大学生の性暴力を防ぐためのグローバルコンセント導入戦略 (SCALE)
規模: 大学生の性暴力を防ぐためのグローバルコンセント導入戦略
調査の概要
状態
条件
詳細な説明
性暴力は青少年に蔓延しており、長期にわたる健康への有害な影響のリスクを高めます。 性暴力には、自由に与えられた同意なしに人に対して行われるあらゆる性的行為が含まれます。 すべての性別が性暴力を経験する可能性がありますが、世界的に性暴力は男性よりも女性の負担となることが多く、そのような暴力を行うのは男性が最も多いです。 思春期は性暴力に対して脆弱な時期であり、米国の女子大生の約5人に1人がキャンパス内での性暴力を経験しており、被害者の91%が女性である。 大学キャンパスにおける性暴力の発生率についてはあまり知られていない。 それでもなお、複数の国にわたる大規模な調査からの推計によれば、アジア太平洋地域を含め、若い男性の性的暴力行為の報告数と若い女性の性暴力被害の報告数が高いことが確認されている。 ベトナムでは、2010年から2019年にかけて、パートナーによる生涯にわたる性暴力に関する女性の報告が増加(10%から13%)し、特に18~24歳の女性で増加(5%から14%)した。 このような傾向は、露出の変化と、セックスと性暴力についてのよりオープンな議論を反映している可能性があります。 また、ほぼ 10 人に 1 人の女性 (9%) が、15 歳以降、パートナー以外の性的暴力を受けたと報告しており、そのほとんどは家族以外の男性の知人、同僚、または見知らぬ人によって行われています。 性暴力の被害者である若い女性は、急性および慢性の精神的および身体的健康状態に陥るリスクが高くなります。
研究者らは、Reach、Effectiveness、Adaption、Implementation、Maintenance (RE-AIM) と Proctor et al. を使用します。実装を比較するためのフレームワークと混合メソッドの比較中断時系列 (CITS) 設計。実装の推進要因と結果。実装の有効性。 GlobalConsent を実現するための、低強度と高強度 (LIS、HIS) の導入戦略の費用対効果。
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Kathryn Yount, PhD
- 電話番号:404-727-8511
- メール:kathryn.yount@emory.edu
研究場所
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Can Tho、ベトナム
- 募集
- Can Tho University of Medicine and Pharmacy (CTUMP)
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Da Nang、ベトナム
- 募集
- Da Nang University of Medical Technology & Pharmacy (DUMTP)
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Haiphong、ベトナム
- 募集
- Hai Phong University of Medicine and Pharmacy
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Hanoi、ベトナム、116001
- 募集
- Hanoi Medical University
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コンタクト:
- Tran Hung Minh, MD, MSc
- 電話番号:0243 5770261
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Ho Chi Minh City、ベトナム
- 募集
- Ho Chi Minh City Medicine and Pharmacy University
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Ho Chi Minh City、ベトナム
- 募集
- Hong Bang University
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Huế、ベトナム、470000
- 募集
- Hue University of Medicine and Pharmacy
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
学生の参加基準:
- 18~24歳、
- 異性愛者または両性愛者(女性に惹かれる)を自認する男性、
- ベトナム北部、中部、南部の6つの参加学習大学のいずれかに1年生として入学していること。
学生の除外基準:
- 大人が同意できない
- まだ成人していない人(幼児、児童、青少年)
教員の選択基準:
- 参加する 6 つの研究大学のすべての登録講師は、1 年目、3 年目、5 年目に気候調査に参加する資格があります。
教員の除外基準:
- なし
リーダーの参加基準:
- 各参加研究大学の研究スタッフの推薦
- GlobalConsent の実装環境と実装に関する知識。
リーダーの除外基準:
- なし
実装チームの参加基準:
- 関連する研究スタッフによって特定されました。
実装チームの除外基準:
- なし
研究計画
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:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
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実験的:学生
いずれかのランダム化グループの学生は、プログラム、プロセス、配信スケジュール、データ収集手順、および同意について電子メールで紹介され、GlobalConsent の積極的な利用者になります。
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LIS グループの学生は、米国の大学でオンライン プログラムを提供するためによく使用される GlobalConsent の基本的な実装戦略を、電子メール/SMS による完了リマインダーとともに、あらかじめ決められた頻度で 12 週間受け取ります。
他の名前:
Students in the HIS group will receive educational outreach in a pre-implementation orientation to GlobalConsent, covering similar topics and three monthly one-hour learning sessions during implementation in which technical questions about program access or progression can be addressed; more intensive intervention to enhance adherence with more frequent email/Short Message Service (SMS), completion reminders; and demand generation encouraging program completion.
