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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02493218
Other study ID # NA_00077391
Secondary ID
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
Health authority
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:

Study Design


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
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