Clinical trial NCT02359422: Evaluation of a Middle School Comprehensive Sexual Health Media Literacy Education Program
Official title: Randomized Control Trial Efficacy Study of a Comprehensive Sexual Health Media Literacy Education Program for Middle School Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Safe Sex
Lead sponsor: Innovation Research & Training
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2015-02-10
Enrollment: 1017
Sex: ALL
Minimum age (years): 10
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to conduct a randomized controlled trial of a media literacy education program for middle school students with the goal of enhancing decision-making skills to prevent early and risky sexual behavior and teen pregnancy, and encourage healthy relationships.


Eligibility criteria: Inclusion Criteria:

* Must be able to read and write in English

Exclusion Criteria:

* None

Primary outcomes:
measure: Change in self-reported sexual activity assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported sexual activity assessed via questionnaire.
timeFrame: 3 months
Secondary outcomes:
measure: Change in self-reported intentions to engage in sexual activity assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported intentions to engage in sexual activity assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported attitude toward sexual activity assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported attitude toward sexual activity assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported attitudes toward contraception assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported attitudes toward contraception assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported attitude toward sexual communication assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported attitude toward sexual communication assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported perceived norms regarding contraception assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported perceived norms regarding contraception assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported self-efficacy to use contraception assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported self-efficacy to use contraception assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported self-efficacy for sexual communication assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported self-efficacy for sexual communication assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported intentions for condom/contraception use assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported intentions for condom/contraception use assessed via questionnaire.
timeFrame: 3 months
measure: Change in self-reported intentions for sexual communication assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in self-reported intentions for sexual communication assessed via questionnaire.
timeFrame: 3 months
Other outcomes:
measure: Change in media deconstruction skills assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in media deconstruction skills assessed via questionnaire.
timeFrame: 3 months
measure: Change in perceived realism of media messages assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in perceived realism of media messages assessed via questionnaire.
timeFrame: 3 months
measure: Change in perceived similarity to media messages assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in perceived similarity to media messages assessed via questionnaire.
timeFrame: 3 months
measure: Change in perceived desirability of media messages assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in perceived desirability of media messages assessed via questionnaire.
timeFrame: 3 months
measure: Change in media skepticism assessed via self-report questionnaire.
timeFrame: 2 weeks
measure: Change in media skepticism assessed via self-report questionnaire.
timeFrame: 3 months
measure: Change in identification to media messages assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in identification to media messages assessed via questionnaire.
timeFrame: 3 months
measure: Change in acceptance of dating violence norms assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in acceptance of dating violence norms assessed via questionnaire.
timeFrame: 3 months
measure: Change in acceptance of gender role norms assessed via questionnaire.
timeFrame: 2 weeks
measure: Change in acceptance of gender role norms assessed via questionnaire.
timeFrame: 3 months
Locations:
city: Durham
country: United States
facility: innovation Research & Training
state: North Carolina
Study officials:
affiliation: Innovation Research & Training
name: Tracy M Scull, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Scull TM, Kupersmidt JB, Malik CV, Morgan-Lopez AA. Using Media Literacy Education for Adolescent Sexual Health Promotion in Middle School: Randomized Control Trial of Media Aware. J Health Commun. 2018;23(12):1051-1063. doi: 10.1080/10810730.2018.1548669. Epub 2018 Nov 23.