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Louisville Teen Pregnancy Prevention Project (CHAMPS)

20. april 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

1450

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Kentucky
      • Louisville, Kentucky, Forente stater, 40203
        • Department for Community Based Services: Jefferson County Region
      • Louisville, Kentucky, Forente stater, 40203
        • House of Ruth
      • Louisville, Kentucky, Forente stater, 40203
        • Presbyterian Community Center
      • Louisville, Kentucky, Forente stater, 40205
        • Jewish Family and Career Services
      • Louisville, Kentucky, Forente stater, 40207
        • Gate of Hope Ministries
      • Louisville, Kentucky, Forente stater, 40210
        • St George Community Center
      • Louisville, Kentucky, Forente stater, 40212
        • Neighborhood House
      • Louisville, Kentucky, Forente stater, 40212
        • One Plus One Equals You
      • Louisville, Kentucky, Forente stater, 40214
        • Americana Community Center
      • Louisville, Kentucky, Forente stater, 40218
        • Canaan Community Development Corporation
      • Louisville, Kentucky, Forente stater, 40223
        • Maryhurst
      • Louisville, Kentucky, Forente stater, 40259
        • The Steward's Staff

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

14 år til 19 år (Barn, Voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Forebygging
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: Reducing the Risk
Students will be randomly assigned to participate in Reducing the Risk training
Atferdsmessig: Reducing the Risk
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).
Andre navn:
  • Comprehensive Sex Ed
Eksperimentell: 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).
Atferdsmessig: 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). This curriculum builds on social exchange theory and meets the needs of youth who are alienated and in need of loving personal relationships.
Andre navn:
  • Relationship Ed

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Pregnancy
Tidsramme: 2 years
Number of girls that get pregnant. Number of girls and times boys impregnate someone.
2 years

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
number and type of STIs contracted
Tidsramme: 2 years
Number of sexually transmitted infections participants contract
2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Louisville

Samarbeidspartnere

Department of Health and Human Services

Etterforskere

  • Hovedetterforsker: Anita P Barbee, Ph.D., Kent School of Social Work University of Louisville

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2011

Primær fullføring (Faktiske)

1. mars 2014

Studiet fullført (Faktiske)

1. april 2016

Datoer for studieregistrering

Først innsendt

4. august 2011

Først innsendt som oppfylte QC-kriteriene

5. august 2011

Først lagt ut (Anslag)

8. august 2011

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. april 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. april 2017

Sist bekreftet

1. april 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • TP2AH000010-01-00

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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Sponsorer og samarbeidspartnere

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Legemiddelintervensjoner

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Forhold

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Steder

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