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A Parent-Based Intervention to Reduce Sexual Risk Behavior in Adolescents

2022年10月25日 更新者:New York University

Reducing Teen Sexual Behavior: A Clinic-Based Approach

The purpose of this study is to test the feasibility and efficacy of a triadic intervention designed to target both healthcare providers and parents in order to prevent adolescent sexual risk behavior in Latino and African American adolescents. The intervention will be administered in the context of mothers waiting for their children to complete a non-acute care visit.

調査の概要

詳細な説明

In the United States, racial and ethnic minorities suffer disproportionately from preventable diseases and conditions. Many of these problems result from health-related behaviors that are established during childhood and adolescence. Latino and African-American adolescents are at considerable risk for the negative consequences of early, risky sexual activity. This study will focus on Latino and African-American early adolescents ages 11 to 14.

The primary aim for this study will be to test and refine a triadic intervention developed for healthcare providers and parents to address the issue of sexual risk behavior among African American and Latino adolescents.

The triadic intervention will take place in a pediatric health care clinic when mothers accompany their children for a non-acute care visit. Mothers will meet with a provider extender (medical assistant, social worker, counselor) for approximately 30 minutes while their children are being examined by a healthcare provider. During this time, mothers will receive information about the problem of premature adolescent sexual activity, support in preventing or reducing their children's sexual risk behavior, instruction about how to talk with their children about sexual risk behavior, and targeted homework activities. The healthcare provider will endorse the intervention separately for mothers and adolescents. All parents will also receive one follow-up phone call to increase the probability that the homework tasks will be completed.

Participants in this study will also be assigned to one of the following three groups: an experimental group; an active control group; or a passive control group. Participants in all groups will complete three questionnaires over the course of the study to assess outcomes. Participants in the experimental and active control groups will partake in an intervention session with a provider extender. Parents in the experimental group will meet with the provider extender to discuss effective parent-adolescent communication strategies. They will also receive take-home materials to help them communicate with and parent their adolescents to reduce sexual risk behavior. Parents in the active control group will meet with the provider extender to discuss adolescent nutrition and receive informational brochures.

One booster session will take place via telephone for parents in the experimental and active control groups. The booster call will occur approximately 1 month after study entry. No such booster calls will be provided to parents in the passive control condition.

研究の種類

介入

入学 (実際)

1800

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

    • New York
      • New York、New York、アメリカ、10003
        • New York University

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

11年~14年 (子)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • Adolescents must be between the ages of 11 and 14 years old
  • Adolescent is able to agree to being a participant
  • Participant must be able to participate in questionnaire and intervention activities
  • Participant must be of Latino or African American descent

Exclusion Criteria:

  • Any cognitive or psychiatric disability that would prevent successful participation in questionnaire or intervention activities

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:Sex Education + Standard Care
Participating mothers will receive sex education information while their child is having a physical exam.
The intervention will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth fora non-acute care visit. A mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the intervention will be delivered to the mother. At the conclusion of the session, the mother will be given reference materials to take home and tasks to perform to facilitate discussions about sex with her adolescent. The healthcare provider will endorse the intervention separately for mothers and adolescents. There will be one follow-up booster session administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
アクティブコンパレータ:Hygiene & Nutrition Education + Standard Care
Participating mothers will receive information on hygiene and nutrition while their child is having a physical exam.
The active control group will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth for a non-acute care visit. The mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the active control on hygiene and nutrition will be delivered to the mother.
介入なし:No Education + Standard Care
Participating mothers who are passive controls will not receive any additional information while their child is having a physical exam.

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
時間枠
Incidence of vaginal intercourse
時間枠:Measured at 12 months post-intervention
Measured at 12 months post-intervention
Incidence of condom use
時間枠:Measured at 12-months post-intervention
Measured at 12-months post-intervention

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of sexual partners
時間枠:Measured at 12 months post-intervention
Measured at 12 months post-intervention
Behavioral intentions
時間枠:Measured at 12 months post-intervention
Behavioral intentions to engage in sexual intercourse will be assessed based on responses to three statements, each using a five point agree-disagree scale. The items are: (a) I think I am ready to have sexual intercourse; (b) I would have sexual intercourse now if I had a boy who would do it with me; and (c) I plan on having sexual intercourse in the next six months.
Measured at 12 months post-intervention
Incidence of vaginal intercourse
時間枠:Measured at 3 months post-intervention
Measured at 3 months post-intervention
Incidence of condom use
時間枠:Measured at 3 months post-intervention
Measured at 3 months post-intervention
Number of sexual partners
時間枠:Measured at 3 months post-intervention
Measured at 3 months post-intervention
Behavioral intentions
時間枠:Measured at 3 months post-intervention
Behavioral intentions to engage in sexual intercourse will be assessed based on responses to three statements, each using a five point agree-disagree scale. The items are: (a) I think I am ready to have sexual intercourse; (b) I would have sexual intercourse now if I had a boy who would do it with me; and (c) I plan on having sexual intercourse in the next six months.
Measured at 3 months post-intervention

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:Vincent Guilamo-Ramos, PhD, ANP-BC、New York University

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 (実際)

2012年2月15日

一次修了 (実際)

2016年5月31日

研究の完了 (実際)

2016年5月31日

試験登録日

最初に提出

2011年3月28日

QC基準を満たした最初の提出物

2011年3月30日

最初の投稿 (見積もり)

2011年3月31日

学習記録の更新

投稿された最後の更新 (実際)

2022年10月27日

QC基準を満たした最後の更新が送信されました

2022年10月25日

最終確認日

2019年4月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • NIH_066159
  • R01HD066159 (米国 NIH グラント/契約)

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。

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