他の名前:
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実験的:学部
教員は、大学のランダム化実施戦略グループに基づいて教育資料にアクセスできます。
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他の名前:
Web ベースの教材への受動的アクセス
他の名前:
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実験的:リーダー
リーダーは、実施戦略グループに基づいて、サイト固有(大学)の招待状と資料を受け取ります。
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他の名前:
他の名前:
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実験的:実装チームのメンバー
実装チームのメンバーは、大学固有の実装戦略グループに従って、Web ベースの資料とトレーニングに受動的にアクセスできます。
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他の名前:
他の名前:
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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 |
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Students' Reported Prosocial Bystander Behavior
時間枠:Baseline (month 10), every 6 months up to 30 months
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Students will be asked if they had engaged in any of seven prosocial bystander behaviors in the past 3 months (or since the last time completing the questionnaire).
Items are scored as 0 = never performed, 1 = performed once, 2 = performed more than once.
The numbers of participants who report engaging in at least one of seven prosocial bystander behaviors at least once are presented here.
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Baseline (month 10), every 6 months up to 30 months
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Students' reported Sexually Violent Behavior
時間枠:Baseline (month 10), every 6 months up to 30 months
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The Sexual Experiences Survey (SES) is an assessment tool used to measure the prevalence of sexual aggression.
It is designed to measure the frequency and severity of sexual aggression acts committed by an individual.
The SES is a self-report questionnaire developed by researchers at the University of Michigan.
The Sexual Experiences Survey - Short Form Victimization is a multi-item measure to assess unwanted sexual victimization.
Surveys will be provided every six months for up to 30 months.
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Baseline (month 10), every 6 months up to 30 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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障害の評価とスケジュール
時間枠:ベースライン
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学生のみ: 障害評価は、世界保健機関障害評価スケジュール 2.0 (WHODAS 2.0) を使用して評価されます。これは、精神障害、神経障害、依存性障害を含むすべての疾患にわたって使用される健康と障害の汎用評価手段であり、両方の疾患に適用されます。臨床および一般集団の設定。 これは、障害のレベルと機能を 6 つの領域で測定するツールです。 回答では、各質問を 0 (なし) から 4 (極端またはできない) のスケールで評価します。 採点方法には、単純スコア、複合スコア、平均スコアの 3 つがあります。 単純なスコアは、各質問の評価の合計です。 複合スコアは、評価の合計に重み係数を掛けたものです。 平均スコアは、各ドメインの評価の平均です。 |
ベースライン
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診断および統計マニュアル (DSM)-5 横断的な症状の対策
時間枠:ベースライン
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学生のみ: DSM-5 自己評価レベル 1 の横断的症状測定 - 成人向けは、さまざまな精神医学的診断にわたって重要なメンタルヘルス領域を評価するために設計されたツールです。
これは、うつ病、不安、身体症状など、13 の精神医学的領域を評価する 23 の質問で構成されています。
測定の各項目は 5 段階評価で評価されます (0= なしまたは全くなし、1= 軽度または稀、1 ~ 2 日未満、2= 軽度または数日、3= 中程度または半分以上)日; 4 = ひどい、またはほぼ毎日)。
ドメイン内の項目に対する軽度 (つまり 2) 以上の評価は、そのドメインのより詳細な評価が必要かどうかを判断するための追加の調査とフォローアップにつながる可能性があります。
特定の領域で一貫して高いスコアは、その個人にとって重大で問題のある症状を示している可能性があり、さらなる評価、治療、追跡調査が必要になる可能性があります。
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ベースライン
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アルコール障害の知識/認知に対するアルコールの影響
時間枠:ベースライン、6か月ごとに最大30か月。
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学生のみ:このフォームは、意思決定、行動、性的暴力に焦点を当てた5つのアルコール関連の質問について回答者の同意または意見の相違を求めます。
「完全に同意しない」から「完全に同意する」までの5ポイントのリッカートを使用して、合意または意見の相違を評価します。
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ベースライン、6か月ごとに最大30か月。
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Perceptions of Sexual Violence form at their respective university
時間枠:Baseline (month 10) and up to 49 months
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Perceptions of sexual violence will be assessed by respondents' rating their level of agreement with 3 statements regarding the frequency and impact of sexual violence at their university using a 5-point Likert scale ranging from "Totally disagree" to "Totally agree." Surveys will be provided to all groups at different time points as follows:
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Baseline (month 10) and up to 49 months
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Implementation Team Scale for staff and supervisors
時間枠:Baseline, month 25, month 29, and month 32
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Leadership in implementation teams is assessed using two scales, one for implementation team supervisors, and one for implementation team staff.
