Louisville Teen Pregnancy Prevention Project

Pregnancy Clinical Trial

— CHAMPS  

Official title:

Creating Healthy Adolescents Through Meaningful Prevention Services

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411878
• Other study ID #: TP2AH000010-01-00
• Status: Completed
• Phase: N/A
• First received: August 4, 2011
• Last updated: April 20, 2017
• Start date: September 2011
• Est. completion date: April 2016

Study information

• Verified date: April 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1450
• Est. completion date: April 2016
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pregnancy
• Sexually Transmitted Diseases

Intervention

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).
• 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.

Locations

Country	Name	City	State
United States	Americana Community Center	Louisville	Kentucky
United States	Canaan Community Development Corporation	Louisville	Kentucky
United States	Department for Community Based Services: Jefferson County Region	Louisville	Kentucky
United States	Gate of Hope Ministries	Louisville	Kentucky
United States	House of Ruth	Louisville	Kentucky
United States	Jewish Family and Career Services	Louisville	Kentucky
United States	Maryhurst	Louisville	Kentucky
United States	Neighborhood House	Louisville	Kentucky
United States	One Plus One Equals You	Louisville	Kentucky
United States	Presbyterian Community Center	Louisville	Kentucky
United States	St George Community Center	Louisville	Kentucky
United States	The Steward's Staff	Louisville	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy	Number of girls that get pregnant. Number of girls and times boys impregnate someone.	2 years
Secondary	number and type of STIs contracted	Number of sexually transmitted infections participants contract	2 years