Unidos Against ATOD Use Intervention Trial (TWC)
Reducing Alcohol, Tobacco, and Drug Use Among Latino Immigrant Youth: A Preliminary Test of the ¡Unidos Se Puede! Program
Adolescent alcohol tobacco and drug (ATOD) use is a major public health concern, with rates for Latino middle school youth higher than other ethnic groups. One well-established precursor of adolescent ATOD use is psychosocial stress. The proposed project examines the preliminary efficacy of Unidos to decrease ATOD use among Latino youth in new settlement areas. The goals of this efficacy trial will be achieved by accomplishing two specific aims: (1) Evaluate the potential of the intervention to delay the initiation into or reduce ATOD use among Latino youth who are 1st to 2nd generation immigrants; and (2) Evaluate the intervention's ability to strengthen known protective factors against ATOD use among adolescents-specifically child personal agency and parent-child, peer, and school relationships.
The study's primary hypothesis is: The Unidos Se Puede program will delay initiation of ATOD use of current non-users and reduce use among current users.
調査の概要
詳細な説明
Adolescent alcohol tobacco and drug (ATOD) use is a major public health concern, with rates for Latino middle school youth higher than other ethnic groups. One well-established precursor of adolescent ATOD use is psychosocial stress. The overall aim of this project is to test the efficacy of a culturally appropriate psychosocial program to prevent or reduce ATOD use among Latino immigrant youth. The intervention consists of: (1) encouraging parental involvement in child schooling, general parenting skills, and coping strategies ; (2) fostering child social emotional learning (SEL) through assigning a near-peer success coach to help develop critical thinking, problem solving, and goal setting skills; and (3) promoting positive peer affiliations through participation in regular activities that facilitate bonding to prosocial institutions.
The specific aims are:
(1) Evaluate the potential of the intervention to delay the initiation into or reduce ATOD use among Latino youth who are 1st to 2nd generation immigrants; and (2) Evaluate the intervention's ability to strengthen known protective factors against ATOD use among adolescents-specifically child personal agency and parent-child, peer, and school relationships.
The study's primary hypothesis is: The Unidos Se Puede program will delay initiation of ATOD use of current non-users and reduce use among current users.
To accomplish these aims, we propose an attention placebo randomized control trial. For this trial, we will recruit a sample of youth and their parents (N=120 dyads) from a random sample of Latino 6th and 7th grade students in Tulsa Public Schools. Those meeting the inclusion/exclusion criteria and agreeing to participate will provide baseline data before being randomly assigned to either the treatment or control condition (n=60 dyads each). Participants will be followed for 12 months post-baseline, during which time we will collect psychosocial measures annually near the end of each school year (May to June). The study will collect psychosocial measures from parents and youth.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Ronald B Cox, PhD
- 電話番号：4057449938
- メール：r.cox@okstate.edu
研究連絡先のバックアップ
- 名前：Isaac Washburn, PhD
- 電話番号：4057443683
- メール：isaac.washburn@okstate.edu
研究場所
-
-
Oklahoma
-
Tulsa、Oklahoma、アメリカ、74106
- 募集
- Oklahoma State University-Tulsa
-
コンタクト：
- Isaac Washburn, PhD
- 電話番号：4057443683
- メール：isaac.washburn@okstate.edu
-
コンタクト：
- Ronald B Cox, PhD
- 電話番号：405-744-9938
- メール：r.cox@okstate.edu
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Self-identified as Latino (Hispanic),
- Spanish as the primary language spoken in home,
- Enrolled in 6th or 7th grade in public school at one of the target sites.
Exclusion Criteria:
- Currently undergoing mental health treatment,
- Not eligible to take end of year examinations due to cognitive limitations.
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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Unidos Se Puede
Unidos Se Puede: consists of 5-weekly Family Workshops, 6 monthly booster sessions, 10-months success coaching, adolescent group activities and will be compared to an attention placebo control.
|
The intervention consists of: (1) encouraging parental involvement in child schooling, general parenting skills, and coping strategies ; (2) fostering child social emotional learning (SEL) through assigning a near-peer success coach to help develop critical thinking, problem solving, and goal setting skills; and (3) promoting positive peer affiliations through participation in regular activities that facilitate bonding to prosocial institutions.
他の名前：
|
|
プラセボコンパレーター：Attention placebo control
Placebo consists of after school club for youth.
|
The intervention consists of: (1) encouraging parental involvement in child schooling, general parenting skills, and coping strategies ; (2) fostering child social emotional learning (SEL) through assigning a near-peer success coach to help develop critical thinking, problem solving, and goal setting skills; and (3) promoting positive peer affiliations through participation in regular activities that facilitate bonding to prosocial institutions.
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 |
|---|---|---|
|
Change in past 30-day ATOD use (alcohol, tobacco, marijuana)
時間枠：Baseline and 12 months post-baseline
|
The ATOD outcome measure creates a single index of use by summing youth report of the frequency of their use during the past 30 days for each of the following substance: alcohol, tobacco and marijuana.
|
Baseline and 12 months post-baseline
|
協力者と研究者
捜査官
- 主任研究者：Ronald B Cox, PhD、Oklahoma State University
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
その他の研究ID番号
- IRB-21-290
- 5P20GM109097-02 (米国 NIH グラント/契約)
- 1R15DA049232-01 (米国 NIH グラント/契約)
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
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
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。
Unidos Se Puedeの臨床試験
-
Fatebenefratelli HospitalFederico II University; Federal University of Rio Grande do Sul; Royal Brompton & Harefield NHS... と他の協力者募集冠動脈疾患 | 心不全 | 大動脈弁疾患 | 肺動脈高血圧 | ファロー四徴症 | 肥大型心筋症 | アスリートハートイタリア
-
University of California, San Francisco完了
-
Boston VA Research Institute, Inc.Agency for Healthcare Research and Quality (AHRQ)完了
-
Boehringer Ingelheim完了
-
Indiana UniversityMayo Clinic; University of British Columbia; Ohio State University; Boston Scientific Corporation完了
-
IDRIBill and Melinda Gates Foundation完了
-
Anne Birgitte RabenUniversity of Leeds; Wageningen University; University of Liverpool; Maastricht University; Harokopio... と他の協力者完了
-
Abbott Medical Devices完了