Louisville Teen Pregnancy Prevention Project
CHAMPS
Creating Healthy Adolescents Through Meaningful Prevention Services
1 other identifier
interventional
1,450
1 country
12
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable pregnancy
Started Sep 2011
Longer than P75 for not_applicable pregnancy
12 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 4, 2011
CompletedFirst Posted
Study publicly available on registry
August 8, 2011
CompletedStudy Start
First participant enrolled
September 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedApril 24, 2017
April 1, 2017
2.5 years
August 4, 2011
April 20, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pregnancy
Number of girls that get pregnant. Number of girls and times boys impregnate someone.
2 years
Secondary Outcomes (1)
number and type of STIs contracted
2 years
Study Arms (2)
Reducing the Risk
EXPERIMENTALStudents will be randomly assigned to participate in Reducing the Risk training
Love Notes
EXPERIMENTALThe 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).
Interventions
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).
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Louisvillelead
- Department of Health and Human Servicescollaborator
Study Sites (12)
Department for Community Based Services: Jefferson County Region
Louisville, Kentucky, 40203, United States
House of Ruth
Louisville, Kentucky, 40203, United States
Presbyterian Community Center
Louisville, Kentucky, 40203, United States
Jewish Family and Career Services
Louisville, Kentucky, 40205, United States
Gate of Hope Ministries
Louisville, Kentucky, 40207, United States
St George Community Center
Louisville, Kentucky, 40210, United States
Neighborhood House
Louisville, Kentucky, 40212, United States
One Plus One Equals You
Louisville, Kentucky, 40212, United States
Americana Community Center
Louisville, Kentucky, 40214, United States
Canaan Community Development Corporation
Louisville, Kentucky, 40218, United States
Maryhurst
Louisville, Kentucky, 40223, United States
The Steward's Staff
Louisville, Kentucky, 40259, United States
Related 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. doi: 10.2105/AJPH.2016.303429.
PMID: 27689500RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anita P Barbee, Ph.D.
Kent School of Social Work University of Louisville
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 4, 2011
First Posted
August 8, 2011
Study Start
September 1, 2011
Primary Completion
March 1, 2014
Study Completion
April 1, 2016
Last Updated
April 24, 2017
Record last verified: 2017-04