Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06574321
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Teen Talk High School Refresher Rigorous Evaluation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Rigorous Evaluation of the Teen Talk High School Refresher Interventions Impact on Pregnancy Prevention Among Rural California Adolescents
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TTHSR
Brief Summary:
Unintended pregnancy rates among teenagers are higher in rural counties than urban or suburban counties The Teen Talk High School Refresher TTHSR is a sexual health education booster program for older high school students attending school in rural communities that was designed to help address this health disparity Though there is preliminary evidence of the programs effectiveness it has not yet been rigorously evaluated with a randomized controlled trial
TTHSR is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they transition from high school into adulthood in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections Because the California Health Youth Act mandates it in public schools most students this age will have received prior SHE TTHSR is a 5-hour booster intervention delivered during late high school intended to enhance the effectiveness of previous SHE
The studys primary research question is
What is the impact at 6-months post baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex or used condoms or effective birth control when they had vaginal or anal sex in the past 90 days
The studys secondary research questions are
What is the impact at 6-months post baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers peers and partners about their sexual health and sexuality
What is the impact at 6-months post-baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services
What is the impact at 12-months post-baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex or used condoms or effective birth control when they had vaginal or anal sex in the past 90 days
TTHSR is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they transition from high school into adulthood in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections Because the California Health Youth Act mandates it in public schools most students this age will have received prior SHE TTHSR is a 5-hour booster intervention delivered during late high school intended to enhance the effectiveness of previous SHE
The studys primary research question is
What is the impact at 6-months post baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex or used condoms or effective birth control when they had vaginal or anal sex in the past 90 days
The studys secondary research questions are
What is the impact at 6-months post baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers peers and partners about their sexual health and sexuality
What is the impact at 6-months post-baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services
What is the impact at 12-months post-baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex or used condoms or effective birth control when they had vaginal or anal sex in the past 90 days
Detailed Description:
Background Unintended pregnancy rates among teenagers are higher in rural counties than urban or suburban counties The Teen Talk High School Refresher TTHSR is a sexual health education SHE booster program for older high school students attending school in rural communities that was designed to help address this health disparity Though there is preliminary evidence of the programs effectiveness it has not yet been rigorously evaluated With this study ETR will rigorously evaluate the effectiveness of TTHSR with a randomized controlled trial
TTHSR is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they transition from high school into adulthood in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections STIs It does so using a rights-based social justice-informed approach This program was created by Health Connected a non-profit organization with over 30 years experience in creating evaluating training on and disseminating comprehensive sexual health education to young people and their families throughout California Health Connected is ETRs implementation partner in this study
As a result of the California Health Youth Act which mandates sexual health education in public schools most students this age will have received prior SHE TTHSR is a 5-hour booster intervention delivered in five 1-hour sessions during late high school intended to enhance the effectiveness of previous SHE The TTHSR program will be administered to groups in school settings such as science classes or student advisory sessions We will use trained sexuality education professionals supported by Health Connected to deliver the intervention
Research Questions
The principal purpose of TTHSR is to decrease behaviors that contribute to unintended pregnancy and STIs in students and increase behaviors that support prevention and wellbeing The studys primary research question is
What is the impact at 6-months post baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex or used condoms or effective birth control when they had vaginal or anal sex in the past 90 days
The studys secondary research questions are
What is the impact at 6-months post baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers peers and partners about their sexual health and sexuality
What is the impact at 6-months post-baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services
What is the impact at 12-months post-baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex or used condoms or effective birth control when they had vaginal or anal sex in the past 90 days
Study Design This evaluation is a cluster randomized controlled trial RCT using a school by year approach Our implementation partners Health Connected will engage 16 California schools serving rural students to participate in the study for 2 years Eight of the participating schools will be randomly assigned to the intervention-first group and eight to the comparison-first group Each school will serve as its own control Thus half of the 16 participating schools will receive TTHSR in their first year The other half will be in the comparison-first group and will receive the TTHSR intervention in their second year During the comparison group year schools will administer their normal SHE Each school has an equal chance of being in either the intervention-first or comparison-first group
