ClinicalTrials.gg
CompletedNCT05182736TRAILUpdated Jan 10, 2022

Taking Responsible Actions in Life Evaluation

An interventional study of TRAIL intervention in Pregnancy in Adolescence, sponsored by Portland State University. Completed. Per ClinicalTrials.gov, last updated 2022-01-10.

Sponsored by Portland State University · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 5 years after the study started (first participant enrolled Aug 2016, registered Sep 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
4,261
Allocation
Randomized
Sex
All
01

Study summary

TRAIL is a multi-tiered school-wide intervention delivered to middle and high school aged youth. The overall goal of the TRAIL project is to decrease rates of teen births by increasing the capacity of students to make healthy decisions regarding sexual health through the use of a school-wide pregnancy prevention model. The program will be delivered to youth in eighth and ninth grade at the intervention sites.

Read the detailed description

The TRAIL program is comprised of a multi-tier system of strategies:

  1. Universal Strategies (delivered school-wide) Universal strategies impact the entire school via a school-wide social norms marketing campaign and school-climate change activities. A social norms marketing campaign saturates the entire high school or middle school site through monthly newsletters, posters, and video campaigns to educate students on healthy behaviors and dispel their misperceptions of peers' sexual activity. School staff trainings and professional development activities focus on enhancing protective factors for students to reduce the effects of stressful life events and trauma, improving classroom management, linking students to resources, and improving the overall school climate for students and staff. Activities include trainings to staff and teachers on trauma-informed care, positive youth development, available teen friendly resources via the Network of Care teen resource guide and app, and available support programs to the parents. Three trainings are provided to key health staff and one training is provided to the entire school staff. Healthcare linkages and referrals are measured by school nurses and reviewed by program staff to assess and address any barriers to accessing services related to teen sexual health and related healthcare services.
  2. Targeted Strategies (delivered to the target grade level in the evaluation sample) Targeted strategies include an in-school curriculum and service learning component, which impact all ninth grade students at the intervention high schools and all eighth grade students at the intervention middle schools. Elevate is the in-school adolescent leadership curriculum program that provides teens with the knowledge, skills, and support they need to make healthy decisions regarding their future, including those related to sexual health. Elevate provides peer mentoring and an interactive curriculum covering topics such as setting and achieving goals; self-assessment; issues with family, friends, and self; media awareness; self-esteem; leadership; communication and negotiation skills; and future orientation. In addition, all eighth and ninth graders complete service learning projects to develop and deepen a positive attachment to the school and community. This tier includes five 90-minute sessions (7.5 hours) of classroom programing and ten hours of service learning.
  3. Intensive Strategies (delivered to select at-risk students) Intensive strategies are intended for a subset of youth and their caregivers with identified increased risk-factors, and they include peer mentoring, after-school running/positive youth development programming, summer programming, and parent workshop support. Although all eighth and ninth grade students and their caregivers are eligible to receive intensive strategies, a subset identified by the schools are be targeted. Participation is always voluntary. High school and college mentors are carefully selected and trained to act as peer mentors who collaborate to raise awareness about teen health issues in the community and promote healthy decision making. These mentors assist the universal, targeted, and intensive strategy activities. TRAIL enrichment is a twenty 90-minute session comprehensive noncompetitive running program that promotes future orientation, an active lifestyle, nutritious eating, and healthy decision-making including decisions regarding sexual health for adolescents to achieve holistic health and be successful adults. Summer Advantage opportunities provide meaningful, positive, and supervised activities for youth during the summer month. Activities are made available through community partners to allow students to experience various positive youth development outlets in the community, which are related to health, education, and the arts. Parent workshops are offered to equip parents and community members with prevention education and a system to reinforce positive norms for students.
02

Conditions studied

  • Pregnancy in Adolescence
03

In context

Lead sponsor

Portland State University is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Parental passive consent (parents did not withdraw consent)
  • 9th grade at baseline (cohort 1) and 8th grade at baseline (cohort 2)
  • English or Spanish speaking

Exclusion criteria

Exclusion Criteria:

  • Cognitive impairment
  • Repeat students (students repeating 9th grade for cohort 1 or 8th grade for cohort 2)
  • Moved out of district prior to randomization
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
4,261 participants (actual)

Study arms

  • Experimental
    TRAIL intervention

    The TRAIL program is comprised of a multi-tier system of strategies: 1. Universal Strategies (delivered school-wide), 2. Targeted Strategies (delivered to the target grade level in the evaluation sample) 3. Intensive Strategies (delivered to select at-risk students)

    Behavioral: TRAIL intervention

  • No intervention
    Control

    Students in the comparison schools receive the normal ninth grade health curriculum, "Reproductive and Health Safety Education."

Interventions

  • BehavioralTRAIL intervention

    The TRAIL program is comprised of a multi-tier system of strategies: Universal strategies impact the entire school via a school-wide social norms marketing campaign and school-climate change activities. School staff trainings and professional development activities focus on enhancing protective factors for students to reduce the effects of stressful life events and trauma, improving classroom management, linking students to resources, and improving the overall school climate for students and staff. Targeted strategies include an in-school curriculum and service learning component, which impact all ninth grade students at the intervention high schools and all eighth grade students at the intervention middle schools. Intensive strategies are intended for a subset of youth and their caregivers with identified increased risk-factors, and they include peer mentoring, after-school running/positive youth development programming, summer programming, and parent workshop support.

06

What researchers measure

Primary outcomes

  1. Participant report of having not been abstinent in the past three months at 18-month follow up assessment

    Reporting not having been abstinent in the past three months

    Time frame: At 18 month post intervention

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Aug 2016 to primary completion in Oct 2019, 38 months.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 15, 2021
First posted
Jan 10, 2022
StartActual
Aug 23, 2016
Primary completionActual
Oct 29, 2019
CompletionActual
Dec 2020
Last update
Jan 10, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05182736
Lead sponsor
Portland State University
Responsible party
Lynne Messer (Associate Professor of Public Health, Portland State University) — Principal investigator
First posted
Jan 10, 2022
Start date
Aug 23, 2016
Primary completion
Oct 29, 2019
Completion
Dec 2020
Last update
Jan 10, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

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