Overview

This trial is active, not recruiting.

Conditions coping, stress disorders, post-traumatic, mental health wellness 1
Treatments mindfulness instruction, health education
Sponsor Johns Hopkins University
Collaborator Elev8 Baltimore
Start date October 2012
End date May 2016
Trial size 400 participants
Trial identifier NCT02493218, NA_00077391

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Instruction on mindfulness concepts and practices. Classes are 45-90 minutes each and held weekly for 12 weeks.
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)
Instruction on general health and wellness. 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.

Primary Outcomes

Measure
Depressive symptoms
time frame: 3-9 months
Affect Measures: Positive and Negative Affect Scale; State Trait Anger Expressivity Index; Differential Emotions Scale
time frame: 3-9 months
Anxiety assessed by Multidimensional Anxiety Scale of Childhood.
time frame: 3-9 months

Secondary Outcomes

Measure
Coping Questionnaire
time frame: 3-9 months
Post-traumatic stress symptoms
time frame: 3-9 months

Eligibility Criteria

Male or female participants from 9 years up to 18 years old.

Inclusion Criteria: - 5th - 8th graders in select Baltimore City schools Exclusion Criteria: - N/A

Additional Information

Official title D-Stress Baltimore: School-based Mindfulness Instruction for Primary Prevention of Mental Health and Behavioral Problems in Middle School
Principal investigator Erica Sibinga, MD, MHS
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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Johns Hopkins University.