Pathways 2 Success

NCT ID: NCT06831123

Last Updated: 2025-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Conduct Disorder Oppositional Defiant Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants will be randomly assigned to one of three different intervention conditions.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
Assessment technicians will not be aware of participants assigned study conditions

Study Groups

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The Learning to breathe (L2B)

randomized to the Learning to Breathe (L2B) mindfulness intervention

Group Type EXPERIMENTAL

L2B

Intervention Type BEHAVIORAL

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

L2B+App

randomized to the Learning to Breathe plus App condition

Group Type EXPERIMENTAL

L2B + App

Intervention Type 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

Skills for Success

randomized to Skills for Success

Group Type EXPERIMENTAL

skills for success

Intervention Type BEHAVIORAL

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

Interventions

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L2B

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

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

skills for success

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.)
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Timothy Piehler

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Nicole Morrell

Role: CONTACT

612-624-2600

Facility Contacts

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Timothy Piehler

Role: primary

Other Identifiers

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STUDY00024346

Identifier Type: -

Identifier Source: org_study_id

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