- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07679620
Disseminating Effective Sexual Health Programs in Schools Using iCHAMPSS
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Belinda Hernandez, PhD, MPH
- Phone Number: (210) 276-9009
- Email: Belinda.Hernandez@uth.tmc.edu
Study Contact Backup
- Name: Laura Thormaehlen
- Phone Number: (713) 500-9000
- Email: Laura.C.Thormaehlen@uth.tmc.edu
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Recruiting
- The University of Texas Health Science Center At Houston
-
Contact:
- Belinda Hernandez, PhD, MPH
- Phone Number: (210) 276-9009
- Email: Belinda.Hernandez@uth.tmc.edu
-
Contact:
- Laura Thormaehlen
- Phone Number: (713) 500-9000
- Email: Laura.C.Thormaehlen@uth.tmc.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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:
|
|
Experimental: 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:
|
|
Experimental: 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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in percentage of schools within a district implementing an EBP
Time Frame: 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
Time Frame: 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)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of School Health Advisory Councils (SHACs) that have recommended a sexual health EBP to their school board
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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)
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Belinda Hernandez, PhD, MPH, The University of Texas Health Science Center, Houston
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HSC-SPH-24-0672
- R01HD111699 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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