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D-Stress Baltimore: School-based Mindfulness Instruction

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Elev8 Baltimore
Abell Foundation
University of Chicago
Robert Wood Johnson Foundation
Information provided by (Responsible Party):
Erica Sibinga, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT02493218
First received: June 26, 2015
Last updated: July 8, 2015
Last verified: July 2015
  Purpose

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.


Condition Intervention
Coping
Stress Disorders, Post-Traumatic
Mental Health Wellness 1
Behavioral: Mindfulness Instruction
Behavioral: Health Education

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: D-Stress Baltimore: School-based Mindfulness Instruction for Primary Prevention of Mental Health and Behavioral Problems in Middle School

Resource links provided by NLM:


Further study details as provided by Erica Sibinga, Johns Hopkins University:

Primary Outcome Measures:
  • Depressive symptoms [ Time Frame: 3-9 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)

  • Affect Measures: Positive and Negative Affect Scale; State Trait Anger Expressivity Index; Differential Emotions Scale [ Time Frame: 3-9 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.

  • Anxiety assessed by Multidimensional Anxiety Scale of Childhood. [ Time Frame: 3-9 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.


Secondary Outcome Measures:
  • Coping Questionnaire [ Time Frame: 3-9 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).

  • Post-traumatic stress symptoms [ Time Frame: 3-9 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



Estimated Enrollment: 400
Study Start Date: October 2012
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   9 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02493218

Locations
United States, Maryland
Collington Square Elementary Middle School
Baltimore, Maryland, United States, 21213
Commodore John Rodgers Elementary Middle School
Baltimore, Maryland, United States, 21231
Tench Tilghman Elementary Middle School
Batlimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Elev8 Baltimore
Abell Foundation
University of Chicago
Robert Wood Johnson Foundation
Investigators
Principal Investigator: Erica Sibinga, MD, MHS Johns Hopkins School of Medicine
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Erica Sibinga, Principal Investigator and Associate Professor, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02493218     History of Changes
Other Study ID Numbers: NA_00077391
Study First Received: June 26, 2015
Last Updated: July 8, 2015

Keywords provided by Erica Sibinga, Johns Hopkins University:
mindfulness
intervention
african american
youth
stress
poverty

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 25, 2017