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Evaluation of Young United Parents (YUP)

T

The Policy & Research Group

Status

Active, not recruiting

Conditions

Teen Pregnancy Prevention

Treatments

Other: Nutrition Website
Other: Guided Young United Parents! Website Intervention

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT05569070
90AP2692-01-00

Details and patient eligibility

About

The purpose of the study is to determine the impact of the offer to participate in the Young United Parents! (YUP!) intervention relative to the control condition on use of effective non-barrier contraception and frequency of vaginal sex without condoms three months after the intervention period has concluded.

Full description

The Policy & Research Group (PRG) will be rigorously evaluating an innovative intervention, Young United Parents! (YUP!), which is a website-based program designed to help young parents ages 15-22 avoid unplanned, repeat pregnancy and sexually transmitted infections (STIs), reach their personal goals, and thrive in all areas of life. The mobile-optimized website contains 50 articles and over 100 personal narrative videos of highly diverse young parents and experts. The YUP! intervention includes: 1) video and written content on six topics (sexual health and birth control; healthy relationships; self-care; reaching your goals; parenting; and pregnancy and birth); 2) access to near-peer mentors; 3) a goal-setting tool; 4) daily tips, reminders, and motivational messages; 5) links and referrals to support services; and 6) membership in the YUP! online community of young parents.

PRG will conduct an implementation evaluation and an impact evaluation of a structured version of YUP!, called Guided YUP!. Guided YUP! involves a two-month program experience during which participants are directed through a dashboard on the website to review between 15-35 minutes of particular website content each week. Participants will also be paired with a near-peer mentor who will schedule virtual interactions with them every two weeks, for a total of at least five interactions over the course of the two-month intervention period. All interactions will be held via the YUP! participant dashboard and are expected to last between 5-10 minutes. The aim of these interactions is for the near-peer mentor to offer support and guidance, using motivational interviewing techniques, as the participants go through the Guided YUP! program. Additionally, Guided YUP! participants will be asked to outline and complete at least one goal during the two-month intervention period, using the goal tool on the website. Guided YUP! participants will also receive automatically generated tips and affirmations through the website and have access to the YUP! online community to participate in, if desired.

PRG will assess the efficacy of Guided YUP! using a randomized controlled trial. The study will target young mothers ages 15-20 who are currently caring for their child(ren) and not pregnant or trying to become pregnant. The primary aim of the study will be to investigate the impact of the intervention on two self-reported sexual behaviors: 1) use of effective non-barrier contraception and 2) frequency of vaginal sex without condoms. In addition, the study will include exploratory investigations of the following self-reported sexual behaviors and theoretically relevant antecedents to these behaviors: 1) frequency of sexually transmitted infection (STI) testing; 2) frequency of completely unprotected vaginal sex; 3) incidence of pregnancy; 4) incidence of STIs; 5) condom, contraceptive, and STI knowledge; 6) condom negotiation, contraceptive use, and STI testing self-efficacy; 7) condom and contraceptive use outcome expectations; and 8) perceived pregnancy fatalism. Finally, the study will explore the impact of the intervention on measures that assess participants' perceptions of their healthy relationships, self-care and well-being, goal achievement, and parenting competence.

Outcomes will be assessed using self-reported, participant-level data gathered using a structured questionnaire administered at four time points: baseline (enrollment); post-intervention (two months after baseline); three months post-intervention (five months after the baseline); and twelve months post-intervention (fourteen months after the baseline).

Starting in October 2022 and continuing for 21 months, 1400 participants from around the United States will be enrolled virtually. The final two years of the grant will be used to collect follow-up data from study participants; conduct implementation and impact evaluation analysis, reporting, and dissemination efforts.

Enrollment

1,400 estimated patients

Sex

Female

Ages

15 to 20 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Biological female aged 15-20
  • Has given birth to a child they currently provide care for
  • Reports having penile-vaginal sex at least one time in past three months
  • Fluent in English (able to read and comprehend the online intervention materials, which are available only in English)
  • Owns or has regular access to a personal device (smartphone, laptop, tablet) with internet access
  • United States resident
  • Provides informed assent or consent for study participation

Exclusion criteria

  • Currently pregnant
  • Currently trying to become pregnant
  • Previously registered to use the YUP! website
  • Enrolled in an ongoing PRG-run TPP study
  • Identified as fraudulent

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,400 participants in 2 patient groups

Guided Young United Parents! (YUP!) Website Intervention
Experimental group
Description:
The Guided YUP! website intervention is the treatment condition, which will involve two months of directed use of the YUP! website.
Treatment:
Other: Guided Young United Parents! Website Intervention
Nutrition Website
Sham Comparator group
Description:
The nutrition website is the control condition.
Treatment:
Other: Nutrition Website

Trial contacts and locations

1

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Central trial contact

Hilary Demby, MPH; Elyse Mason, MPH

Data sourced from clinicaltrials.gov

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