D-Stress Baltimore: School-based Mindfulness Instruction

Not Applicable

Completed

• Conditions: Coping; Stress Disorders, Post-Traumatic; Mental Health Wellness 1
• Interventions: Behavioral: Mindfulness Instruction; Behavioral: Health Education

• Registration Number: NCT02493218
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-07-08
• Study First Posted: 2015-07-09
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-16
• Last Update Posted: 2018-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Mindfulness Instruction	Mindfulness Instruction	Instruction on mindfulness concepts and practices. Classes are 45-90 minutes each and held weekly for 12 weeks.
Health Education Instruction	Health Education	Instruction on general health and wellness. Classes are 45-90 minutes each and held weekly for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Depressive symptoms	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	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.	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

Name	Time	Method
Coping Questionnaire	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	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

Trial Locations

Locations (3)

Tench Tilghman Elementary Middle School; 🇺🇸 Baltimore, Maryland, United States

Collington Square Elementary Middle School; 🇺🇸 Baltimore, Maryland, United States

Commodore John Rodgers Elementary Middle School; 🇺🇸 Baltimore, Maryland, United States