Taking Responsible Actions in Life Evaluation

NCT05182736 | Completed

• 1 other identifier: 163673
• Study Type: interventional
• Target: 4,261
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Pregnancy in Adolescence

Outcome Measures

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

  At 18 month post intervention

Study Arms (2)

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)

Behavioral: TRAIL intervention

Control

NO INTERVENTION

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

Interventions

TRAIL intervention BEHAVIORAL

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.

TRAIL intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Portland State University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Students in comparison arm received intervention as usual. Students in the comparison schools (as well as those in the intervention condition) receive the normal ninth grade health curriculum, "Reproductive and Health Safety Education," which is intended to cover three essential standards 1) Healthy and effective interpersonal communication and relationships, 2) Abstinence from sexual intercourse as a positive choice for young people, and 3) Strategies that develop and maintain reproductive and sexual health. All schools in North Carolina provide sex education in accordance with the 2009 Health Youth Act in seventh, eighth, and ninth grades
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Public Health

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: January 10, 2022
• Study Start: August 23, 2016
• Primary Completion: October 29, 2019
• Study Completion: December 1, 2020
• Last Updated: January 10, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share