Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

University of Minnesota

Code:

NCT06831123

Conditions

Conduct Disorder

Oppositional Defiant Disorder

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Interventions

L2B

L2B + App

skills for success

Study Details

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

Study ID

NCT06831123

Start date

Mar 12, 2025

Status verified date

Apr, 2026

Completion date

Feb 28, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 13 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. A 9th or 10th grade student in a partner school district
2. 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
3. Adolescents and their parents must be fluent in English

Exclusion Criteria:

1. Currently receiving special education services (i.e., an IEP) due to a behavioral or emotional disturbance
2. 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.)

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: The Learning to breathe (L2B)

randomized to the Learning to Breathe (L2B) mindfulness intervention

experimental: L2B+App

randomized to the Learning to Breathe plus App condition

experimental: Skills for Success

randomized to Skills for Success

Interventions

L2B

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

L2B + App

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

skills for success

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

Primary outcome measure

  • Add Health Self-Report of Delinquency [ Time Frame: Baseline; up to 15 weeks; through study completion, approximately 6 months ]
  • Behavioral Rating Inventory of Executive Functioning - Second Edition Screening Form [ Time Frame: Baseline; up to 15 weeks; through study completion, approximately 6 months ]

Central Contacts and Locations

Central contacts

Nicole Morrell

612-624-2600morre006@umn.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55414

Contacts

Timothy Piehler

tpiehler@umn.edu

More Information

Sponsor

University of Minnesota

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-04-13.