Pathways 2 Success
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age13-17
SponsorUniversity of Minnesota
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
L2B
Behaviorala 6-session, group-based intervention that helps youth develop mindfulness skills
L2B + App
Behavioralthe 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
Behaviorala 6-session life skills intervention designed to support decision making and healthy relationships
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: The Learning to breathe (L2B)Experimental treatment 1 intervention
Group B: L2B+AppExperimental treatment 1 intervention
Group C: Skills for SuccessExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline; up to 15 weeks; through study completion, approximately 6 months2
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.
Time frame
Baseline; up to 15 weeks; through study completion, approximately 6 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov