Clinical trial NCT02493218: D-Stress Baltimore: School-based Mindfulness Instruction
Official title: D-Stress Baltimore: School-based Mindfulness Instruction for Primary Prevention of Mental Health and Behavioral Problems in Middle School
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coping
Stress Disorders, Post-Traumatic
Mental Health Wellness 1
Keywords: mindfulness
intervention
african american
youth
stress
poverty
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Elev8 Baltimore
name: Abell Foundation
name: University of Chicago
name: Robert Wood Johnson Foundation
First posted: 2015-07-09
Enrollment: 400
Sex: ALL
Minimum age (years): 9
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* N/A

Primary outcomes:
measure: Depressive symptoms
timeFrame: 9 months
measure: Affect Measures: Positive and Negative Affect Scale; State Trait Anger Expressivity Index; Differential Emotions Scale
timeFrame: 9 months
measure: Anxiety assessed by Multidimensional Anxiety Scale of Childhood.
timeFrame: 9 months
Secondary outcomes:
measure: Coping Questionnaire
timeFrame: 9 months
measure: Post-traumatic stress symptoms
timeFrame: 9 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Tench Tilghman Elementary Middle School
state: Maryland
city: Baltimore
country: United States
facility: Collington Square Elementary Middle School
state: Maryland
city: Baltimore
country: United States
facility: Commodore John Rodgers Elementary Middle School
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Medicine
name: Erica Sibinga, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sibinga EM, Webb L, Ghazarian SR, Ellen JM. School-Based Mindfulness Instruction: An RCT. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-2532. Epub 2015 Dec 18.