A Pilot Efficacy and Implementation Study of the Strengths Intervention Project (SIP)
2019年10月14日 更新者：Children's Hospital of Philadelphia
The purpose of this study is to test a strengths-based intervention to be delivered in a primary care setting with adolescents and a parent.
Investigators want to find out if the intervention can help parents and teens communicate.
Specifically Investigators want to see if they can help parents and teens identify and build teen's strengths.
Half the dyads will receive the educational materials in conjunction with their teen's well-child visit, while the other half will receive usual care at the well-child visit and receive the educational materials at the end of the study.
Additionally, Investigators expect that a strengths-based intervention may also impact adherence to treatment in youth with a chronic illness.
As such, Investigators will include a subgroup of teenagers diagnosed with asthma in this study, to assess whether the strengths-based intervention that the Investigators developed has an impact on adherence.
調査の概要
詳細な説明
Recent research suggests that parents and adolescents report an interest in doctors facilitating increased parent-teen communication about teen strengths. However, little research focuses on how to address this need in a primary care setting. Content from subject matter experts along with data gathered from parents and teens were used to develop a novel strengths-based intervention to be tested in primary care.
The study intervention being examined is called the Strengths Intervention Project and includes a written pamphlet, a guided discussion activity, in-person/phone health coaching, and in-person or mailed health care provider endorsement and key messaging. Measures will be collected at baseline pre-intervention (T1), in clinic or over the phone at the time of the intervention (T2), approximately two weeks post-intervention (T3), and approximately 2 months post-intervention (T4). Daily diaries will also be utilized twice to gather data pre- and post- intervention. We will measure feasibility of clinic implementation of intervention, as well as influence of intervention on parent-teen communication and adolescent outcomes.
研究の種類
介入
入学 (実際)
174
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
-
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Pennsylvania
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Philadelphia、Pennsylvania、アメリカ、19104
- The Children's Hospital of Philadelphia
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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
13年～15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
Adolescent Criteria:
Inclusion Criteria:
- Teens age 13 to 15 years at the time of their upcoming well-child visit (Arm 1) OR Teens age 13 to 15 years at the time of their last well-child visit (Arm 2)
- Children's Hospital of Philadelphia (CHOP) primary care patient (Arm 1 and 2)
- Scheduled for a well-child visit that parent and teen both plan to attend (Arm 1) OR Attended a well-child visit with parent (Arm 2)
- Diagnosed with Asthma > year (asthma subgroup; Arm 1 only)
- Prescribed a controller medication year-round (asthma subgroup; Arm 1 only)
- Adolescent has their own email account to complete electronic surveys (Arm 1 and 2)
Exclusion Criteria:
- Not fluent in written or spoken English (Arm 1 and 2)
- Attending a new patient well-child visit (Arm 1) OR attended a new patient well-child visit (Arm 2)
- Presence of developmental delay or pervasive developmental disorder that requires special education services (Arm 1 and 2)
- Psychiatric hospitalization of the adolescent in the past year (Arm 1 and 2)
- Participated in studies: CHOP IRB # 15-011732 and/or CHOP IRB # 17-013895 (Arm 1 and 2)
- Adolescent has sibling enrolled in (IRB 18-014922) (Arm 1 and 2)
Parent Criteria:
Inclusion Criteria:
- Parent or legal guardian of a teen age 13 to 15 years at their upcoming well-child visit at a CHOP primary care practice (Arm 1) OR Parent or legal guardian of a teen age 13 to 15 years at their recent well-child visit at a CHOP primary care practice (Arm 2)
- Parent has their own email account to complete electronic surveys (Arm 1 and 2)
Exclusion Criteria:
- Not fluent in written or spoken English (Arm 1 and 2)
- Participated in studies: CHOP IRB # 15-011732 and/or CHOP IRB # 17-013895 (Arm 1 and 2)
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：他の
- 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 |
|---|---|
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実験的：Intervention Group (Arm 1- Main)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
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This is a clinic based psychoeducational intervention for adolescent patients and their parents to improve parent-teen communication about teen strengths.
The intervention is designed, if possible, to coincide with the adolescent patients' well-child visits and consists of the following components: (1) In-person or over the phone orientation session with a trained health coach and parent, (2) Distribution of psychoeducational materials to the parent, (3) Endorsement and delivery of key messages from the health care provider, and (4) "Booster" phone call placed by the health coach.
