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Louisville Teen Pregnancy Prevention Project (CHAMPS)

Primary Purpose

Pregnancy, Sexually Transmitted Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reducing the Risk
Love Notes
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pregnancy focused on measuring Teen Pregnancy Prevention

Eligibility Criteria

14 Years - 19 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Reducing the Risk

Love Notes

Arm Description

Students will be randomly assigned to participate in Reducing the Risk training

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).

Outcomes

Primary Outcome Measures

Pregnancy
Number of girls that get pregnant. Number of girls and times boys impregnate someone.

Secondary Outcome Measures

number and type of STIs contracted
Number of sexually transmitted infections participants contract

Full Information

First Posted
August 4, 2011
Last Updated
April 20, 2017
Sponsor
University of Louisville
Collaborators
Department of Health and Human Services
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1. Study Identification

Unique Protocol Identification Number
NCT01411878
Brief Title
Louisville Teen Pregnancy Prevention Project
Acronym
CHAMPS
Official Title
Creating Healthy Adolescents Through Meaningful Prevention Services
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
Department of Health and Human Services

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy, Sexually Transmitted Diseases
Keywords
Teen Pregnancy Prevention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
1450 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reducing the Risk
Arm Type
Experimental
Arm Description
Students will be randomly assigned to participate in Reducing the Risk training
Arm Title
Love Notes
Arm Type
Experimental
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Reducing the Risk
Other Intervention Name(s)
Comprehensive Sex Ed
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Love Notes
Other Intervention Name(s)
Relationship Ed
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pregnancy
Description
Number of girls that get pregnant. Number of girls and times boys impregnate someone.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
number and type of STIs contracted
Description
Number of sexually transmitted infections participants contract
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita P Barbee, Ph.D.
Organizational Affiliation
Kent School of Social Work University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department for Community Based Services: Jefferson County Region
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40203
Country
United States
Facility Name
House of Ruth
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40203
Country
United States
Facility Name
Presbyterian Community Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40203
Country
United States
Facility Name
Jewish Family and Career Services
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40205
Country
United States
Facility Name
Gate of Hope Ministries
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
St George Community Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40210
Country
United States
Facility Name
Neighborhood House
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40212
Country
United States
Facility Name
One Plus One Equals You
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40212
Country
United States
Facility Name
Americana Community Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40214
Country
United States
Facility Name
Canaan Community Development Corporation
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40218
Country
United States
Facility Name
Maryhurst
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40223
Country
United States
Facility Name
The Steward's Staff
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40259
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27689500
Citation
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.
Results Reference
result

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Louisville Teen Pregnancy Prevention Project

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