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Clinical Trials/NCT02493218
NCT02493218CompletedNot Applicable

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

Johns Hopkins University3 sites in 1 country400 target enrollmentStarted: October 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
400
Locations
3
Primary Endpoint
Depressive symptoms

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Prevention
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
9 Years to 18 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Arms & Interventions

Mindfulness Instruction

Experimental

Instruction on mindfulness concepts and practices. Classes are 45-90 minutes each and held weekly for 12 weeks.

Intervention: Mindfulness Instruction (Behavioral)

Health Education Instruction

Active Comparator

Instruction on general health and wellness. Classes are 45-90 minutes each and held weekly for 12 weeks.

Intervention: Health Education (Behavioral)

Outcomes

Primary Outcomes

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)

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.

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

  • Coping Questionnaire(9 months)
  • Post-traumatic stress symptoms(9 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (3)

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