- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07679620
Disseminating Effective Sexual Health Programs in Schools Using iCHAMPSS
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Belinda Hernandez, PhD, MPH
- Numero di telefono: (210) 276-9009
- Email: Belinda.Hernandez@uth.tmc.edu
Backup dei contatti dello studio
- Nome: Laura Thormaehlen
- Numero di telefono: (713) 500-9000
- Email: Laura.C.Thormaehlen@uth.tmc.edu
Luoghi di studio
-
-
Texas
-
Houston, Texas, Stati Uniti, 77030
- Reclutamento
- The University of Texas Health Science Center at Houston
-
Contatto:
- Belinda Hernandez, PhD, MPH
- Numero di telefono: (210) 276-9009
- Email: Belinda.Hernandez@uth.tmc.edu
-
Contatto:
- Laura Thormaehlen
- Numero di telefono: (713) 500-9000
- Email: Laura.C.Thormaehlen@uth.tmc.edu
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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:
|
|
Sperimentale: 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:
|
|
Sperimentale: 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:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Change in percentage of schools within a district implementing an EBP
Lasso di tempo: 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
Lasso di tempo: 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)
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Percentage of School Health Advisory Councils (SHACs) that have recommended a sexual health EBP to their school board
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Belinda Hernandez, PhD, MPH, The University of Texas Health Science Center, Houston
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- HSC-SPH-24-0672
- R01HD111699 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Educazione alla Salute Sessuale
-
University of Dublin, Trinity CollegeSconosciutoBrain Health Atleti d'élite in pensione
-
Seattle Children's HospitalEunice Kennedy Shriver National Institute of Child Health and Human Development... e altri collaboratoriNon ancora reclutamentoUn intervento formativo sulla comunicazione vaccinale per i medici del reparto pediatrico (PIVOT-IN)Servizi Sanitari Preventivi (PREV HEALTH SERV)Stati Uniti
-
University of MacauReclutamentoAlfabetizzazione sanitaria | Alfabetizzazione Alimentare | Alfabetizzazione mediatica | E-Health AlfabetizzazioneMacao
-
University of Colorado, DenverEunice Kennedy Shriver National Institute of Child Health and Human Development... e altri collaboratoriCompletatoServizi Sanitari Preventivi (PREV HEALTH SERV)Stati Uniti
-
King's College LondonSouth London and Maudsley NHS Foundation TrustIscrizione su invitoDetenzione in base al Mental Health ActRegno Unito
-
The Hospital for Sick ChildrenBill and Melinda Gates Foundation; Aga Khan UniversityAttivo, non reclutanteUnder Five Child Health Nutrizione e immunizzazionePakistan
-
Queens College, The City University of New YorkReclutamentoPubblicazione di articoli sottoposti all'American Journal of Public HealthStati Uniti
-
KTO Karatay UniversityCompletatoComportamenti di stile di vita sani | E-Health AlfabetizzazioneTacchino
-
Kliniek ViaSanaSt. Anna Ziekenhuis, Geldrop, NetherlandsCompletatoDolore | Uso di oppioidi | Sostituzione totale del ginocchio | App E-healthOlanda
-
Brown UniversityJohns Hopkins University; University of Arkansas; Anhui Medical UniversityCompletato
Prove cliniche su iCHAMPSS 2.0
-
BrainQ Technologies Ltd.Completato
-
Aarhus University HospitalAttivo, non reclutanteDisplasia della rotulaDanimarca
-
Imperial College LondonNational Institute for Health Research, United KingdomCompletatoDisturbo della salute mentale | Problema di comportamento del bambino | Comportamento autolesionistico | Problema di comportamento adolescenzialeRegno Unito
-
Otivio ASIscrizione su invitoDolore | Sclerosi multipla | Spasticità, muscoloNorvegia
-
University of PittsburghThe Grable Foundation; Department Human Services, Pennsylvania; Fisa FoundationCompletatoViolenza, domestica | Abilità di coping | La violenza in adolescenza | Comportamento adolescenziale | Violenza, sessuale | Violenza, fisica | Violenza, non accidentale | Gruppo, Pari | Abuso emotivo | Comunicazione, personaleStati Uniti
-
Hospital Clinic of BarcelonaInstitut d'Investigacions Biomèdiques August Pi i Sunyer; Centro de Investigación... e altri collaboratoriSospesoAutomonitoraggio e psicoeducazione nei pazienti bipolari con un'applicazione per smartphone (SIMPLE)Disordine bipolareSpagna
-
NYU Langone HealthNational Institutes of Health (NIH); Alzheimer's Association; LiteCure LLCAttivo, non reclutanteMalattia di Alzheimer | Compromissione cognitiva lieveStati Uniti
-
Work Life HelpNational Institute on Aging (NIA)CompletatoDeprivazione psicosociale | Stress dovuto al lavoro | Squilibrio vita-lavoroStati Uniti
-
Northwestern UniversityOhio State UniversityAttivo, non reclutanteCalcolo renale | Pietra ureteraleStati Uniti
-
Military University Hospital, PragueReclutamentoIdrocefalo a pressione normaleCechia