Recruitment and randomization will occur during year 1 for the first cohort of 8 schools and during project year 2 for the second cohort of 8 schools implementation will occur over years 2 and 3 for the first cohort of schools and over years 3 and 4 for the second cohort
Upon recruitment and before randomization schools will commit to a specific context eg grade level class setting for implementing TTHSR and agree to use that same context for enrollment baseline data collection and study implementation across both years of the study regardless of which condition they are randomized at initial enrollment
We intend to enroll up to 1600 students roughly 50 students per school per year Between 2024 and 2027 we will survey participating students three times at baseline before implementing the TTHSR program 6 months post-baseline and 12 months post-baseline Students that complete a baseline survey will be considered part of the study sample that underwent random assignment and used to calculate attrition
Data Collection The study team plans to administer the baseline survey in-person at the school sites on tablets provided by ETR Audio-assistance will be available for student participants if needed Data will be collected approximately 1-4 weeks prior to implementation with comparable times for schools in the comparison group The project team will offer up to three make-up sessions for the baseline survey In the baseline survey the project team will assess demographic characteristics eg sex assigned at birth gender identity sexual orientation educational status potential moderators eg age raceethnicity relationship status sexual behaviors eg abstinence having sex withwithout condom or contraception use number of partners and potential mediators contraception knowledge contraception attitudes pregnancy attitudes that will be used to establish baseline equivalence of the analytic sample The timing of the implementation may vary across schools for example at some participating schools baseline data collection may occur in the fall while for others it may occur in the spring However within a specific school the timing will be consistent across the two years of study implementation
Survey data will be collected in the same manner for both treatment and control groups by local data collectors hired and trained by ETR The 6-month and 12-month post-program surveys will be collected in the same manner as the baseline survey for youth still enrolled at the school in which they were enrolled at baseline For youth who are no longer enrolled in the same school they will receive an email or text message with a unique link so the survey can be accessed and completed on a device of their choosing ETR will use its field-tested digital tracking mechanism to best support locating youth for follow-up surveys
Analysis Plan We plan to recruit 16 schools across two years and randomize each to an initial experimental condition For the second year of a schools implementation the school will serve in the experimental condition opposite from its initial assignment so that each school serves as its own control this results in a total of 32 school-by-year clusters Each school must enroll grade 11 and grade 12 students to be eligible for participation
The study intends to enroll up to 1600 students in grades 11-12 across the 16 recruited schools We anticipate an analytic sample size of 1408 students 88 response rate at the 6-month follow-up time point and an analytic sample size of 1280 students 80 response rate at the 12-month follow-up time point The project does not anticipate any cluster-level attrition during the study
The study estimates a minimum detectable impact of 825 percentage points relative to a 20 percent prevalence rate or equivalently a minimum detectable effect size of 017 for the primary outcome of sexual abstinenceuse of contraception measured at the 6-month follow-up This is based on the following assumptions alpha 005 power Beta or 080 an expectation that the covariates will explain 20 percent of individual level variation and 50 percent of cluster level variation in the model and an intraclass correlation ICC of 001 The calculations assumed randomized sample size is 1600 students which corresponds to approximately 50 students per recruited school in a given year This model assumes an 88 response rate at the 6-month follow-up and an 80 response rate at the 12-month follow-up for the secondary outcomes and these are based on response rates in a recent evaluation of a high school program conducted in 20 schools The evaluations power calculation was conducted cognizant of data on California high schoolers sexual activity which indicates that 20 of high school students in the state are sexually active The study settled on this minimum detectable impact based on a meta-analysis by Chin et al 2012 of similar group-based comprehensive sexual risk-reduction programs for adolescents in which the average effect size corresponded to a Cohens d of 019
TTHSR is designed to equip 11th and 12th grade students with the knowledge and skills necessary to make informed sexual health decisions as they transition from high school into adulthood in order to prevent behavioral risk factors that contribute to unintended pregnancy and sexually transmitted infections STIs It does so using a rights-based social justice-informed approach This program was created by Health Connected a non-profit organization with over 30 years experience in creating evaluating training on and disseminating comprehensive sexual health education to young people and their families throughout California Health Connected is ETRs implementation partner in this study
As a result of the California Health Youth Act which mandates sexual health education in public schools most students this age will have received prior SHE TTHSR is a 5-hour booster intervention delivered in five 1-hour sessions during late high school intended to enhance the effectiveness of previous SHE The TTHSR program will be administered to groups in school settings such as science classes or student advisory sessions We will use trained sexuality education professionals supported by Health Connected to deliver the intervention
Research Questions
The principal purpose of TTHSR is to decrease behaviors that contribute to unintended pregnancy and STIs in students and increase behaviors that support prevention and wellbeing The studys primary research question is
What is the impact at 6-months post baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex or used condoms or effective birth control when they had vaginal or anal sex in the past 90 days
