Pathways 2 Success

NCT06831123 | Recruiting Phase 1

• 1 other identifier: STUDY00024346
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This study involves a 3-arm randomized controlled trial designed to investigate the feasibility and acceptability of three preventive interventions designed to reduce risk for escalations in adolescent conduct problems. High school students identified to be at risk for conduct problems will be randomly assigned to one of three intervention options, including a mindfulness-based program, a mindfulness-based program augmented by a new mobile app, and a life skills program. Assessments related to intervention outcomes will be completed by adolescents, parents/guardians, and teachers at baseline, 2 weeks post-intervention, and at a 3-month follow-up.

Conditions

Conduct Disorder; Oppositional Defiant Disorder

Outcome Measures

Primary Outcomes (2)

• Add Health Self-Report of Delinquency

  A rating scale used to evaluate the number of times in the past month adolescents have committed 17 different antisocial acts. A rating scale used to evaluate the number of times in the past month adolescents have committed 17 different antisocial acts. Scores range from 0 to 17, with higher scores reflecting greater engagement in delinquent behaviors.

  Baseline; up to 15 weeks; through study completion, approximately 6 months

• Behavioral Rating Inventory of Executive Functioning - Second Edition Screening Form

  A 12-item rating scale that evaluates executive functioning A 12-item rating scale that evaluates executive functioning. Scores are reported as T-scores, with higher scores reflecting greater levels of executive functioning difficulties.

  Baseline; up to 15 weeks; through study completion, approximately 6 months

Study Arms (3)

The Learning to breathe (L2B)

EXPERIMENTAL

randomized to the Learning to Breathe (L2B) mindfulness intervention

Behavioral: L2B

L2B+App

EXPERIMENTAL

randomized to the Learning to Breathe plus App condition

Behavioral: L2B + App

Skills for Success

EXPERIMENTAL

randomized to Skills for Success

Behavioral: skills for success

Interventions

L2B BEHAVIORAL

a 6-session, group-based intervention that helps youth develop mindfulness skills

The Learning to breathe (L2B)

L2B + App BEHAVIORAL

the Learning to Breathe plus App condition, the 6-session L2B intervention augmented by a mobile application designed to support the use of mindfulness skills in daily life

L2B+App

skills for success BEHAVIORAL

a 6-session life skills intervention designed to support decision making and healthy relationships

Skills for Success

Eligibility Criteria

• Age: 13 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• A 9th or 10th grade student in a partner school district
• Referral due to elevated social/emotional risk indicated on a standardized screening tool or a referral from school support staff due to concerns about school-based conduct problems
• Adolescents and their parents must be fluent in English

You may not qualify if:

• Currently receiving special education services (i.e., an IEP) due to a behavioral or emotional disturbance
• Existing diagnoses of autism spectrum disorder, pervasive developmental disorders, developmental/intellectual disability, or serious psychiatric disorders requiring specialized mental health treatment (e.g., psychosis, bipolar, substance use disorder, etc.)

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

MeSH Terms

Conditions

Conduct Disorder; Oppositional Defiant Disorder

Interventions

Amyloid

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Officials

• Timothy Piehler

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Morrell

CONTACT

612-624-2600; morre006@umn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessment technicians will not be aware of participants assigned study conditions
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly assigned to one of three different intervention conditions.

Study Record Dates

• First Submitted: February 7, 2025
• First Posted: February 17, 2025
• Study Start: March 12, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)