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介入なし：Control Group (Arm 1- Main)
Will receive usual care at well-child visit.
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実験的：Intervention Group (Arm 1-asthma subgroup)
Will receive the "Build Your Teen's Strengths" educational pamphlet, health coaching sessions, and provider endorsement.
|
This is a clinic based psychoeducational intervention for adolescent patients and their parents to improve parent-teen communication about teen strengths.
The intervention is designed, if possible, to coincide with the adolescent patients' well-child visits and consists of the following components: (1) In-person or over the phone orientation session with a trained health coach and parent, (2) Distribution of psychoeducational materials to the parent, (3) Endorsement and delivery of key messages from the health care provider, and (4) "Booster" phone call placed by the health coach.
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介入なし：Control Group (Arm 1-asthma subgroup)
Will receive usual care at well-child visit.
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介入なし：Control Group (Arm 2)
Convenience sample used for a post-hoc, exploratory analysis.
Will receive usual care at well-child visit.
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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 |
|---|---|---|
|
Change in Beliefs about Adolescents
時間枠：Baseline (T1) and 2-months (T4)
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26 items (parents only); Likert scale (1= very unlikely; 7= very, very likely)
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Baseline (T1) and 2-months (T4)
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Change in Parent-Adolescent Communication (PACS)
時間枠：Baseline (T1) and 2-months (T4)
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20 items (parent and teens); Likert scale (1= strongly disagree; 5= strongly agree)
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Baseline (T1) and 2-months (T4)
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Change in Confidence in exploring and using adolescent's strengths
時間枠：Baseline (T1) and 2-months (T4)
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15 items (parents and teens); Likert scale (1=strongly disagree; 5= strongly agree)
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Baseline (T1) and 2-months (T4)
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Feasibility of consent rates
時間枠：9 months
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Feasibility will be demonstrated by consent rates ≥60%
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9 months
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Feasibility of intervention implementation
時間枠：1 month
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Completion of core intervention components ≥ 70%.
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1 month
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Parent and adolescent acceptability of intervention materials
時間枠：2-weeks post intervention (T3)
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Adolescent and parent acceptability ratings ≥80%.
Investigators will also elicit open-ended feedback.
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2-weeks post intervention (T3)
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Parent and adolescent acceptability of intervention materials (additional)
時間枠：2-months post intervention (T4)
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2 items (parents and teens); Yes/No/Not sure and Likert scale (1=very likely; 5 very unlikely)
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2-months post intervention (T4)
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Provider acceptability of intervention
時間枠：9 months
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Provider acceptability ratings ≥80%.
Investigators will also elicit open-ended feedback.
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9 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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Change in Psychological well-being using the Flourishing Scale
時間枠：Baseline (T1) and 2-months (T4)
|
Measure of psychological well-being.
8 items (parents and teens).
(Likert scale 1= Strongly disagree; 2= Disagree; 3= Slightly disagree; 4= Mixed or neither agree nor disagree; 5= Slightly agree; 6= Agree; 7= Strongly agree).
Score will be summed for range of 8 (Strong Disagreement with all items) to 56 (Strong Agreement with items).
High scores signify that respondents view themselves in positive terms in important areas of functioning.
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Baseline (T1) and 2-months (T4)
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Change in Adherence to inhaled controller medication use
時間枠：Baseline (T1) and 2-months (T4)
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2-items about adherence to inhaled controller medication use (parent and teen) will be assessed using the Visual analog scale (0-10).
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Baseline (T1) and 2-months (T4)
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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。
捜査官
- 主任研究者：Victoria A Miller, PhD、Children's Hospital of Phiadelphia
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。
一般刊行物
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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)
2018年5月4日
一次修了 (実際)
2019年5月31日
研究の完了 (実際)
2019年5月31日
試験登録日
最初に提出
2018年3月21日
QC基準を満たした最初の提出物
2018年4月11日
最初の投稿 (実際)
2018年4月12日
学習記録の更新
投稿された最後の更新 (実際)
2019年10月15日
QC基準を満たした最後の更新が送信されました
2019年10月14日
最終確認日
2019年10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
- 18-014922
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?
いいえ
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
いいえ
米国FDA規制機器製品の研究
いいえ
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