Louisville Teen Pregnancy Prevention Project (CHAMPS)
20 de abril de 2017 actualizado por: Anita Barbee, University of Louisville
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.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
1450
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Kentucky
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Louisville, Kentucky, Estados Unidos, 40203
- Department for Community Based Services: Jefferson County Region
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Louisville, Kentucky, Estados Unidos, 40203
- House of Ruth
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Louisville, Kentucky, Estados Unidos, 40203
- Presbyterian Community Center
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Louisville, Kentucky, Estados Unidos, 40205
- Jewish Family and Career Services
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Louisville, Kentucky, Estados Unidos, 40207
- Gate of Hope Ministries
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Louisville, Kentucky, Estados Unidos, 40210
- St George Community Center
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Louisville, Kentucky, Estados Unidos, 40212
- Neighborhood House
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Louisville, Kentucky, Estados Unidos, 40212
- One Plus One Equals You
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Louisville, Kentucky, Estados Unidos, 40214
- Americana Community Center
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Louisville, Kentucky, Estados Unidos, 40218
- Canaan Community Development Corporation
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Louisville, Kentucky, Estados Unidos, 40223
- Maryhurst
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Louisville, Kentucky, Estados Unidos, 40259
- The Steward's Staff
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
14 años a 19 años (Niño, Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Reducing the Risk
Students will be randomly assigned to participate in Reducing the Risk training
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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).
Otros nombres:
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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).
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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.
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Pregnancy
Periodo de tiempo: 2 years
|
Number of girls that get pregnant.
Number of girls and times boys impregnate someone.
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2 years
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
number and type of STIs contracted
Periodo de tiempo: 2 years
|
Number of sexually transmitted infections participants contract
|
2 years
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anita P Barbee, Ph.D., Kent School of Social Work University of Louisville
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de septiembre de 2011
Finalización primaria (Actual)
1 de marzo de 2014
Finalización del estudio (Actual)
1 de abril de 2016
Fechas de registro del estudio
Enviado por primera vez
4 de agosto de 2011
Primero enviado que cumplió con los criterios de control de calidad
5 de agosto de 2011
Publicado por primera vez (Estimar)
8 de agosto de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
24 de abril de 2017
Última actualización enviada que cumplió con los criterios de control de calidad
20 de abril de 2017
Última verificación
1 de abril de 2017
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TP2AH000010-01-00
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