- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT05679154
Implementace zaměřená na tým v centrech dětské advokacie
Implementace modelu procesu péče o dětský traumatický stres ve venkovských centrech dětské advokacie: Pilotní test implementace zaměřené na tým
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Pennsylvania
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Pittsburgh, Pennsylvania, Spojené státy, 15213
- University of Pittsburgh
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Implementace zaměřená na tým
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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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Aktivní komparátor: Standardní implementace
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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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure
Časové okno: Month 6
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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
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Acceptability of Team-focused Implementation Assessed by the Acceptability of Intervention Measure
Časové okno: Month 12
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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
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Appropriateness of Team-focused Implementation Assessed by the Intervention Appropriateness Measure
Časové okno: Month 6
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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
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Appropriateness of Team-focused Implementation Assessed by the Intervention Appropriateness Measure
Časové okno: Month 12
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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
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Feasibility of Team-focused Implementation Assessed by the Feasibility of Intervention Measure
Časové okno: Month 6
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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
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Feasibility of Team-focused Implementation Assessed by the Feasibility of Intervention Measure
Časové okno: Month 12
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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
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Change in Team Functioning (Learning Behavior) From Baseline to 6-month Follow-up
Časové okno: Baseline, month 6
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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
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Change in Team Functioning (Learning Behavior) From Baseline to 12-month Follow-up
Časové okno: Baseline, month 12
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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
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Change in Team Performance From Baseline to 6- and 12-month Follow-up
Časové okno: Baseline, month 6, month 12
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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
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CPM-PTS Acceptability Assessed by the Acceptability of Intervention Measure
Časové okno: Month 6
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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
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CPM-PTS Acceptability Assessed by the Acceptability of Intervention Measure
Časové okno: Month 12
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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
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CPM-PTS Appropriateness Assessed by the Intervention Appropriateness Measure
Časové okno: Month 6
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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
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CPM-PTS Appropriateness Assessed by the Intervention Appropriateness Measure
Časové okno: Month 12
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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
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CPM-PTS Feasibility Assessed by the Feasibility of Intervention Measure
Časové okno: Month 6
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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
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CPM-PTS Feasibility Assessed by the Feasibility of Intervention Measure
Časové okno: Month 12
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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
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CPM-PTS Adoption
Časové okno: From start of the study for up to 12 months after CPM-PTS implementation
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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
Časové okno: Monthly for 9 months after CPM-PTS implementation
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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
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Caregiver Understanding of Mental Health Needs
Časové okno: 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)
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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)
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Caregiver Intention to Initiate Mental Health Services
Časové okno: 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)
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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)
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Spolupracovníci a vyšetřovatelé
Sponzor
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Elizabeth McGuier, PhD, University of Pittsburgh
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- STUDY21010070
- K23MH123729 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Deidentified data will be available upon reasonable request as allowed by IRB regulations and after manuscripts reporting the main findings are accepted for publication.
Časový rámec sdílení IPD
Data will be available after manuscripts reporting the main findings are accepted for publication.
Kritéria přístupu pro sdílení IPD
Contact the principal investigator to request access to the deidentified data.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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