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Louisville Teen Pregnancy Prevention Project (CHAMPS)

20 april 2017 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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

Ingrijpend

Inschrijving (Werkelijk)

1450

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

14 jaar tot 19 jaar (Kind, Volwassen)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Reducing the Risk
Students will be randomly assigned to participate in Reducing the Risk training
Gedragsmatig: 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).
Andere namen:
  • Comprehensive Sex Ed
Experimenteel: 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).
Gedragsmatig: 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.
Andere namen:
  • Relationship Ed

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Pregnancy
Tijdsspanne: 2 years
Number of girls that get pregnant. Number of girls and times boys impregnate someone.
2 years

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
number and type of STIs contracted
Tijdsspanne: 2 years
Number of sexually transmitted infections participants contract
2 years

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Louisville

Medewerkers

Department of Health and Human Services

Onderzoekers

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

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2011

Primaire voltooiing (Werkelijk)

1 maart 2014

Studie voltooiing (Werkelijk)

1 april 2016

Studieregistratiedata

Eerst ingediend

4 augustus 2011

Eerst ingediend dat voldeed aan de QC-criteria

5 augustus 2011

Eerst geplaatst (Schatting)

8 augustus 2011

Updates van studierecords

Laatste update geplaatst (Werkelijk)

24 april 2017

Laatste update ingediend die voldeed aan QC-criteria

20 april 2017

Laatst geverifieerd

1 april 2017

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • TP2AH000010-01-00

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Klinische onderzoeken op Seksueel overdraagbare aandoeningen

Klinische onderzoeken op Reducing the Risk

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