児童擁護センターにおけるチーム中心の実施
農村児童擁護センターにおける小児外傷性ストレスのケア プロセス モデルの実装: チームに焦点を当てた実装のパイロット テスト
Child Advocacy Centers (CACs) are well-positioned to identify children at risk for mental health problems and to facilitate access to evidence-based treatments. Implementation of standardized mental health screening and referral protocols may improve recognition of mental health needs and facilitate treatment engagement. Implementation strategies that improve teamwork may enhance implementation outcomes in team-based settings like CACs. In this study, CACs will implement the Care Process Model for Pediatric Traumatic Stress (CPM-PTS) and be randomized to either team-focused implementation or standard implementation. The study aims are to evaluate the feasibility of team-focused implementation and the effect of the CPM-PTS on caregiver understanding of mental health needs and intentions to initiate treatment.
調査の概要
詳細な説明
This study is a pilot cluster randomized controlled hybrid Type II effectiveness-implementation trial in 4 rural Child Advocacy Centers. All CACs will implement the Care Process Model for Pediatric Traumatic Stress (CPM-PTS), a mental health screening and referral protocol. CACs will be randomized to team-focused implementation (n = 2) or standard implementation (n = 2). The study is designed to evaluate the acceptability, appropriateness, and feasibility of team-focused implementation strategies. It will also test the effect of the CPM-PTS on caregiver understanding of mental health needs and intentions to initiate treatment. Mixed methods will be used to evaluate the feasibility of team-focused implementation, test the effect of team strategies on teamwork, and assess implementation outcomes. Administrative data collected anonymously from caregivers will be used to test the effectiveness of the CPM-PTS.
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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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15213
- University of Pittsburgh
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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:
- Individuals at least 18 years of age who are members of the multidisciplinary team at the participating CACs.
Exclusion Criteria:
- Under 18 years old.
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:ヘルスサービス研究
- 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:チーム中心の実装
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CACs randomized to the experimental condition (n = 2) will participate in team-focused implementation. They will receive team development interventions (e.g., goal-setting exercise, training in communication skills) integrated with standard CPM-PTS training and technical assistance strategies. |
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アクティブコンパレータ:標準実装
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CACs randomized to the comparison condition (n = 2) will receive standard training and technical assistance strategies to support CPM-PTS implementation. They will receive CPM-PTS materials (e.g., manual, REDCap surveys, referral protocols), an interactive training, and six months of technical assistance. |
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 |
|---|---|---|
|
Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure
時間枠:Month 6
|
Perceived acceptability of team-focused implementation will be assessed with items from the Acceptability of Intervention Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 6
|
|
Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure
時間枠:Month 12
|
Perceived acceptability of team-focused implementation will be assessed with items from the Acceptability of Intervention Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 12
|
|
Appropriateness of Team-focused Implementation Assessed by the Intervention Appropriateness Measure
時間枠:Month 6
|
Perceived appropriateness of team-focused implementation will be assessed with items from the Intervention Appropriateness Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 6
|
|
Appropriateness of Team-focused Implementation Assessed by the Intervention Appropriateness Measure
時間枠:Month 12
|
Perceived appropriateness of team-focused implementation will be assessed with items from the Intervention Appropriateness Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 12
|
|
Feasibility of Team-focused Implementation Assessed by the Feasibility of Intervention Measure
時間枠:Month 6
|
Perceived feasibility of team-focused implementation will be assessed with items from the Feasibility of Intervention Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 6
|
|
Feasibility of Team-focused Implementation Assessed by the Feasibility of Intervention Measure
時間枠:Month 12
|
Perceived feasibility of team-focused implementation will be assessed with items from the Feasibility of Intervention Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 12
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Team Functioning (Learning Behavior) From Baseline to 6-month Follow-up
時間枠:Baseline, month 6
|
Affective, behavioral, and cognitive processes and states will be assessed with survey items rated on Likert scales. Scores will be averaged; higher scores indicate more adaptive team functioning (range 1-7). Learning behavior was assessed with 3 items. |
