NCT02493218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
2.7 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 9, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

January 18, 2018

Status Verified

January 1, 2018

Enrollment Period

3.6 years

First QC Date

June 26, 2015

Last Update Submit

January 16, 2018

Conditions

CopingStress Disorders, Post-TraumaticMental Health Wellness 1

Keywords

mindfulnessinterventionafrican americanyouthstresspoverty

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Coping Questionnaire

    9 months

  • Post-traumatic stress symptoms

    9 months

Study Arms (2)

Mindfulness Instruction

EXPERIMENTAL

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

Behavioral: Mindfulness Instruction

Health Education Instruction

ACTIVE COMPARATOR

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

Behavioral: Health Education

Interventions

Mindfulness InstructionBEHAVIORAL

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.

Mindfulness Instruction
Health EducationBEHAVIORAL

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

Health Education Instruction

Eligibility Criteria

Age9 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • th - 8th graders in select Baltimore City schools

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Tench Tilghman Elementary Middle School

Baltimore, Maryland, 21205, United States

Location

Collington Square Elementary Middle School

Baltimore, Maryland, 21213, United States

Location

Commodore John Rodgers Elementary Middle School

Baltimore, Maryland, 21231, United States

Location

Related Publications (1)

  • 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.

    PMID: 26684478DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Erica Sibinga, MD, MHS

    Johns Hopkins School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2015

First Posted

July 9, 2015

Study Start

October 1, 2012

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

January 18, 2018

Record last verified: 2018-01

Locations

US(3)