Conduct DisorderPhase 1/2NCT06831123
Pathways 2 Success
A Phase 1/2 study testing L2B, L2B + App and skills for success in people with Conduct Disorder and Oppositional Defiant Disorder, run by University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Conduct Disorder, Oppositional Defiant Disorder
- What is being tested?
- L2B, L2B + App and skills for success
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2025to 28 Feb 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55414
Timothy Piehler, tpiehler@umn.edu
About this study
Official title: Pathways 2 Success: A Study of School-Based Prevention Programs Supporting Positive Adolescent Development
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
- Being tested
- L2B, L2B + App, skills for success
- Medical subject headings
- Conduct Disorder, Oppositional Defiant Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L2BBehavioural
a 6-session, group-based intervention that helps youth develop mindfulness skills
L2B + AppBehavioural
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 successBehavioural
a 6-session life skills intervention designed to support decision making and healthy relationships
| Study group | Role | What they receive |
|---|---|---|
| The Learning to breathe (L2B) | Experimental | randomized to the Learning to Breathe (L2B) mindfulness intervention Receives: Behavioral: L2B |
| L2B+App | Experimental | randomized to the Learning to Breathe plus App condition Receives: Behavioral: L2B + App |
| Skills for Success | Experimental | randomized to Skills for Success Receives: Behavioral: skills for success |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline; up to 15 weeks; through study completion, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start12 Mar 2025
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Conduct DisorderStudies 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to one of three different intervention conditions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Timothy Piehler, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06831123
- Sponsor's protocol ID
- STUDY00024346
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2025
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathways 2 Success: A Study of School-Based Prevention Programs Supporting Positive Adolescent Development
- ClinicalTrials.gov ID
- NCT06831123
- Acronym / sponsor ID
- STUDY00024346
- Conditions
- Conduct Disorder, Oppositional Defiant Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 12 Mar 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 17 Feb 2025 (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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Participants will be randomly assigned to one of three different intervention conditions.
| Arm | Type | Receives |
|---|---|---|
| The Learning to breathe (L2B) | Experimental | Behavioral: L2Brandomized to the Learning to Breathe (L2B) mindfulness intervention |
| L2B+App | Experimental | Behavioral: L2B + Apprandomized to the Learning to Breathe plus App condition |
| Skills for Success | Experimental | Behavioral: skills for successrandomized to Skills for Success |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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.)
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 |
|---|---|---|
| L2Ba 6-session, group-based intervention that helps youth develop mindfulness skills | Behavioural | The Learning to breathe (L2B) |
| L2B + Appthe 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 | Behavioural | L2B+App |
| skills for successa 6-session life skills intervention designed to support decision making and healthy relationships | Behavioural | Skills for Success |
Primary outcome
Add Health Self-Report of Delinquency
Time frame: Baseline; up to 15 weeks; through study completion, approximately 6 months
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.
Behavioral Rating Inventory of Executive Functioning - Second Edition Screening Form
Time frame: Baseline; up to 15 weeks; through study completion, approximately 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
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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.
Timothy Piehler principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing L2B, L2B + App and skills for success in people with Conduct Disorder and Oppositional Defiant Disorder, run by University of Minnesota at 1 site in United States.
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 2 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: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Morrell (612-624-2600, morre006@umn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Add Health Self-Report of Delinquency (time frame: Baseline; up to 15 weeks; through study completion, approximately 6 months). The study lists 2 primary outcomes in all. 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 13 Apr 2026.