- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT07679620
Disseminating Effective Sexual Health Programs in Schools Using iCHAMPSS
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Belinda Hernandez, PhD, MPH
- Telefoonnummer: (210) 276-9009
- E-mail: Belinda.Hernandez@uth.tmc.edu
Studie Contact Back-up
- Naam: Laura Thormaehlen
- Telefoonnummer: (713) 500-9000
- E-mail: Laura.C.Thormaehlen@uth.tmc.edu
Studie Locaties
-
-
Texas
-
Houston, Texas, Verenigde Staten, 77030
- Werving
- The University of Texas Health Science Center at Houston
-
Contact:
- Belinda Hernandez, PhD, MPH
- Telefoonnummer: (210) 276-9009
- E-mail: Belinda.Hernandez@uth.tmc.edu
-
Contact:
- Laura Thormaehlen
- Telefoonnummer: (713) 500-9000
- E-mail: Laura.C.Thormaehlen@uth.tmc.edu
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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:
|
|
Experimenteel: 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:
|
|
Experimenteel: 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:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
|---|---|
|
Change in percentage of schools within a district implementing an EBP
Tijdsspanne: 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
Tijdsspanne: 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)
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Percentage of School Health Advisory Councils (SHACs) that have recommended a sexual health EBP to their school board
Tijdsspanne: 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
Tijdsspanne: 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 school board's approval of an Evidence Based Program (EBP)
Tijdsspanne: 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
Tijdsspanne: 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 students receiving majority (over 50%) of a sexual health EBP
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in compatibility as assessed by the staff survey
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
|
From baseline to end of intervention period (about 20 to 30 months from baseline)
|
|
Change in presence of school policy as assessed by the staff survey
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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)
|
|
|
Time spent using iCHAMPSS 2.0 as assessed by the district coordinator survey
Tijdsspanne: From baseline to end of school year (about 7 to 12 months from baseline)
|
This will be reported categorically as less than one hour, 1-2 hours, 3-4 hours, 5-6 hours and 7 hours or more
|
From baseline to end of school year (about 7 to 12 months from baseline)
|
|
Number of recurring users of iCHAMPSS 2.0 as assessed by the website analytics
Tijdsspanne: 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)
|
|
|
Number of unique users of iCHAMPSS 2.0 as assessed by the website analytics
Tijdsspanne: 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)
|
|
|
Mean number of users per school district of iCHAMPSS 2.0 as assessed by the website analytics
Tijdsspanne: 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)
|
|
|
Percentage of school districts/schools using iCHAMPSS 2.0 as assessed by the website analytics
Tijdsspanne: 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)
|
|
|
Percentage of iCHAMPSS 2.0 tools used in each step as assessed by the website analytics
Tijdsspanne: 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)
|
|
|
Perceived barriers to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
Tijdsspanne: 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)
|
|
Perceived facilitators to implementing iCHAMPSS 2.0 as assessed by the coordinator interviews and district coordinator surveys
Tijdsspanne: 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)
|
Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Belinda Hernandez, PhD, MPH, The University of Texas Health Science Center, Houston
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- HSC-SPH-24-0672
- R01HD111699 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .