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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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:
- 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.
- 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.
- 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.
- Conditions
- Pregnancy in Adolescence
- 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 group | Role | What they receive |
|---|---|---|
| TRAIL intervention | Experimental | 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) Receives: Behavioral: TRAIL intervention |
| Control | No intervention | Students 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.
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.
- First posted10 Jan 2022
- Study start23 Aug 2016
- Primary completion29 Oct 2019
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy in AdolescenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Portland State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lynne Messer, Portland State University
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Taking Responsible Actions in Life Evaluation
- ClinicalTrials.gov ID
- NCT05182736
- Acronym / sponsor ID
- TRAIL / 163673
- Conditions
- Pregnancy in Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,261 participants (actual)
- Lead sponsor
- Portland State UniversityUniversity, hospital or other
- Study start
- 23 Aug 2016 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 10 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The TRAIL program is comprised of a multi-tier system of strategies:
- 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.
- 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.
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRAIL intervention | Experimental | Behavioral: TRAIL interventionThe 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) |
| Control | No intervention | –Students in the comparison schools receive the normal ninth grade health curriculum, "Reproductive and Health Safety Education." |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- Cognitive impairment
- Repeat students (students repeating 9th grade for cohort 1 or 8th grade for cohort 2)
- Moved out of district prior to randomization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRAIL interventionThe 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. | Behavioural | TRAIL intervention |
Primary outcome
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
Reporting not having been abstinent in the past three months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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.