D-Stress Baltimore: School-based Mindfulness Instruction
NCT ID: NCT02493218
Last Updated: 2018-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
400 participants
INTERVENTIONAL
2012-10-31
2016-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The investigators propose to conduct a randomized controlled trial of the 12-week school-based DSB program compared with a 12-week school-based health education control program at Elev8 schools among 5th-8th graders to assess if DSB program is beneficial for mental health and behavioral problems among public middle-school students.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Advancing Dynamic And Personalized Training Study
NCT07051330
Behavior, Biology and Well-Being Study
NCT05183867
Healthy Mind Healthy You: A Study of Mindfulness
NCT03844321
Healthy Minds Comparison Study
NCT06282523
Behavior, Biology and Well-Being Study
NCT06213701
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program of stress-reduction techniques which has been found to be beneficial for adults in decreasing anxiety and depression, improving positive emotions, and reducing anger.
The investigators propose to conduct a randomized controlled trial of the 12-week school-based DSB program compared with a 12-week school-based health education control program at Elev8 schools among 5th-8th graders. The investigators hypothesize that the D-Stress Baltimore Program will reduce negative emotions, including hostility, and improve coping.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
PREVENTION
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Mindfulness Instruction
Instruction on mindfulness concepts and practices. Classes are 45-90 minutes each and held weekly for 12 weeks.
Mindfulness Instruction
Age-appropriate instruction on mindfulness concepts and practices, adapted from the mindfulness-based stress reduction (MBSR) program. Classes are 45-90 minutes each and held weekly for 12 weeks.
Health Education Instruction
Instruction on general health and wellness. Classes are 45-90 minutes each and held weekly for 12 weeks.
Health Education
Age-appropriate health education concepts and topics. Classes are 45-90 minutes each and held weekly for 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mindfulness Instruction
Age-appropriate instruction on mindfulness concepts and practices, adapted from the mindfulness-based stress reduction (MBSR) program. Classes are 45-90 minutes each and held weekly for 12 weeks.
Health Education
Age-appropriate health education concepts and topics. Classes are 45-90 minutes each and held weekly for 12 weeks.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
9 Years
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Elev8 Baltimore
OTHER
Abell Foundation
OTHER
University of Chicago
OTHER
Robert Wood Johnson Foundation
OTHER
Johns Hopkins University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Erica Sibinga, MD, MHS
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins School of Medicine
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Tench Tilghman Elementary Middle School
Baltimore, Maryland, United States
Collington Square Elementary Middle School
Baltimore, Maryland, United States
Commodore John Rodgers Elementary Middle School
Baltimore, Maryland, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sibinga EM, Webb L, Ghazarian SR, Ellen JM. School-Based Mindfulness Instruction: An RCT. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-2532. Epub 2015 Dec 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NA_00077391
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.