Louisville Teen Pregnancy Prevention Project (CHAMPS)
20 de abril de 2017 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
1450
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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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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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
14 anos a 19 anos (Filho, Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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).
Outros nomes:
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Pregnancy
Prazo: 2 years
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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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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number and type of STIs contracted
Prazo: 2 years
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Number of sexually transmitted infections participants contract
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2 years
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anita P Barbee, Ph.D., Kent School of Social Work University of Louisville
Publicações e links úteis
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Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de setembro de 2011
Conclusão Primária (Real)
1 de março de 2014
Conclusão do estudo (Real)
1 de abril de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
4 de agosto de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de agosto de 2011
Primeira postagem (Estimativa)
8 de agosto de 2011
Atualizações de registro de estudo
Última Atualização Postada (Real)
24 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
20 de abril de 2017
Última verificação
1 de abril de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TP2AH000010-01-00
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