Each scale has 13 items and uses a 5-point Likert ranging from "Totally disagree" to "Totally agree" to assess respondent's agreement on statements about their team supervisor (for staff) or themselves (for supervisors).
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Baseline, month 25, month 29, and month 32
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Cultural Exchange Inventory
時間枠:Baseline, month 25, month 29, and month 32
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For implementation team members only: The Cultural Exchange Inventory assesses the teamwork landscape of GlobalConsent implementation teams using 7 items.
Respondents give their level of agreement, using a 5-point Likert scale ranging from "Totally disagree" to "Totally agree," on statements such as "The implementation team is working well together to implement GlobalConsent" and "My colleagues are devoting a lot of time and energy to maintain the collaboration of the implementation team.
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Baseline, month 25, month 29, and month 32
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College Date Rape Attitudes & Behaviors Scale
時間枠:Baseline, month 25, month 29, and month 32
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For implementation team members only: The College Date Rape Attitude Survey (CDRAS), a measure intended to assess attitudes related to the risk of committing rape in adolescents and young adults, the CDRAS measures four rape-related attitudes: Entitlement, Blame Shifting, Traditional Roles, and Overwhelming Sexual Arousal.
The CDRAS contains 20 items measuring attitudes toward date rape.
All items require responses on a 5-point Likert scale.
The responses for the attitude scale are strongly agree, agree, neutral, disagree, and strongly disagree.
Scoring is reversed for appropriate items; so that high scores (5) always correspond to the most desirable (rape-related) responses.
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Baseline, month 25, month 29, and month 32
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Acceptability, Feasibility, and Appropriateness of Programming to Prevent Sexually Violent Behavior among Students
時間枠:Baseline and up to 49 months
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This scale assesses respondents' attitudes towards sexual violence prevention programming by asking them to rate their level of agreement with 10 statements, such as "Implementing sexual violence prevention programming with students at our university is something I support," "...addresses a relevant problem among our students," "…would be easy for students to participate in." These statements will be rated using a 5-point Likert scale ranging from "Totally disagree" to "Totally agree." Surveys will be provided to all groups at different time points as follows:
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Baseline and up to 49 months
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Acceptability, Feasibility, and Appropriateness of GlobalConsent
時間枠:Baseline and up to 49 months
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This scale assesses respondents' attitudes towards the GlobalConsent program specifically by asking them to rate their level of agreement or disagreement with 10 statements, such as "Implementing GlobalConsent with students at our university is something I support," "...addresses a relevant problem among our students," "…would be easy for students to participate in." these statements will be rated using a 5-point Likert ranging from "Totally disagree" to "Totally agree." Surveys will be provided to all groups at different time points as follows:
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Baseline and up to 49 months
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Sexual Violence Legality and Harm (Information about Sexual Activity)
時間枠:Baseline and up to 49 months
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Knowledge of the law is assessed with 12 items where respondents indicate if they think the situations described are illegal (scored as 1), legal, but harmful (2), or legal and not harmful (3), with example items including "Forcing a person to have oral sex" and "Pressuring someone to have sex." Items will be re-coded such that responses indicating an accurate estimate or overestimate of the illegality and harms of sexual violence were coded as "1" and items indicating an underestimation of the illegality and harms of sexual violence were coded as "0". Surveys will be provided to all groups at different time points as follows:
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Baseline and up to 49 months
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Active Consent (Information about Sexual Consent)
時間枠:Baseline and up to 49 months
