Clinical Trial: Making Healthy Decisions

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: An Integrated Group-Individual Curriculum to Prevent Teen Pregnancy

Brief Summary: The purpose of Making Healthy Decisions is to design and rigorously evaluate a new sexual health education program, "Your Move" (YM) against a nutrition control program, "Eat Smart" (ES). YM is intended to improve teen females' (ages 14-19) ability to make healthy sexual decisions with the ultimate goal of reducing unplanned pregnancies and STIs.

Detailed Summary:

Making Healthy Decisions includes two technology-based interventions designed to improve teen females' healthy decision making in relation to sexual relationships (YM) and nutrition (ES).

Health educators from Planned Parenthood are trained to implement both YM and ES at youth-serving community organizations in their geographic area across several U.S. states. In a multi-site randomized controlled trial, females ages 14-19 are recruited from their local community-based organization (CBO) into groups/cohorts of 8-12.

Each cohort is randomly assigned to participate in one of the two interventions prior to baseline data collection.

Participants attend seven 75-minute program sessions that include facilitator-led games, activities, and discussions as well as personal reflection time in which girls practiced healthy decision making individually on an electronic tablet.

Self-reported survey data related to attitudes, knowledge, and behavior around sex and nutrition are collected at baseline as well as 3 months and 9 months after the intervention ends.

Current Primary Outcome:

• Number of sexual partners for vaginal intercourse [ Time Frame: 3 months post intervention ]
  Number of partners with whom had vaginal sex
• Number of sexual partners for vaginal intercourse [ Time Frame: 9 months post intervention ]
  Number of partners with whom had vaginal sex
• Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms [ Time Frame: 3 months post intervention ]
  Number of times reported having vaginal sex without hormonal contraception, copper IUD, condoms, or insertive condoms
• Number of incidents of vaginal sex without using hormonal contraception, copper IUD, or condoms [ Time Frame: 9 months post intervention ]
  Number of times reported having vaginal sex without hormonal contraception, copper
• Number of incidents of vaginal sex without condoms [ Time Frame: 3 months post intervention ]
  Number of times reported having vaginal sex without using condoms or insertive condoms
• Number of incidents of vaginal sex without condoms [ Time Frame: 9 months post intervention ]
  Number of times reported having vaginal sex without using condoms or insertive condoms

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of incidents of vaginal intercourse [ Time Frame: 3 and 9 months post intervention ]
  Number of times had vaginal intercourse in the past 3 months
• Condom errors or failure [ Time Frame: 3 and 9 months post intervention ]
  Experienced any of 10 specific condom errors/failures during any condom use in the past 3 months (breakage, slippage, starting sex before putting condom on, removing condom before sex complete, open package with sharp object, use oil-based lubricant, put on condom before full erection, put on condom inside out and or flip it, had a problem that damaged condom & did not have another available, squeeze air from tip)
• Number of incidents of vaginal, oral, or anal sex without using condoms [ Time Frame: 3 and 9 months post intervention ]
  Number of times reported having vaginal, oral, or anal sex without using condoms or insertive condoms
• Number of sexual partners for vaginal, oral, or anal intercourse [ Time Frame: 3 and 9 months post intervention ]
  Number of partners with whom had vaginal, oral, or anal sex
• Perceived self efficacy to communicate about sexual boundaries and condom use [ Time Frame: 3 and 9 months post intervention ]
  Efficacy in communicating about sexual activity and condom use

Original Secondary Outcome: Same as current

Information By: Carnegie Mellon University

Dates:
Date Received: November 28, 2016
Date Started: October 2016
Date Completion: June 2020
Last Updated: December 14, 2016
Last Verified: December 2016