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D-Stress Baltimore: School-based Mindfulness Instruction

Primary Purpose

Coping, Stress Disorders, Post-Traumatic, Mental Health Wellness 1

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Instruction
Health Education
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coping focused on measuring mindfulness, intervention, african american, youth, stress, poverty

Eligibility Criteria

9 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A

Sites / Locations

  • Tench Tilghman Elementary Middle School
  • Collington Square Elementary Middle School
  • Commodore John Rodgers Elementary Middle School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Instruction

Health Education Instruction

Arm Description

Instruction on mindfulness concepts and practices. Classes are 45-90 minutes each and held weekly for 12 weeks.

Instruction on general health and wellness. Classes are 45-90 minutes each and held weekly for 12 weeks.

Outcomes

Primary Outcome Measures

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)
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.
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.

Secondary Outcome Measures

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).
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

Full Information

First Posted
June 26, 2015
Last Updated
January 16, 2018
Sponsor
Johns Hopkins University
Collaborators
Elev8 Baltimore, Abell Foundation, University of Chicago, Robert Wood Johnson Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02493218
Brief Title
D-Stress Baltimore: School-based Mindfulness Instruction
Official Title
D-Stress Baltimore: School-based Mindfulness Instruction for Primary Prevention of Mental Health and Behavioral Problems in Middle School
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Elev8 Baltimore, Abell Foundation, University of Chicago, Robert Wood Johnson Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coping, Stress Disorders, Post-Traumatic, Mental Health Wellness 1
Keywords
mindfulness, intervention, african american, youth, stress, poverty

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Instruction
Arm Type
Experimental
Arm Description
Instruction on mindfulness concepts and practices. Classes are 45-90 minutes each and held weekly for 12 weeks.
Arm Title
Health Education Instruction
Arm Type
Active Comparator
Arm Description
Instruction on general health and wellness. Classes are 45-90 minutes each and held weekly for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Instruction
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Age-appropriate health education concepts and topics. Classes are 45-90 minutes each and held weekly for 12 weeks.
Primary Outcome Measure Information:
Title
Depressive symptoms
Description
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)
Time Frame
9 months
Title
Affect Measures: Positive and Negative Affect Scale; State Trait Anger Expressivity Index; Differential Emotions Scale
Description
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.
Time Frame
9 months
Title
Anxiety assessed by Multidimensional Anxiety Scale of Childhood.
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Coping Questionnaire
Description
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).
Time Frame
9 months
Title
Post-traumatic stress symptoms
Description
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
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 5th - 8th graders in select Baltimore City schools Exclusion Criteria: N/A
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Sibinga, MD, MHS
Organizational Affiliation
Johns Hopkins School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tench Tilghman Elementary Middle School
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Collington Square Elementary Middle School
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21213
Country
United States
Facility Name
Commodore John Rodgers Elementary Middle School
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26684478
Citation
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.
Results Reference
derived

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D-Stress Baltimore: School-based Mindfulness Instruction

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