D-Stress Baltimore: School-based Mindfulness Instruction

January 16, 2018 updated by: Johns Hopkins University

D-Stress Baltimore: School-based Mindfulness Instruction for Primary Prevention of Mental Health and Behavioral Problems in Middle School

Effective strategies to ameliorate the negative effects of stressful urban living are greatly needed. D-Stress Baltimore (DSB) is an evidence-based mindfulness-based instructional program of stress-reduction techniques, found to reduce mental health problems across many adult populations.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Urban youth in Baltimore City are under significant and inevitable stresses, including violent neighborhoods, failing schools, and interpersonal conflict. Effective strategies to ameliorate the negative effects of stressful urban living are greatly needed.

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.

Study Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Tench Tilghman Elementary Middle School
      • Baltimore, Maryland, United States, 21213
        • Collington Square Elementary Middle School
      • Baltimore, Maryland, United States, 21231
        • Commodore John Rodgers Elementary Middle School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 5th - 8th graders in select Baltimore City schools

Exclusion Criteria:

  • N/A

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Instruction
Instruction on mindfulness concepts and practices. Classes are 45-90 minutes each and held weekly for 12 weeks.
Behavioral: 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.
Active Comparator: Health Education Instruction
Instruction on general health and wellness. Classes are 45-90 minutes each and held weekly for 12 weeks.
Behavioral: Health Education
Age-appropriate health education concepts and topics. Classes are 45-90 minutes each and held weekly for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: 9 months
Assessment of impact of Mindfulness instruction versus Health Education instruction as measured by scores on mental health questionnaire administered at baseline, and then 3 and 9 months later. Children's Depression Inventory - Short Form (CDI-S)
9 months
Affect Measures: Positive and Negative Affect Scale; State Trait Anger Expressivity Index; Differential Emotions Scale
Time Frame: 9 months
Assessment of impact of Mindfulness instruction versus Health Education instruction as measured by scores on mental health questionnaire administered at baseline, and then 3 and 9 months later.
9 months
Anxiety assessed by Multidimensional Anxiety Scale of Childhood.
Time Frame: 9 months
Assessment of impact of Mindfulness instruction versus Health Education instruction as measured by scores on mental health questionnaire administered at baseline, and then 3 and 9 months later.
9 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coping Questionnaire
Time Frame: 9 months
Assessment of impact of Mindfulness instruction versus Health Education instruction on coping as measured by scores on questionnaire administered at baseline, and then 3 and 9 months later. Specific coping measures used are: Brief COPE Inventory; the Coping Self-Efficacy Scale (CSE); and Children's Response Style Questionnaire (CRSQ).
9 months
Post-traumatic stress symptoms
Time Frame: 9 months

Assessment of impact of Mindfulness instruction versus Health Education instruction as measured by scores on questionnaire administered at baseline, and then 3 and 9 months later.

Children's Post-traumatic Stress Symptoms
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

University of Chicago
Robert Wood Johnson Foundation
Abell Foundation
Elev8 Baltimore

Investigators

  • Principal Investigator: Erica Sibinga, MD, MHS, Johns Hopkins School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

July 8, 2015

First Posted (Estimate)

July 9, 2015

Study Record Updates

Last Update Posted (Actual)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NA_00077391

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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