The Impact of a Tobacco Control Intervention in African-American Families
The purpose of this randomized control trial is to evaluate the effects of a multi-component intervention aimed at:
- preventing tobacco initiation in youth
- promoting anti-tobacco socialization in the home
- decreasing environmental tobacco smoke exposure in children
- promoting successful cessation in parent/guardian smokers.
Control arm participants receive general health education. This family-based approach is implemented with school systems as the primary point of entry.
調査の概要
状態
条件
詳細な説明
All research participants (children and parents/guardians) will be recruited from 14 schools (7 control and 7 intervention; 7 urban and 7 rural) in a Southeastern U.S.
Self-report measures are at: baseline, end of year one, year 2, end of year two, and years three and four. Biological measures of salivary cotinine are at Baseline, end of treatment (year 2) and end of study (year 4).
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
Georgia
-
Augusta、Georgia、アメリカ、30912
- Georgia Health Sciences University
-
-
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:
- child being of African-American ethnicity
- in a 4th grade classroom of randomized schools
- parent or guardian that 4th grade child resides with at least 50% of the time
- have access to a telephone or mobile phone
Exclusion Criteria:
- not being a child of African-American ethnicity
- not being a parent or guardian that an eligible child lives with at least 50% of the time
- not having access to a telephone or cell phone
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 |
|---|---|
|
実験的:LifeSkills training
|
LifeSkills Training (Botvin's) is an evidenced based substance abuse prevention program for elementary school students to learn skills to resist tobacco, alcohol, drug abuse, and violence. Parent LifeSkills will also be utilized. Parents are provided a parent manual and DVD to use at home with their child to reinforce what they are taught in school-based LifeSkills sessions.
他の名前:
For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.
他の名前:
|
|
アクティブコンパレータ:Healthy Lifestyle Behaviors
|
The healthy lifestyle behavior choices curriculum augments the state health curriculum in the assigned study schools. Parents will also be given health related information by mail to parallel the information students receive in school health classes.
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 |
|---|---|---|
|
Primary prevention of tobacco use in youth
時間枠:Baseline
|
Self-report and salivary cotinine is assessed to measure this outcome
|
Baseline
|
|
Primary prevention of tobacco use in youth
時間枠:Year 2
|
Self-report and salivary cotinine is assessed to measure this outcome.
|
Year 2
|
|
Primary prevention of tobacco use in youth
時間枠:Year 4
|
Self-report and salivary cotinine is assessed to measure this outcome.
|
Year 4
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
Smoking cessation in parents/guardians
時間枠:3 months
|
3 months
|
|
Smoking cessation in parents/guardians
時間枠:6 months
|
6 months
|
|
Smoking cessation in parents/guardians
時間枠:Year 1
|
Year 1
|
|
Smoking cessation in parents/guardians
時間枠:Year 2
|
Year 2
|
|
Smoking cessation in parents/guardians
時間枠:Year 4
|
Year 4
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Martha S Tingen, PhD、Augusta 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
一次修了 (実際)
研究の完了 (実際)
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 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
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
追加の関連 MeSH 用語
その他の研究ID番号
- R01CA118066 (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。