Louisville Teen Pregnancy Prevention Project (CHAMPS)

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Anita Barbee, University of Louisville
ClinicalTrials.gov Identifier:
NCT01411878
First received: August 4, 2011
Last updated: September 6, 2011
Last verified: September 2011
  Purpose

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 will be 1300 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 will 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.


Condition Intervention Phase
Pregnancy
Sexually Transmitted Diseases
Behavioral: Reducing the Risk
Behavioral: Love Notes
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Creating Healthy Adolescents Through Meaningful Prevention Services

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Pregnancy [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Number of girls that get pregnant. Number of girls and times boys impregnate someone.


Secondary Outcome Measures:
  • number and type of STIs contracted [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
    Number of sexually transmitted infections participants contract


Estimated Enrollment: 1300
Study Start Date: September 2011
Estimated Study Completion Date: April 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Reducing the Risk
Students will be randomly assigned to participate in Reducing the Risk training
Behavioral: Reducing the Risk
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).
Other Name: Comprehensive Sex Ed
Experimental: Love Notes
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).
Behavioral: Love Notes
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.
Other Name: Relationship Ed

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, 1300 Louisville youth will be given the opportunity to participate in one of two intervention curricula: called Reducing the Risk and Love Notes, or a waiting list control condition.

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Parental Informed Consent for enrollment in the CHAMPS! CAMP and accompanying research sessions,
  2. Personal assent for participation in the workshop and research sessions.
  3. Age 14 to 19 years old ;
  4. Affiliation with youth serving organizations, or part of a current foster youth or former foster youth alumni group.

Exclusion Criteria:

  1. Age 13 or younger, 20 or older;
  2. Married
  3. Inability to participate verbally in English;
  4. Cognitive impairment that precludes the subject from giving assent or informed consent for any reason;
  5. Refusal of consent to participate in the study by their parent.
  6. Already pregnant or a parent, because we are attempting primary prevention.
  7. Prior participation in a comparable local program, such as Love U2.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01411878

Locations
United States, Kentucky
Americana Community Center
Louisville, Kentucky, United States, 40214
Canaan Community Development Corporation
Louisville, Kentucky, United States, 40218
Department for Community Based Services: Jefferson County Region
Louisville, Kentucky, United States, 40203
Gate of Hope Ministries
Louisville, Kentucky, United States, 40207
House of Ruth
Louisville, Kentucky, United States, 40203
Jewish Family and Career Services
Louisville, Kentucky, United States, 40205
Maryhurst
Louisville, Kentucky, United States, 40223
Neighborhood House
Louisville, Kentucky, United States, 40212
One Plus One Equals You
Louisville, Kentucky, United States, 40212
Presbyterian Community Center
Louisville, Kentucky, United States, 40203
St George Community Center
Louisville, Kentucky, United States, 40210
The Steward's Staff
Louisville, Kentucky, United States, 40259
Sponsors and Collaborators
University of Louisville
Investigators
Principal Investigator: Anita P Barbee, Ph.D. Kent School of Social Work University of Louisville
  More Information

No publications provided

Responsible Party: Anita Barbee, Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT01411878     History of Changes
Other Study ID Numbers: TP2AH000010-01-00
Study First Received: August 4, 2011
Last Updated: September 6, 2011
Health Authority: United States: Federal Government

Keywords provided by University of Louisville:
Teen Pregnancy Prevention

Additional relevant MeSH terms:
Sexually Transmitted Diseases
Infection
Virus Diseases
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014