Evaluation of Young United Parents

Teen Pregnancy Prevention Clinical Trial

— YUP  

Official title:

Evaluation of Young United Parents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05569070
• Other study ID #: 90AP2692-01-00
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2022
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2022
• Source: The Policy & Research Group
• Contact: Hilary Demby, MPH
• Phone: 504-865-1545
• Email: hilary[@]policyandresearch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1400
• Est. completion date: November 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 20 Years

Eligibility

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
• Identified as fraudulent

Related Conditions & MeSH terms

• Teen Pregnancy Prevention

Intervention

Other:
• Guided 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.
• Nutrition 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.

Locations

Country	Name	City	State
United States	The Policy & Research Group	New Orleans	Louisiana

Sponsors (2)

Lead Sponsor	Collaborator
The Policy & Research Group	Department of Health and Human Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Use of effective non-barrier contraception	Participant self-report on whether (or not) they are currently using effective non-barrier contraception (IUD, implant, oral contraceptive pill, injection, patch, or ring)	Assessed three months after the intervention period has ended
Primary	Times having vaginal sex without a condom	Participant self-report on the number of times having vaginal sex without using a condom during the past three months	Assessed three months after the intervention period has ended
Secondary	Contraceptive knowledge	Proportion of items related to contraceptive knowledge to which the participant answers correctly	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	Condom knowledge	Proportion of items related to condom knowledge to which the participant answers correctly	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	STI knowledge	Proportion of items related to STI knowledge to which the participant answers correctly	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	Condom negotiation self-efficacy	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)	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	Contraceptive use self-efficacy	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)	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	STI testing self-efficacy	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)	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	Self-care self-efficacy	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)	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	Goal setting self-efficacy	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)	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	Condom use outcome expectations	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)	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	Contraceptive use outcome expectations	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)	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	Perceived pregnancy fatalism	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)	Assessed immediately post-intervention and three months after the intervention period has ended
Secondary	Use of effective non-barrier contraception	Participant self-report on whether (or not) they are currently using effective non-barrier contraception (IUD, implant, oral contraceptive pill, injection, patch, or ring)	Assessed twelve months after the intervention period has ended
Secondary	Consistent use of effective non-barrier contraception	Participant self-report on whether (or not) they have been using effective non-barrier contraception consistently for the past three months	Assessed three and twelve months after the intervention period has ended
Secondary	Frequency of emergency contraception use	Participant self-report on the number of times they have used emergency contraception after vaginal sex in the past three months	Assessed three and twelve months after the intervention period has ended
Secondary	Use of effective non-barrier contraception during last vaginal sex	Participant self-report on whether (or not) they used effective non-barrier contraception during the last time they had vaginal sex	Assessed three and twelve months after the intervention period has ended
Secondary	Times having vaginal sex without a condom	Participant self-report on the number of times having vaginal sex without using a condom during the past three months	Assessed twelve months after the intervention period has ended
Secondary	Use of condoms during last vaginal sex	Participant self-report on whether (or not) they used condoms during the last time they had vaginal sex	Assessed three and twelve months after the intervention period has ended
Secondary	Times having completely unprotected during last vaginal sex	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	Assessed three and twelve months after the intervention period has ended
Secondary	Completely unprotected during last vaginal sex	Participant self-report on whether (or not) their last vaginal sex act was completely unprotected (using neither a condom nor effective non-barrier contraception)	Assessed three and twelve months after the intervention period has ended
Secondary	Dual methods of protection during recent vaginal sex	Participant self-report on whether (or not) they used dual methods of protection (both condoms and effective non-barrier contraception) during recent vaginal sex	Assessed three and twelve months after the intervention period has ended
Secondary	Dual methods of protection during last vaginal sex	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	Assessed three and twelve months after the intervention period has ended
Secondary	Recent STI testing	Participant self-report on whether (or not) they received recent STI testing	Assessed three and twelve months after the intervention period has ended
Secondary	Recent STI acquisition	Participant self-report on whether (or not) they recently tested positive for STIs	Assessed three and twelve months after the intervention period has ended
Secondary	Recent repeat pregnancy	Participant self-report on whether (or not) they have been pregnant in the recent past	Assessed three and twelve months after the intervention period has ended
Secondary	Recent repeat unintended pregnancy	Participant self-report on whether (or not) they have been pregnant in the recent past with a pregnancy that was unintended	Assessed three and twelve months after the intervention period has ended
Secondary	Parenting competence	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)	Assessed immediately post-intervention and three and twelve months after the intervention period has ended
Secondary	Stigma	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)	Assessed immediately post-intervention and three and twelve months after the intervention period has ended
Secondary	Social support	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)	Assessed immediately post-intervention and three and twelve months after the intervention period has ended
Secondary	Well-being	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)	Assessed immediately post-intervention and three and twelve months after the intervention period has ended
Secondary	Goal attainment	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)	Assessed immediately post-intervention and three and twelve months after the intervention period has ended