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This form adapted the Sexual Consent Scale to ask respondents to rate their level of agreement with 12 statements about sexual consent using a 5-point Likert scale ranging from "totally disagree" to "totally agree". It includes statements such as "If a person consents to sex, one can continue sexual contact even if the person changes their mind," and "Obtaining consent for sex is just as necessary in a long-term relationship as in a new relationship." Surveys will be provided to all groups at different time points as follows:
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Baseline and up to 49 months
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Rejection of Rape Myths (Attitudes about Sexual Situations)
時間枠:Baseline and up to 49 months
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This form is a combination of the Illinois Rape Myth Acceptance Scale and the College Date Rape Attitudes & Behaviors Scale. This assesses attitudes towards sexual assault and rape by asking respondents to rate their level of agreement or disagreement with 15 statements using a 5-point Likert scale ranging from "totally disagree" to "totally agree". Statements include "If a woman dresses in a sexy dress, she is asking for sex," and "When guys rape, it is usually because of their strong desire for sex." Surveys will be provided to all groups at different time points as follows:
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Baseline and up to 49 months
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Perceptions of Campus Attitudes
時間枠:Baseline and up to 49 months
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This form assesses the perceptions of respondents in their university's faculty and leaders' potential response to sexual violence on their university campus. Questions ask about behaviors of abuse, sexual assault, and stalking, and their level of agreement or disagreement with whether faculty and leaders would believe a student reporting experiencing these behaviors, respect a student who reported experiencing these behaviors, or admire a student intervening in these behaviors. Agreement is assessed using a 5-point Likert scale ranging from "totally disagree" to "totally agree" Surveys will be provided to all groups at different time points as follows:
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Baseline and up to 49 months
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Empathy for Rape Victims
時間枠:Baseline (month 10), every 6 months for up to 30 months.
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Students only: Empathy for rape victims will be assessed with a modified version of the Rape Empathy Scale (RES).
This assessment includes 10 items where participants were asked to choose between two statements, one of which reflected greater empathy towards rapists ("I understand the helplessness a rapist might feel during a rape since he cannot control his actions") and one of which reflected greater empathy towards victims ("I understand the helplessness a victim might feel during a rape").
Responses are scored as 1 (more empathy for victim) or 0 (more empathy for perpetrator) and total scores range from 0 to 10 where higher scores indicate more empathy towards rape victims.
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Baseline (month 10), every 6 months for up to 30 months.
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Sexual Communication Attitudes
時間枠:Baseline (month10), every 6 months for up to 30 months.
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Students only: This is a 7-item scale measuring agreement or disagreement with statements focusing on sexual communication.
Agreement and disagreement is assessed using a 5-point Likert ranging from "totally disagree" to "totally agree."
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Baseline (month10), every 6 months for up to 30 months.
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Bystander Self-Efficacy
時間枠:Baseline (month 10), every 6 months for up to 30 months.
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Students only: Bystander Self-Efficacy will be measured using the Bystander Efficacy Scale, which was developed for a project that evaluated the effectiveness of a sexual violence prevention program based on preventing antecedents to sexual violence by increasing prosocial bystander behavior.
On this measure, participants are asked to indicate their confidence, on a 3-point scale, in performing each of 10 bystander behaviors (e.g., "Speak up to a guy who is making excuses for using physical force in a sexual relationship.").
Scores are created by subtracting the mean of the 10 items from 100 to create a scale of perceived ineffectiveness; thus, higher scores indicate lesser effectiveness.
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Baseline (month 10), every 6 months for up to 30 months.
