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NCT Number: NCT05569070

Evaluation of Young United Parents

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Teen Pregnancy Prevention

Age range

15 year–20 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Policy & Research Group

New Orleans, Louisiana, 70118, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Guided Young United Parents! Website Intervention

Other

Participants assigned to Guided YUP! will receive two months of structured use of the YUP! website intervention, which involves weekly review of written and video content, meetings with near-peer mentors, use of the goal tool, interaction with the online community, and receipt of tips and affirmations.

Nutrition Website

Other

Participants assigned to the Nutrition Website will be provided with the link to the MyPlate website, which is maintained by the U.S. Department of Agriculture. At the enrollment session, participants will be given brief instruction during the enrollment session about features available on the website that may be interesting to them and encouraged to engage in any of the website or app features at whatever level they are comfortable with. No further direction will be provided to them after the enrollment session.

Primary outcomes

  1. Use of effective non-barrier contraception

    Time frame: Assessed three months after the intervention period has ended

    Participant self-report on whether (or not) they are currently using effective non-barrier contraception (IUD, implant, oral contraceptive pill, injection, patch, or ring)

  2. Times having vaginal sex without a condom

    Time frame: Assessed three months after the intervention period has ended

    Participant self-report on the number of times having vaginal sex without using a condom during the past three months

Secondary outcomes

  1. Contraceptive knowledge

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Proportion of items related to contraceptive knowledge to which the participant answers correctly

  2. Condom knowledge

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Proportion of items related to condom knowledge to which the participant answers correctly

  3. STI knowledge

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Proportion of items related to STI knowledge to which the participant answers correctly

  4. Condom negotiation self-efficacy

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of confidence in being able to negotiate condom use, with scores ranging from 1 (indicating low confidence) to 7 (indicating high confidence)

  5. Contraceptive use self-efficacy

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of confidence in being able to use contraceptives, with scores ranging from 1 (indicating low confidence) to 7 (indicating high confidence)

  6. STI testing self-efficacy

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of confidence in being able to get STI testing, with scores ranging from 1 (indicating low confidence) to 7 (indicating high confidence)

  7. Self-care self-efficacy

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of confidence in being able to take care of themselves, with scores ranging from 1 (indicating low confidence) to 7 (indicating high confidence)

  8. Goal setting self-efficacy

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of confidence in being able to set personal goals, with scores ranging from 1 (indicating low confidence) to 7 (indicating high confidence)

  9. Condom use outcome expectations

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of agreement with statements about the outcomes expected with condom use, with scores ranging from 1 (indicating low agreement) to 7 (indicating high agreement)

  10. Contraceptive use outcome expectations

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of agreement with statements about the outcomes expected with contraceptive use, with scores ranging from 1 (indicating low agreement) to 7 (indicating high agreement)

  11. Perceived pregnancy fatalism

    Time frame: Assessed immediately post-intervention and three months after the intervention period has ended

    Mean score to one item that asks an individual to self-report their level of agreement with a statement related to what degree they have control over becoming pregnant, with scores ranging from 1 (indicating low agreement) to 7 (indicating high agreement)

  12. Use of effective non-barrier contraception

    Time frame: Assessed twelve months after the intervention period has ended

    Participant self-report on whether (or not) they are currently using effective non-barrier contraception (IUD, implant, oral contraceptive pill, injection, patch, or ring)

  13. Consistent use of effective non-barrier contraception

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) they have been using effective non-barrier contraception consistently for the past three months

  14. Frequency of emergency contraception use

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on the number of times they have used emergency contraception after vaginal sex in the past three months

  15. Use of effective non-barrier contraception during last vaginal sex

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) they used effective non-barrier contraception during the last time they had vaginal sex

  16. Times having vaginal sex without a condom

    Time frame: Assessed twelve months after the intervention period has ended

    Participant self-report on the number of times having vaginal sex without using a condom during the past three months

  17. Use of condoms during last vaginal sex

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) they used condoms during the last time they had vaginal sex

  18. Times having completely unprotected during last vaginal sex

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on the number of times having vaginal sex with neither a condom nor effective non-barrier contraception during the past three months

  19. Completely unprotected during last vaginal sex

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) their last vaginal sex act was completely unprotected (using neither a condom nor effective non-barrier contraception)

  20. Dual methods of protection during recent vaginal sex

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) they used dual methods of protection (both condoms and effective non-barrier contraception) during recent vaginal sex

  21. Dual methods of protection during last vaginal sex

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) they used dual methods of protection (both condoms and effective non-barrier contraception) during the last time they had vaginal sex

  22. Recent STI testing

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) they received recent STI testing

  23. Recent STI acquisition

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) they recently tested positive for STIs

  24. Recent repeat pregnancy

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) they have been pregnant in the recent past

  25. Recent repeat unintended pregnancy

    Time frame: Assessed three and twelve months after the intervention period has ended

    Participant self-report on whether (or not) they have been pregnant in the recent past with a pregnancy that was unintended

  26. Parenting competence

    Time frame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of agreement with statements about their perceived competence in their ability to take care of their child(ren), with scores ranging from 1 (indicating low agreement) to 7 (indicating high agreement)

  27. Stigma

    Time frame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of agreement with statements about the perceived stigma they experience due to being a young parent, with scores ranging from 1 (indicating low agreement) to 7 (indicating high agreement)

  28. Social support

    Time frame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of agreement with statements about their perceived social support, with scores ranging from 1 (indicating low agreement) to 7 (indicating high agreement)

  29. Well-being

    Time frame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended

    Mean scale score of items that ask an individual to self-report their level of agreement with statements about their perceived well-being, with scores ranging from 1 (indicating low agreement) to 7 (indicating high agreement)

  30. Goal attainment

    Time frame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended

    Mean scale score of items that ask an individual to what extent statements about their ability to set and achieve goals are similar to them, with scores ranging from 1 (indicating not at all like them) to 5 (indicating exactly like them)

Sponsors and collaborators

Lead sponsor

The Policy & Research Group

Other

Collaborators

  • Department of Health and Human Services

Registry information

Acronym: YUP

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Oct 6, 2022
Registry last updated
Apr 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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