- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07679620
Disseminating Effective Sexual Health Programs in Schools Using iCHAMPSS
Přehled studie
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Belinda Hernandez, PhD, MPH
- Telefonní číslo: (210) 276-9009
- E-mail: Belinda.Hernandez@uth.tmc.edu
Studijní záloha kontaktů
- Jméno: Laura Thormaehlen
- Telefonní číslo: (713) 500-9000
- E-mail: Laura.C.Thormaehlen@uth.tmc.edu
Studijní místa
-
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Texas
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Houston, Texas, Spojené státy, 77030
- Nábor
- The University of Texas Health Science Center at Houston
-
Kontakt:
- Belinda Hernandez, PhD, MPH
- Telefonní číslo: (210) 276-9009
- E-mail: Belinda.Hernandez@uth.tmc.edu
-
Kontakt:
- Laura Thormaehlen
- Telefonní číslo: (713) 500-9000
- E-mail: Laura.C.Thormaehlen@uth.tmc.edu
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Licensed educator or administrator who holds one of the following positions: 1) district or school administrator (e.g., health coordinators, instructional specialists, and curriculum coordinators), 2) health and physical education teachers, and 3) social and health service staff (e.g., nurses and counselors) in a Texas school district participating in the iCHAMPSS 2.0 study
Exclusion Criteria:
- not holding a job in a Texas school district as a school stakeholder, OR holding a job in a Texas school district as a school stakeholder but not in a school district participating in the iCHAMPSS 2.0 study
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Crossover Assignment
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Arm 1: 1 semester of implementation then 7 semesters of intervention
|
iCHAMPSS 2.0 is designed for Program Champions, critical to EBP use, such as district and school administrators, SHAC members (which include parents), and health and physical education teachers, who are highly motivated to promote sexual health education. iCHAMPSS 2.0 has four features:
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Experimentální: Arm 2: 1 semester of control, 1 semester of implementation then 7 semesters of intervention
|
iCHAMPSS 2.0 is designed for Program Champions, critical to EBP use, such as district and school administrators, SHAC members (which include parents), and health and physical education teachers, who are highly motivated to promote sexual health education. iCHAMPSS 2.0 has four features:
|
|
Experimentální: Arm 3: 1 semesters of control, 1 semester of implementation then 6 semesters of intervention
|
iCHAMPSS 2.0 is designed for Program Champions, critical to EBP use, such as district and school administrators, SHAC members (which include parents), and health and physical education teachers, who are highly motivated to promote sexual health education. iCHAMPSS 2.0 has four features:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Change in percentage of schools within a district implementing an EBP
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Rate of implementation of the EBP
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of School Health Advisory Councils (SHACs) that have recommended a sexual health EBP to their school board
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
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Percentage of School Health Advisory Councils (SHACs) that have adopted a sexual health EBP to their school board
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
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Percentage of schools with the school board's approval of an Evidence Based Program (EBP)
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
|
Percentage of schools with the principal's approval of an EBP
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
|
Percentage of students receiving majority (over 50%) of a sexual health EBP
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
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Percentage of schools that have implemented the evidence-based program for more than one academic year as assessed by the implementation survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in perceived complexity as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 3 item questionnaire and each is scored form (1) Strongly disagree to (5) Strongly agree, maximum score of 15, higher score indicating worse outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in compatibility as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 5 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree maximum score 25, higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in relative advantage as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
This is a 4 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree, maximum score of 20, higher score indicating better better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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|
Change in perceived social systems support in parent community as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
This is a 8 item questionnaire and each is scored from (1) not at all supportive to (4) very supportive , maximum score of 32 , higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in presence of school policy as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 2 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 10, higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Change in adequate resources as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
This is a 5 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score of 25, higher score indicating better outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in presence of a program champion as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
This is a 4 item questionnaire and each is scored 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in implementation climate as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 6 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score of 30, higher score indicating better outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in inter organizational relationships as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
This is a 4 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in intra organizational relationships as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
This is a 4 item questionnaire and each is scored from 1(strongly disagree) -5(strongly agree), maximum score 20, higher score indicating better outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in perceived need as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
This is a 4 item questionnaire and each is scored from (1) Strongly disagree to (5) Strongly agree, maximum score range of 20, higher score indicating worse outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in self-efficacy as assessed by the staff survey
Časové okno: From baseline to end of intervention period (about 20 to 30 months from baseline)
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This is a 19 item questionnaire and each is scored from 1(not at all confident)-4(very confident) , maximum score range of 76, higher score indicating better outcome
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From baseline to end of intervention period (about 20 to 30 months from baseline)
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Frequency of use of iCHAMPSS 2.0 as assessed by the website analytics
Časové okno: From baseline to end of school year (about 7 to 12 months from baseline)
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From baseline to end of school year (about 7 to 12 months from baseline)
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Time spent using iCHAMPSS 2.0 as assessed by the district coordinator survey
Časové okno: From baseline to end of school year (about 7 to 12 months from baseline)
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This will be reported categorically as less than one hour, 1-2 hours, 3-4 hours, 5-6 hours and 7 hours or more
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From baseline to end of school year (about 7 to 12 months from baseline)
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Number of recurring users of iCHAMPSS 2.0 as assessed by the website analytics
Časové okno: From baseline to end of school year (about 7 to 12 months from baseline)
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From baseline to end of school year (about 7 to 12 months from baseline)
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|
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Number of unique users of iCHAMPSS 2.0 as assessed by the website analytics
Časové okno: From baseline to end of school year (about 7 to 12 months from baseline)
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From baseline to end of school year (about 7 to 12 months from baseline)
|
|
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Mean number of users per school district of iCHAMPSS 2.0 as assessed by the website analytics
Časové okno: From baseline to end of school year (about 7 to 12 months from baseline)
|
From baseline to end of school year (about 7 to 12 months from baseline)
|
|
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Percentage of school districts/schools using iCHAMPSS 2.0 as assessed by the website analytics
Časové okno: From baseline to end of school year (about 7 to 12 months from baseline)
|
From baseline to end of school year (about 7 to 12 months from baseline)
|
|
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Percentage of iCHAMPSS 2.0 tools used in each step as assessed by the website analytics
Časové okno: From baseline to end of school year (about 7 to 12 months from baseline)
|
From baseline to end of school year (about 7 to 12 months from baseline)
|
|
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Perceived barriers to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
Časové okno: From baseline to end of school year (about 7 to 12 months from baseline)
|
This will be reported as a percentage
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From baseline to end of school year (about 7 to 12 months from baseline)
|
|
Perceived facilitators to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
Časové okno: From baseline to end of school year (about 7 to 12 months from baseline)
|
This will be reported as a percentage
|
From baseline to end of school year (about 7 to 12 months from baseline)
|
Spolupracovníci a vyšetřovatelé
Spolupracovníci
Vyšetřovatelé
- Vrchní vyšetřovatel: Belinda Hernandez, PhD, MPH, The University of Texas Health Science Center, Houston
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
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
- HSC-SPH-24-0672
- R01HD111699 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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