D-Stress Baltimore: School-based Mindfulness Instruction

Sponsor

Johns Hopkins University (Other)

Overall Status

Completed

CT.gov ID

NCT02493218

Collaborator

Elev8 Baltimore (Other), Abell Foundation (Other), University of Chicago (Other), Robert Wood Johnson Foundation (Other)

400

Enrollment

Locations

Arms

Duration (Months)

133.3

Patients Per Site

3.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Coping Stress Disorders, Post-Traumatic Mental Health Wellness 1	Behavioral: Mindfulness Instruction Behavioral: Health Education	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Oct 1, 2012

Actual Primary Completion Date :

May 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

9 Years to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

5th - 8th graders in select Baltimore City schools

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tench Tilghman Elementary Middle School	Baltimore	Maryland	United States	21205
2	Collington Square Elementary Middle School	Baltimore	Maryland	United States	21213
3	Commodore John Rodgers Elementary Middle School	Baltimore	Maryland	United States	21231