Evaluation of Young United Parents (YUP)

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.

Study Overview

• Status: Recruiting
• Conditions: Teen Pregnancy Prevention
• Intervention / Treatment: Other: Guided Young United Parents! Website Intervention; Other: Nutrition Website

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hilary Demby, MPH; Phone Number: 504-865-1545; Email: hilary@policyandresearch.com
• Study Contact Backup: Name: Elyse Mason, MPH; Phone Number: 504-865-1545; Email: elyse@policyandresearch.com

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Recruiting
      • The Policy & Research Group
      • Contact: Hilary Demby, MPH; Phone Number: 504-865-1545; Email: hilary@policyandresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Guided Young United Parents! (YUP!) Website Intervention; The Guided YUP! website intervention is the confirmatory contrast, which will involve two months of directed use of the YUP! website.	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.
Sham Comparator: Nutrition Website; The nutrition website is the control counterfactual condition.	Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: The Policy & Research Group
• Collaborators: Department of Health and Human Services
• Investigators: Principal Investigator: Eric Jenner, PhD, The Policy & Research Group

Study record dates

Study Major Dates

• Study Start (Actual): October 10, 2022
• Primary Completion (Anticipated): February 28, 2025
• Study Completion (Anticipated): November 30, 2025

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 3, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Teen Pregnancy Prevention
• Other Study ID Numbers: 90AP2692-01-00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: A dataset will be prepared at the conclusion of the study, which includes de-identified individual-level data on all study participants who contributed self-report data. Respondents will be represented only by a research ID number. Included in the dataset will be self-report data collected across all survey administrations (including demographic characteristics, sexual behaviors, and theoretical antecedents to those behaviors) and select information on program participation (e.g., which program components were completed). Basic data cleaning steps will be taken in order to ensure data are unidentifiable and to increase usability.
• IPD Sharing Time Frame: The individual participant dataset will become available twelve months after the study has concluded.
• IPD Sharing Supporting Information Type: Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No