- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07679620
Disseminating Effective Sexual Health Programs in Schools Using iCHAMPSS
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Belinda Hernandez, PhD, MPH
- Telefonnummer: (210) 276-9009
- E-post: Belinda.Hernandez@uth.tmc.edu
Studer Kontakt Backup
- Navn: Laura Thormaehlen
- Telefonnummer: (713) 500-9000
- E-post: Laura.C.Thormaehlen@uth.tmc.edu
Studiesteder
-
-
Texas
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Houston, Texas, Forente stater, 77030
- Rekruttering
- The University of Texas Health Science Center at Houston
-
Ta kontakt med:
- Belinda Hernandez, PhD, MPH
- Telefonnummer: (210) 276-9009
- E-post: Belinda.Hernandez@uth.tmc.edu
-
Ta kontakt med:
- Laura Thormaehlen
- Telefonnummer: (713) 500-9000
- E-post: Laura.C.Thormaehlen@uth.tmc.edu
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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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|
Eksperimentell: 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:
|
|
Eksperimentell: 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:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Change in percentage of schools within a district implementing an EBP
Tidsramme: 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)
|
|
Rate of implementation of the EBP
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Percentage of School Health Advisory Councils (SHACs) that have recommended a sexual health EBP to their school board
Tidsramme: 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)
|
|
|
Percentage of School Health Advisory Councils (SHACs) that have adopted a sexual health EBP to their school board
Tidsramme: 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)
Tidsramme: 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)
|
|
|
Percentage of schools with the principal's approval of an EBP
Tidsramme: 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
Tidsramme: 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)
|
|
|
Percentage of schools that have implemented the evidence-based program for more than one academic year as assessed by the implementation survey
Tidsramme: 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)
|
|
|
Change in perceived complexity as assessed by the staff survey
Tidsramme: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
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
Tidsramme: 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 to (5) Strongly agree maximum score 25, higher score indicating better outcome
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in relative advantage as assessed by the staff survey
Tidsramme: 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
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in perceived social systems support in parent community as assessed by the staff survey
Tidsramme: 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
Tidsramme: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
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
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in adequate resources as assessed by the staff survey
Tidsramme: 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
Tidsramme: 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
Tidsramme: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: From baseline to end of intervention period (about 20 to 30 months from baseline)
|
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
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Frequency of use of iCHAMPSS 2.0 as assessed by the website analytics
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Percentage of school districts/schools using iCHAMPSS 2.0 as assessed by the website analytics
Tidsramme: 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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Percentage of iCHAMPSS 2.0 tools used in each step as assessed by the website analytics
Tidsramme: 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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Perceived barriers to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
Tidsramme: From baseline to end of school year (about 7 to 12 months from baseline)
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This will be reported as a percentage
|
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
Tidsramme: 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)
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Belinda Hernandez, PhD, MPH, The University of Texas Health Science Center, Houston
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Andre studie-ID-numre
- HSC-SPH-24-0672
- R01HD111699 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
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