. principal investigator
Kent School of Social Work University of Louisville
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing the Risk and Love Notes in people with Pregnancy and Sexually Transmitted Diseases, run by University of Louisville at 12 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 4 inclusion and 7 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 24 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 12 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?
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: 2 years). 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 NCT01411878, 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 24 Apr 2017.