Louisville Teen Pregnancy Prevention Project (CHAMPS)
2017年4月20日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (実際)
1450
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Kentucky
-
Louisville、Kentucky、アメリカ、40203
- Department for Community Based Services: Jefferson County Region
-
Louisville、Kentucky、アメリカ、40203
- House of Ruth
-
Louisville、Kentucky、アメリカ、40203
- Presbyterian Community Center
-
Louisville、Kentucky、アメリカ、40205
- Jewish Family and Career Services
-
Louisville、Kentucky、アメリカ、40207
- Gate of Hope Ministries
-
Louisville、Kentucky、アメリカ、40210
- St George Community Center
-
Louisville、Kentucky、アメリカ、40212
- Neighborhood House
-
Louisville、Kentucky、アメリカ、40212
- One Plus One Equals You
-
Louisville、Kentucky、アメリカ、40214
- Americana Community Center
-
Louisville、Kentucky、アメリカ、40218
- Canaan Community Development Corporation
-
Louisville、Kentucky、アメリカ、40223
- Maryhurst
-
Louisville、Kentucky、アメリカ、40259
- The Steward's Staff
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
14年～19年 (子、大人)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
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.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：防止
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Reducing the Risk
Students will be randomly assigned to participate in Reducing the Risk training
|
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).
他の名前：
|
|
実験的：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).
|
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Pregnancy
時間枠：2 years
|
Number of girls that get pregnant.
Number of girls and times boys impregnate someone.
|
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
number and type of STIs contracted
時間枠：2 years
|
Number of sexually transmitted infections participants contract
|
2 years
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Anita P Barbee, Ph.D.、Kent School of Social Work University of Louisville
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年9月1日
一次修了 (実際)
2014年3月1日
研究の完了 (実際)
2016年4月1日
試験登録日
最初に提出
2011年8月4日
QC基準を満たした最初の提出物
2011年8月5日
最初の投稿 (見積もり)
2011年8月8日
学習記録の更新
投稿された最後の更新 (実際)
2017年4月24日
QC基準を満たした最後の更新が送信されました
2017年4月20日
最終確認日
2017年4月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。