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Bystander Intention to Intervene (Readiness to Intervene)
時間枠:Baseline (month 10), every 6 months for up to 30 months.
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Students only: Readiness to Intervene will be measured using three intent-to-help subscales.
The second Intent to Help subscale focuses on participants' intent to help strangers in both sexual abuse and intimate partner abuse situations. Responses range from 1 (not at all likely) to 5 (extremely likely). The average is calculated from the answers across the items to score this measure. |
Baseline (month 10), every 6 months for up to 30 months.
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Severity Measure for Depression
時間枠:Baseline (month 10), every 6 months for up to 30 months.
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Students only: Depression will be measured using the Patient Health Questionnaire 9 (PHQ-9): The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring, and measuring the severity of depression.
The PHQ-9 is completed by the participant in minutes and is rapidly scored by a clinician.
The PHQ-9 can also be administered repeatedly, which can reflect the improvement or the worsening of depression in response to treatment.
PHQ-9 scores of 5, 10, 15, and 20 represent mild, moderate, moderately severe, and severe depression.
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Baseline (month 10), every 6 months for up to 30 months.
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Generalized Anxiety Disorder
時間枠:Baseline (month 10), every 6 months for up to 30 months.
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Students will complete the Generalized Anxiety Disorder 7-item (GAD-7), which is a quick and easy tool to help identify patients with anxiety and monitor treatment response. The GAD-7 has been validated as a diagnostic tool and a severity assessment scale. The scale consists of 7 items. The total score can range from 0 to 21, and it indicates the severity of anxiety as follows: 0 to 4: Minimal anxiety 5 to 9: Mild anxiety 10 to 14: Moderate anxiety 15 to 21: Severe anxiety |
Baseline (month 10), every 6 months for up to 30 months.
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Students' Proactive Bystander Behavior Scale
時間枠:Baseline (month 10), every 6 months up to 30 months
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This scale asks respondents to indicate whether and how often they completed proactive bystander behavior actions in the last 6 months (the time between each survey wave).
Behaviors include "I have encouraged others to learn more and get involved in preventing sexual or dating violence," and "I have told guys not to talk about women in sexually degrading ways," and response options for each statement are (0) No, I have not done this in the last 6 months, (1) Yes, once in the last 6 months, and (2) Yes, more than once in the last 6 months.
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Baseline (month 10), every 6 months up to 30 months
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Students' Reactive Bystander Action Scale
時間枠:Baseline (month 10), every 6 months up to 30 months
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This scale asks respondents whether and how often they completed reactive bystander behavior actions in the last 6 months (the time between each survey wave).
Actions include "I have expressed concern or offered help to a woman who said she had an unwanted sexual experience but didn't call it 'rape'," "I have reported formally to an authority a guy who used physical force against a women," and "I have intervened with a guy's action because I wanted to stop an act of sexual violence."
Responses options for each statement are (0) I experienced this situation in the last 6 months and did NOT act, (1) Yes, once in the last 6 months, (2) Yes, more than once in the last 6 months, and (9) I did NOT experience any situation like this in the last 6 months.
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Baseline (month 10), every 6 months up to 30 months
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者:Kathryn Yount, PhD、Emory University
出版物と役立つリンク
一般刊行物
- Yount KM, Whitaker D, Fang X, Trang QT, Macaulay M, Hung MT. Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): Study Protocol for a National Implementation Trial. Res Sq [Preprint]. 2024 Sep 10:rs.3.rs-4745916. doi: 10.21203/rs.3.rs-4745916/v1.
- Yount KM, Whitaker DJ, Fang X, Trang QT, Macaulay M, Minh TH. Strategies for Implementing GlobalConsent to Prevent Sexual Violence in University Men (SCALE): study protocol for a national implementation trial. Trials. 2024 Aug 29;25(1):571. doi: 10.1186/s13063-024-08401-5.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- STUDY00006481
- 1R01MH133259 (米国 NIH グラント/契約)
- 2025P011593 (その他の識別子:Emory Insight Humans IRB)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- ANALYTIC_CODE
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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。