Baseline, month 6
|
|
Change in Team Functioning (Learning Behavior) From Baseline to 12-month Follow-up
時間枠:Baseline, month 12
|
Affective, behavioral, and cognitive processes and states will be assessed with survey items rated on Likert scales. Scores will be averaged; higher scores indicate more adaptive team functioning (range 1-7). Learning behavior was assessed with 3 items. |
Baseline, month 12
|
|
Change in Team Performance From Baseline to 6- and 12-month Follow-up
時間枠:Baseline, month 6, month 12
|
The overall quality of work done by the team will be assessed with 4 items rated on a 5-point Likert scale. Scores will be averaged; higher scores indicate better performance (range 1-5). |
Baseline, month 6, month 12
|
|
CPM-PTS Acceptability Assessed by the Acceptability of Intervention Measure
時間枠:Month 6
|
Perceived acceptability of the CPM-PTS will be assessed with items from the Acceptability of Intervention Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 6
|
|
CPM-PTS Acceptability Assessed by the Acceptability of Intervention Measure
時間枠:Month 12
|
Perceived acceptability of the CPM-PTS will be assessed with items from the Acceptability of Intervention Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 12
|
|
CPM-PTS Appropriateness Assessed by the Intervention Appropriateness Measure
時間枠:Month 6
|
Perceived appropriateness of the CPM-PTS will be assessed with items from the Intervention Appropriateness Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 6
|
|
CPM-PTS Appropriateness Assessed by the Intervention Appropriateness Measure
時間枠:Month 12
|
Perceived appropriateness of the CPM-PTS will be assessed with items from the Intervention Appropriateness Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 12
|
|
CPM-PTS Feasibility Assessed by the Feasibility of Intervention Measure
時間枠:Month 6
|
Perceived feasibility of the CPM-PTS will be assessed with items from the Feasibility of Intervention Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 6
|
|
CPM-PTS Feasibility Assessed by the Feasibility of Intervention Measure
時間枠:Month 12
|
Perceived feasibility of the CPM-PTS will be assessed with items from the Feasibility of Intervention Measure. Each item is rated on a 1-5 Likert scale. Scores will be averaged; higher scores indicate more positive perceptions (range 1-5). |
Month 12
|
|
CPM-PTS Adoption
時間枠:From start of the study for up to 12 months after CPM-PTS implementation
|
Adoption will be indicated by the number of days from training to the first completed screening. |
From start of the study for up to 12 months after CPM-PTS implementation
|
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CPM-PTS Reach
時間枠:Monthly for 9 months after CPM-PTS implementation
|
Reach will be indicated by screening rates (i.e., completed screenings / eligible children) and calculated for monthly and quarterly periods (possible range 0-100%). Reported below are the average monthly screening rate over 9 months (all available data) and the average quarterly screening rate across 3 quarters (all available data). |
Monthly for 9 months after CPM-PTS implementation
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Caregiver Understanding of Mental Health Needs
時間枠:Collected immediately after CAC visit for all caregivers served during an 18 month period (beginning 6 months before CPM-PTS implementation and continuing for 12 months after implementation)
|
Caregivers will rate 1 item assessing their understanding of their child's mental health needs on a 4-point Likert scale (range 1-4) in an anonymous end of visit survey. |
Collected immediately after CAC visit for all caregivers served during an 18 month period (beginning 6 months before CPM-PTS implementation and continuing for 12 months after implementation)
|
|
Caregiver Intention to Initiate Mental Health Services
時間枠:Collected immediately after CAC visit for all caregivers served during an 18 month period (beginning 6 months before CPM-PTS implementation and continuing for 12 months after implementation)
|
Caregivers will rate 1 item assessing their intention to initiate mental health services for their child on a 5-point Likert scale (range 1-5) in an anonymous end of visit survey. |
Collected immediately after CAC visit for all caregivers served during an 18 month period (beginning 6 months before CPM-PTS implementation and continuing for 12 months after implementation)
|
協力者と研究者
スポンサー
捜査官
- 主任研究者:Elizabeth McGuier, PhD、University of Pittsburgh
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 (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 (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
- STUDY21010070
- K23MH123729 (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
Deidentified data will be available upon reasonable request as allowed by IRB regulations and after manuscripts reporting the main findings are accepted for publication.
IPD 共有時間枠
Data will be available after manuscripts reporting the main findings are accepted for publication.
IPD 共有アクセス基準
Contact the principal investigator to request access to the deidentified data.
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
- 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
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