PRIDE: Preventing Respiratory Illnesses During Childhood Study (PRIDE)
A+ Head Start Intervention for Smoke Free Homes
調査の概要
状態
条件
詳細な説明
About 90% of nonsmoking people in the US are exposed to ETS. More than 50 chemicals identified in ETS have been found to cause cancer and exposure has been linked to heart disease in adults and SIDS, ear infections and numerous respiratory problems, including asthma in children. In 2007, the Environmental Protection Agency and the Office of Head Start-a national program that provides economically disadvantaged children services to enhance their social and cognitive development-announced a new initiative to promote smoke-free homes for children in Head Start programs. Because Head Start reaches high-risk, low-income preschool children, it offers a timely intervention for reducing children's exposure to ETS. Head Start also attempts to engage parents, which is an important component of reducing household ETS exposure among children. This study will determine the effectiveness of a home-delivered, motivational interviewing-based program in reducing ETS exposure and improving lung health among children who are enrolled in the Baltimore City Head Start program and whose households include a smoker.
Participation in this study will last 1 year. First, all participating families will be visited at home by a study staff person who will attach special filters that will track the amount of nicotine in the various rooms of the house. During this initial visit, the participating children will undergo weight and height measurements and saliva sampling. About a week later, the filters will be collected, a 2nd saliva samples will be taken and parents will be interviewed about their family and child's health. Families will then be randomly assigned to one of two groups. Both groups will received educational information about reducing tobacco smoke exposure. One group will also receive the home-delivered, motivational interviewing-based program aimed to reduce ETS. This program will consist of 2 home visits and 2 phone calls, both led by health counselor who will teach participants how to reduce their child's exposure to tobacco smoke. The home visits will occur during Weeks 1 & 2 and the phone calls will occur during Weeks 3 & 6. Follow-up visits for all participating families will occur at Months 3,6 and 12 and will involve repeat filter testing, saliva monitoring and interviews.
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
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Maryland
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Baltimore、Maryland、アメリカ、21206
- Johns Hopkins University
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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 enrolled in Baltimore City Head Start
- Smoker living in the home with child
Exclusion Criteria:
- No smoker in home with child
- Does not speak English
- Is enrolled in other respiratory research study
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:階乗代入
- 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 |
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実験的:Behavioral
Motivational Interviewing Intervention Plus Education Caregivers will receive a home-based motivational interviewing intervention for ETS reduction plus an educational program for ETS reduction. |
The intervention is designed to motivate caregivers to reduce a child's ETS exposure by establishing a complete home and car smoking ban and by considering smoking cessation.
Caregivers will receive 2 home visits & 2 telephone session, both with a health counselor.
Caregivers will be provided with feedback on air nicotine levels and child salivary cotinine levels.
The main target for the intervention will be the primary caregiver of the child because the primary caregiver is ultimately responsible for protecting the child from ETS exposure.
Any and all household members may participate in the intervention visits but are not required to do so.
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アクティブコンパレータ:Education Only
Caregivers will receive only educational program for ETS reduction.
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An Environmental Protection Agency-based educational program that will consist of information about reducing tobacco smoke exposure.
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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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Air Nicotine Levels
時間枠:Measured at Baseline, 3, 6 and 12 months
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Air nicotine levels were an indicator of child's exposure to environmental tobacco smoke (ETS)
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Measured at Baseline, 3, 6 and 12 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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ETS Reduction, as Measured by Child's Cotinine Levels
時間枠:Measured at Baseline, 3, 6 and 12 months
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Child salivary cotinine will be a measure to evaluate environmental tobacco smoke (ETS) reduction
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Measured at Baseline, 3, 6 and 12 months
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Respiratory Function of Child by Self Report of Parent
時間枠:Measured at Baseline, 3, 6, and 12 months
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Number of cold infections child experienced in previous 3 months, reported by caregiver
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Measured at Baseline, 3, 6, and 12 months
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Health Care Utilization by Child- Self Report From Parent/Caregiver
時間枠:Measured at baseline and 3, 6 and 12 months
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Parent caregiver reported urgent care visits, number of hospitalizations, and number of emergency department visits in the 12 months prior for child enrolled in study
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Measured at baseline and 3, 6 and 12 months
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Number of Participants Who Report Endorsing a Home Smoking Ban
時間枠:Measured at baseline, 3, 6 and 12 months
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Number of participants endorsing presence of home smoking ban
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Measured at baseline, 3, 6 and 12 months
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Cynthia S Rand, PhD、Johns Hopkins 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 (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
- 664
- R18HL092901-01 (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
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。