Evaluation of a Middle School Comprehensive Sexual Health Media Literacy Education Program

Safe Sex Clinical Trial

— MASH  

Official title:

Randomized Control Trial Efficacy Study of a Comprehensive Sexual Health Media Literacy Education Program for Middle School Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02359422
• Other study ID #: iRT-2R44HD061193-02-RCT
• Secondary ID: 2R44HD061193-02
• Status: Completed
• Phase: N/A
• First received: September 3, 2014
• Last updated: November 19, 2015
• Start date: April 2014
• Est. completion date: August 2015

Study information

• Verified date: November 2015
• Source: Innovation Research & Training
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1017
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 10 Years to 15 Years

Eligibility

Inclusion Criteria:

• Must be able to read and write in English

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Safe Sex

Intervention

Behavioral:
• Media Aware-Sexual Health
10-lesson middle school, comprehensive sexual health media literacy education program. Each lesson take approximately 50 minutes to teach and will be taught every school day for 2 weeks.

Locations

Country	Name	City	State
United States	innovation Research & Training	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Innovation Research & Training	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in media deconstruction skills assessed via questionnaire.		2 weeks	No
Other	Change in media deconstruction skills assessed via questionnaire.		3 months	No
Other	Change in perceived realism of media messages assessed via questionnaire.		2 weeks	No
Other	Change in perceived realism of media messages assessed via questionnaire.		3 months	No
Other	Change in perceived similarity to media messages assessed via questionnaire.		2 weeks	No
Other	Change in perceived similarity to media messages assessed via questionnaire.		3 months	No
Other	Change in perceived desirability of media messages assessed via questionnaire.		2 weeks	No
Other	Change in perceived desirability of media messages assessed via questionnaire.		3 months	No
Other	Change in media skepticism assessed via self-report questionnaire.		2 weeks	No
Other	Change in media skepticism assessed via self-report questionnaire.		3 months	No
Other	Change in identification to media messages assessed via questionnaire.		2 weeks	No
Other	Change in identification to media messages assessed via questionnaire.		3 months	No
Other	Change in acceptance of dating violence norms assessed via questionnaire.		2 weeks	No
Other	Change in acceptance of dating violence norms assessed via questionnaire.		3 months	No
Other	Change in acceptance of gender role norms assessed via questionnaire.		2 weeks	No
Other	Change in acceptance of gender role norms assessed via questionnaire.		3 months	No
Primary	Change in self-reported sexual activity assessed via questionnaire.		2 weeks	No
Primary	Change in self-reported sexual activity assessed via questionnaire.		3 months	No
Secondary	Change in self-reported intentions to engage in sexual activity assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported intentions to engage in sexual activity assessed via questionnaire.		3 months	No
Secondary	Change in self-reported attitude toward sexual activity assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported attitude toward sexual activity assessed via questionnaire.		3 months	No
Secondary	Change in self-reported attitudes toward contraception assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported attitudes toward contraception assessed via questionnaire.		3 months	No
Secondary	Change in self-reported attitude toward sexual communication assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported attitude toward sexual communication assessed via questionnaire.		3 months	No
Secondary	Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported perceived norms regarding sexual activity assessed via questionnaire.		3 months	No
Secondary	Change in self-reported perceived norms regarding contraception assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported perceived norms regarding contraception assessed via questionnaire.		3 months	No
Secondary	Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported perceived norms regarding sexual communication assessed via questionnaire.		3 months	No
Secondary	Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported self-efficacy to refusal sexual activity assessed via questionnaire.		3 months	No
Secondary	Change in self-reported self-efficacy to use contraception assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported self-efficacy to use contraception assessed via questionnaire.		3 months	No
Secondary	Change in self-reported self-efficacy for sexual communication assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported self-efficacy for sexual communication assessed via questionnaire.		3 months	No
Secondary	Change in self-reported intentions for condom/contraception use assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported intentions for condom/contraception use assessed via questionnaire.		3 months	No
Secondary	Change in self-reported intentions for sexual communication assessed via questionnaire.		2 weeks	No
Secondary	Change in self-reported intentions for sexual communication assessed via questionnaire.		3 months	No