Clinical trial NCT05569070: Evaluation of Young United Parents
Official title: Evaluation of Young United Parents
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Teen Pregnancy Prevention
Keywords: Teen Pregnancy Prevention
Lead sponsor: The Policy & Research Group
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2022-10-06
Enrollment: 1400
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of effective non-barrier contraception
timeFrame: Assessed three months after the intervention period has ended
measure: Times having vaginal sex without a condom
timeFrame: Assessed three months after the intervention period has ended
Secondary outcomes:
measure: Contraceptive knowledge
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: Condom knowledge
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: STI knowledge
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: Condom negotiation self-efficacy
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: Contraceptive use self-efficacy
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: STI testing self-efficacy
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: Self-care self-efficacy
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: Goal setting self-efficacy
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: Condom use outcome expectations
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: Contraceptive use outcome expectations
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: Perceived pregnancy fatalism
timeFrame: Assessed immediately post-intervention and three months after the intervention period has ended
measure: Use of effective non-barrier contraception
timeFrame: Assessed twelve months after the intervention period has ended
measure: Consistent use of effective non-barrier contraception
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Frequency of emergency contraception use
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Use of effective non-barrier contraception during last vaginal sex
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Times having vaginal sex without a condom
timeFrame: Assessed twelve months after the intervention period has ended
measure: Use of condoms during last vaginal sex
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Times having completely unprotected during last vaginal sex
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Completely unprotected during last vaginal sex
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Dual methods of protection during recent vaginal sex
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Dual methods of protection during last vaginal sex
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Recent STI testing
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Recent STI acquisition
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Recent repeat pregnancy
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Recent repeat unintended pregnancy
timeFrame: Assessed three and twelve months after the intervention period has ended
measure: Parenting competence
timeFrame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended
measure: Stigma
timeFrame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended
measure: Social support
timeFrame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended
measure: Well-being
timeFrame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended
measure: Goal attainment
timeFrame: Assessed immediately post-intervention and three and twelve months after the intervention period has ended
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: The Policy & Research Group
state: Louisiana
Study officials:
affiliation: The Policy & Research Group
name: Eric Jenner, PhD
role: PRINCIPAL_INVESTIGATOR
References: