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- Ensaio Clínico NCT03311061
Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS)
Evaluation of Curriculum for Teen Pregnancy Prevention: Decisions, Responsibility, Empowerment, Accountability, Motivations & Success (DREAMS) in Houston TX
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Texas
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Houston, Texas, Estados Unidos, 77036
- Bee Busy Inc.
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Age 13-19; enrolled in participating high school health class; passive consent received;
Exclusion Criteria:
Students who enrolled in classes post baseline. Students who had previously failed the HS course and was already exposed to DREAMS curriculum.
Plano de estudo
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 |
---|---|
Experimental: DREAMS
The experimental group will be exposed to the DREAMS curriculum including the supplemental technology based application.It is composed of 10 modules: Introduction; Self Exploration; Healthy Relationships; Adolescent Sexuality; Attitudes and Adolescent Sexual Activity; Consequences of Sex - HIV/STI; Consequences of Sex - Pregnancy; Managing Pressure to Engage in Sexual Activity through the Lens of Social Media; Financial Literacy; Careers; Post secondary Education; Wrap up and Close Out. The technology app will include curriculum support and additional resources. Students will have access to the mobile app after the in school programming ends. The intent is for students to have access to portions of the app that deal with self developed goals and progress monitoring for goals, and resource material. This is similar to a student having continued access to a textbook/other class materials. |
Teen Pregnancy Prevention Curriculum as described in arm/group description.
|
Comparador Ativo: Non DREAMS
The control group experience will include health curriculum already adopted by the school district.
Continued services as usual.
The control group schools, for the most part, lack any formal pregnancy prevention services.
All schools claim that lessons developed by the teachers meet the Texas Essential Knowledge Standards (TEKS).
No outside services are provided to students and school based services are limited.
The services offered at the schools is predominately abstinence based.
Students attending the schools would need to initiate any services that are available within the community.
The control group will not have access to the DREAMS curriculum or the technology-based application to enhance the DREAMS curriculum.
The technology-based application will be a closed, password protected, system during the research trial.
|
Teen Pregnancy Prevention Curriculum as described in arm/group description.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of participants who had sex without a condom
Prazo: immediately post-intervention, 6-months and 12-months-post intervention
|
Number of participants who had sex without a condom.
The relative difference of condom usage during penile-vaginal sex acts in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.
|
immediately post-intervention, 6-months and 12-months-post intervention
|
Number of participants who ever had sex
Prazo: immediately post-intervention, 6-months and 12-months-post intervention
|
Number of participants who ever had sex.
The relative difference of ever having sex (penile-vaginal sex acts) in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.
|
immediately post-intervention, 6-months and 12-months-post intervention
|
Number of penile-vaginal sex acts
Prazo: immediately post-intervention, 6-months and 12-months-post intervention
|
Number of penile-vaginal sex acts.
The relative difference of the number of penile-vaginal sex acts in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.
|
immediately post-intervention, 6-months and 12-months-post intervention
|
Number of participants who used other birth control methods
Prazo: immediately post-intervention, 6-months and 12-months-post intervention
|
Number of participants who used other birth control methods.
The relative difference of birth control methods (e.g., the pill, the patch) during penile-vaginal sex acts in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.
|
immediately post-intervention, 6-months and 12-months-post intervention
|
Number of participants who had an STI
Prazo: immediately post-intervention, 6-months and 12-months-post intervention
|
Number of participants who had an STI.
The relative difference of reported STI in the intervention versus control group at post-intervention, 6-months and 12-months post-intervention.
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immediately post-intervention, 6-months and 12-months-post intervention
|
Number of participants who increased knowledge concerning risks associated with unprotected sex
Prazo: immediately post intervention
|
Number of participants who increased knowledge concerning risks associated with unprotected sex.
The relative difference of knowledge gained in the intervention versus control group at immediately post-intervention.
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immediately post intervention
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy
Prazo: 12-months-post intervention
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Number of participants (by gender, age, and race/ethnicity) who had had a teenage pregnancy.
The relative difference of teenage pregnancies (among genders, ages, and race/ethnicity) in the intervention versus control group at 12-months post-intervention.
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12-months-post intervention
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Number of participants who had had a teenage pregnancy
Prazo: 12-months-post intervention
|
Number of participants who had had a teenage pregnancy.
The relative difference of teenage pregnancies in the intervention versus control group at 12-months post-intervention.
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12-months-post intervention
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Antecipado)
Conclusão do estudo (Antecipado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- 00004955
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Informações sobre medicamentos e dispositivos, documentos de estudo
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Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
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