NCT02359422

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,017

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 3, 2014

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 10, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

November 20, 2015

Status Verified

November 1, 2015

Enrollment Period

1.3 years

First QC Date

September 3, 2014

Last Update Submit

November 19, 2015

Conditions

Safe Sex

Outcome Measures

Primary Outcomes (2)

  • Change in self-reported sexual activity assessed via questionnaire.

    2 weeks

  • Change in self-reported sexual activity assessed via questionnaire.

    3 months

Secondary Outcomes (24)

  • Change in self-reported intentions to engage in sexual activity assessed via questionnaire.

    2 weeks

  • Change in self-reported intentions to engage in sexual activity assessed via questionnaire.

    3 months

  • Change in self-reported attitude toward sexual activity assessed via questionnaire.

    2 weeks

  • Change in self-reported attitude toward sexual activity assessed via questionnaire.

    3 months

  • Change in self-reported attitudes toward contraception assessed via questionnaire.

    2 weeks

  • +19 more secondary outcomes

Other Outcomes (16)

  • Change in media deconstruction skills assessed via questionnaire.

    2 weeks

  • Change in media deconstruction skills assessed via questionnaire.

    3 months

  • Change in perceived realism of media messages assessed via questionnaire.

    2 weeks

  • +13 more other outcomes

Study Arms (2)

Media Aware-Sexual Health

EXPERIMENTAL

10-lesson middle school, comprehensive sexual health program developed based upon the Message Interpretation Processing model designed to increase critical thinking skills about media messages and reduce risky sexual behaviors.

Behavioral: Media Aware-Sexual Health

Wait-list control

NO INTERVENTION

Interventions

Media Aware-Sexual HealthBEHAVIORAL

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.

Media Aware-Sexual Health

Eligibility Criteria

Age10 Years - 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Must be able to read and write in English

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

innovation Research & Training

Durham, North Carolina, 27707, United States

Location

Related Publications (1)

  • 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.

    PMID: 30468408DERIVED

MeSH Terms

Conditions

Safe Sex

Condition Hierarchy (Ancestors)

Sexual BehaviorBehavior

Study Officials

  • Tracy M Scull, PhD

    Innovation Research & Training

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

February 10, 2015

Study Start

April 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

November 20, 2015

Record last verified: 2015-11

Locations

US(1)