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Pregnancy in AdolescenceTRAILNCT05182736

Taking Responsible Actions in Life Evaluation

A study testing TRAIL intervention in people with Pregnancy in Adolescence, run by Portland State University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Pregnancy in Adolescence
What is being tested?
TRAIL intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,261 participants
Where
No sites listed yet
Study dates
23 Aug 2016to Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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.
Being tested
TRAIL intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TRAIL interventionBehavioural

    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.

Study groups in NCT05182736
Study groupRoleWhat they receive
TRAIL interventionExperimentalThe 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)
Receives: Behavioral: TRAIL intervention
ControlNo interventionStudents in the comparison schools receive the normal ninth grade health curriculum, "Reproductive and Health Safety Education."

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: At 18 month post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2022
  2. Study start23 Aug 2016
  3. Primary completion29 Oct 2019
  4. Study completionDec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
4,261 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05182736
Sponsor's protocol ID
163673
Acronym
TRAIL
Status last verified
Dec 2021
First submitted
15 Sep 2021
Last updated
10 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing TRAIL intervention in people with Pregnancy in Adolescence, run by Portland State University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Participant report of having not been abstinent in the past three months at 18-month follow up assessment (time frame: At 18 month post intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2022.

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