The studys secondary research questions are
What is the impact at 6-months post baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report improved self-efficacy for self-advocating with healthcare providers peers and partners about their sexual health and sexuality
What is the impact at 6-months post-baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report improved self-efficacy to find and access sexual health services
What is the impact at 12-months post-baseline of TTHSR relative to a business as usual comparison condition on the proportion of youth who self-report they either did not have vaginal or anal sex or used condoms or effective birth control when they had vaginal or anal sex in the past 90 days
Study Design This evaluation is a cluster randomized controlled trial RCT using a school by year approach Our implementation partners Health Connected will engage 16 California schools serving rural students to participate in the study for 2 years Eight of the participating schools will be randomly assigned to the intervention-first group and eight to the comparison-first group Each school will serve as its own control Thus half of the 16 participating schools will receive TTHSR in their first year The other half will be in the comparison-first group and will receive the TTHSR intervention in their second year During the comparison group year schools will administer their normal SHE Each school has an equal chance of being in either the intervention-first or comparison-first group
Recruitment and randomization will occur during year 1 for the first cohort of 8 schools and during project year 2 for the second cohort of 8 schools implementation will occur over years 2 and 3 for the first cohort of schools and over years 3 and 4 for the second cohort
Upon recruitment and before randomization schools will commit to a specific context eg grade level class setting for implementing TTHSR and agree to use that same context for enrollment baseline data collection and study implementation across both years of the study regardless of which condition they are randomized at initial enrollment
We intend to enroll up to 1600 students roughly 50 students per school per year Between 2024 and 2027 we will survey participating students three times at baseline before implementing the TTHSR program 6 months post-baseline and 12 months post-baseline Students that complete a baseline survey will be considered part of the study sample that underwent random assignment and used to calculate attrition
Data Collection The study team plans to administer the baseline survey in-person at the school sites on tablets provided by ETR Audio-assistance will be available for student participants if needed Data will be collected approximately 1-4 weeks prior to implementation with comparable times for schools in the comparison group The project team will offer up to three make-up sessions for the baseline survey In the baseline survey the project team will assess demographic characteristics eg sex assigned at birth gender identity sexual orientation educational status potential moderators eg age raceethnicity relationship status sexual behaviors eg abstinence having sex withwithout condom or contraception use number of partners and potential mediators contraception knowledge contraception attitudes pregnancy attitudes that will be used to establish baseline equivalence of the analytic sample The timing of the implementation may vary across schools for example at some participating schools baseline data collection may occur in the fall while for others it may occur in the spring However within a specific school the timing will be consistent across the two years of study implementation
Survey data will be collected in the same manner for both treatment and control groups by local data collectors hired and trained by ETR The 6-month and 12-month post-program surveys will be collected in the same manner as the baseline survey for youth still enrolled at the school in which they were enrolled at baseline For youth who are no longer enrolled in the same school they will receive an email or text message with a unique link so the survey can be accessed and completed on a device of their choosing ETR will use its field-tested digital tracking mechanism to best support locating youth for follow-up surveys
Analysis Plan We plan to recruit 16 schools across two years and randomize each to an initial experimental condition For the second year of a schools implementation the school will serve in the experimental condition opposite from its initial assignment so that each school serves as its own control this results in a total of 32 school-by-year clusters Each school must enroll grade 11 and grade 12 students to be eligible for participation
The study intends to enroll up to 1600 students in grades 11-12 across the 16 recruited schools We anticipate an analytic sample size of 1408 students 88 response rate at the 6-month follow-up time point and an analytic sample size of 1280 students 80 response rate at the 12-month follow-up time point The project does not anticipate any cluster-level attrition during the study
The study estimates a minimum detectable impact of 825 percentage points relative to a 20 percent prevalence rate or equivalently a minimum detectable effect size of 017 for the primary outcome of sexual abstinenceuse of contraception measured at the 6-month follow-up This is based on the following assumptions alpha 005 power Beta or 080 an expectation that the covariates will explain 20 percent of individual level variation and 50 percent of cluster level variation in the model and an intraclass correlation ICC of 001 The calculations assumed randomized sample size is 1600 students which corresponds to approximately 50 students per recruited school in a given year This model assumes an 88 response rate at the 6-month follow-up and an 80 response rate at the 12-month follow-up for the secondary outcomes and these are based on response rates in a recent evaluation of a high school program conducted in 20 schools The evaluations power calculation was conducted cognizant of data on California high schoolers sexual activity which indicates that 20 of high school students in the state are sexually active The study settled on this minimum detectable impact based on a meta-analysis by Chin et al 2012 of similar group-based comprehensive sexual risk-reduction programs for adolescents in which the average effect size corresponded to a Cohens d of 019
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None