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Completed

NCT Number: NCT02493218

D-Stress Baltimore: School-based Mindfulness Instruction

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.

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Key information

Conditions

Coping Mental Disorders Mental Health Wellness 1 Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

9 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Collington Square Elementary Middle School, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • N/A

Treatment and study plan

Mindfulness Instruction

Behavioral

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

Behavioral

Age-appropriate health education concepts and topics. Classes are 45-90 minutes each and held weekly for 12 weeks.

Primary outcomes

  1. 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)

  2. 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.

  3. 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.

Secondary outcomes

  1. 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).

  2. 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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Abell Foundation
  • Elev8 Baltimore
  • Robert Wood Johnson Foundation
  • University of Chicago

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jul 9, 2015
Registry last updated
Jan 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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