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Evaluation of Young United Parents

Evaluation of Young United Parents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05569070
Acronym
YUP
Enrollment
1400
Registered
2022-10-06
Start date
2022-10-10
Completion date
2026-09-30
Last updated
2026-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Teen Pregnancy Prevention

Keywords

Teen Pregnancy Prevention

Brief summary

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.

Detailed 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.

Interventions

OTHERGuided Young United Parents! Website Intervention

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.

OTHERNutrition Website

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.

Sponsors

The Policy & Research Group
Lead SponsorOTHER
Department of Health and Human Services
CollaboratorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 20 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Use of effective non-barrier contraceptionAssessed three months after the intervention period has endedParticipant self-report on whether (or not) they are currently using effective non-barrier contraception (IUD, implant, oral contraceptive pill, injection, patch, or ring)
Times having vaginal sex without a condomAssessed three months after the intervention period has endedParticipant self-report on the number of times having vaginal sex without using a condom during the past three months

Secondary

MeasureTime frameDescription
Contraceptive knowledgeAssessed immediately post-intervention and three months after the intervention period has endedProportion of items related to contraceptive knowledge to which the participant answers correctly
Condom knowledgeAssessed immediately post-intervention and three months after the intervention period has endedProportion of items related to condom knowledge to which the participant answers correctly
STI knowledgeAssessed immediately post-intervention and three months after the intervention period has endedProportion of items related to STI knowledge to which the participant answers correctly
Condom negotiation self-efficacyAssessed immediately post-intervention and three months after the intervention period has endedMean 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)
Contraceptive use self-efficacyAssessed immediately post-intervention and three months after the intervention period has endedMean 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)
STI testing self-efficacyAssessed immediately post-intervention and three months after the intervention period has endedMean 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)
Self-care self-efficacyAssessed immediately post-intervention and three months after the intervention period has endedMean 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)
Goal setting self-efficacyAssessed immediately post-intervention and three months after the intervention period has endedMean 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)
Condom use outcome expectationsAssessed immediately post-intervention and three months after the intervention period has endedMean 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)
Contraceptive use outcome expectationsAssessed immediately post-intervention and three months after the intervention period has endedMean 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)
Perceived pregnancy fatalismAssessed immediately post-intervention and three months after the intervention period has endedMean 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)
Use of effective non-barrier contraceptionAssessed twelve months after the intervention period has endedParticipant self-report on whether (or not) they are currently using effective non-barrier contraception (IUD, implant, oral contraceptive pill, injection, patch, or ring)
Consistent use of effective non-barrier contraceptionAssessed three and twelve months after the intervention period has endedParticipant self-report on whether (or not) they have been using effective non-barrier contraception consistently for the past three months
Frequency of emergency contraception useAssessed three and twelve months after the intervention period has endedParticipant self-report on the number of times they have used emergency contraception after vaginal sex in the past three months
Use of effective non-barrier contraception during last vaginal sexAssessed three and twelve months after the intervention period has endedParticipant self-report on whether (or not) they used effective non-barrier contraception during the last time they had vaginal sex
Times having vaginal sex without a condomAssessed twelve months after the intervention period has endedParticipant self-report on the number of times having vaginal sex without using a condom during the past three months
Use of condoms during last vaginal sexAssessed three and twelve months after the intervention period has endedParticipant self-report on whether (or not) they used condoms during the last time they had vaginal sex
Times having completely unprotected during last vaginal sexAssessed three and twelve months after the intervention period has endedParticipant self-report on the number of times having vaginal sex with neither a condom nor effective non-barrier contraception during the past three months
Completely unprotected during last vaginal sexAssessed three and twelve months after the intervention period has endedParticipant self-report on whether (or not) their last vaginal sex act was completely unprotected (using neither a condom nor effective non-barrier contraception)
Dual methods of protection during recent vaginal sexAssessed three and twelve months after the intervention period has endedParticipant self-report on whether (or not) they used dual methods of protection (both condoms and effective non-barrier contraception) during recent vaginal sex
Dual methods of protection during last vaginal sexAssessed three and twelve months after the intervention period has endedParticipant 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
Recent STI testingAssessed three and twelve months after the intervention period has endedParticipant self-report on whether (or not) they received recent STI testing
Recent STI acquisitionAssessed three and twelve months after the intervention period has endedParticipant self-report on whether (or not) they recently tested positive for STIs
Recent repeat pregnancyAssessed three and twelve months after the intervention period has endedParticipant self-report on whether (or not) they have been pregnant in the recent past
Recent repeat unintended pregnancyAssessed three and twelve months after the intervention period has endedParticipant self-report on whether (or not) they have been pregnant in the recent past with a pregnancy that was unintended
Parenting competenceAssessed immediately post-intervention and three and twelve months after the intervention period has endedMean 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)
StigmaAssessed immediately post-intervention and three and twelve months after the intervention period has endedMean 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)
Social supportAssessed immediately post-intervention and three and twelve months after the intervention period has endedMean 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)
Well-beingAssessed immediately post-intervention and three and twelve months after the intervention period has endedMean 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)
Goal attainmentAssessed immediately post-intervention and three and twelve months after the intervention period has endedMean 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)

Countries

United States

Contacts

PRINCIPAL_INVESTIGATOREric Jenner, PhD

The Policy & Research Group

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 28, 2026