D-Stress Baltimore: School-based Mindfulness Instruction

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: Stress Disorders, Post-Traumatic; Mental Health Wellness 1; Coping
• Intervention / Treatment: Behavioral: Mindfulness Instruction; Behavioral: Health Education

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

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

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	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.	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	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	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

• 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

General Publications

• 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.

Study record dates

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: mindfulness; stress; intervention; youth; poverty; african american
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
• Other Study ID Numbers: NA_00077391