D-Stress Baltimore: School-based Mindfulness Instruction

Stress Disorders, Post-Traumatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493218
• Other study ID #: NA_00077391
• Status: Completed
• Phase: N/A
• First received: June 26, 2015
• Last updated: January 16, 2018
• Start date: October 2012
• Est. completion date: May 2016

Study information

• Verified date: January 2018
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 9 Years to 18 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Collington Square Elementary Middle School	Baltimore	Maryland
United States	Commodore John Rodgers Elementary Middle School	Baltimore	Maryland
United States	Tench Tilghman Elementary Middle School	Baltimore	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
Johns Hopkins University	Abell Foundation, Elev8 Baltimore, Robert Wood Johnson Foundation, University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	9 months
Primary	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.	9 months
Primary	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.	9 months
Secondary	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).	9 months
Secondary	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	9 months