- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01592188
Cognitively-Based Compassion Training and Mindfulness Attention Training Program
November 13, 2013 updated by: Thaddeus Pace, PhD, Emory University
Cognitively-Based Compassion Training and Mindfulness Attention Training for Elementary School Students
This project will explore the effect of Cognitively-Based Compassion Training or mindfulness training on behavior and saliva stress hormones in elementary school-age children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This project will explore the effect of Cognitively-Based Compassion Training (CBCT) or mindfulness training (MT) on different aspects of behavior and stress-related biology in elementary school-age children.
The program will consist of 12 weeks of CBCT or MT, and various social behavioral assessments will be conducted.
Participants will also provide saliva in which concentrations of stress hormones including cortisol and the inflammatory biomarkers C-reactive protein will be measured.
Study Type
Interventional
Enrollment (Actual)
53
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Atlanta, Georgia, United States, 30307
- Paideia School
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- age 7-12
- enrollment at the Paideia School.
Exclusion Criteria:
- poor physical health
- enrollment at a school other than the Paideia school.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: MT
Mindfulness training.
Participants will be provided with once per week training in mindfulness meditation.
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Mindfulness training will consist of 6 weeks training in mindfulness meditation.
Other Names:
|
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Experimental: CBCT
Cognitively-based compassion training.
Participants in this arm will be provided with once weekly training on the cognitively-based compassion training program.
|
CBCT is a 12 week program that begins by teaching mindfulness and attention.
It then goes on to use new mindfulness skills to consider topics of compassion, or unbiased acceptance and compassion for all other people, both friends, unfamiliar people, and enemies.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interpersonal behaviors assessed using standardized protocols of social behavior, social cognition, and empathy.
Time Frame: 12 weeks
|
Assessments before and after CBCT or MT interventions will be conducted to see if these practices lead to changes in interpersonal behavior.
Participants will be asked to respond to questions related to social behavior in the lab setting, with the Social Circle Task, Mind In The Eyes Task, and the Implicit Association Task.
|
12 weeks
|
|
Concentrations of stress system biomarkers in saliva
Time Frame: 12 weeks
|
Assessments before and after CBCT or MT interventions will be conducted to see if these practices lead to changes in stress system activity, as measured by key biomarkers (cortisol, C-reactive protein) in saliva samples.
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12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Philippe Rochat, PhD, Emory University
- Principal Investigator: Thaddeus Pace, PhD, Emory University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
May 2, 2012
First Submitted That Met QC Criteria
May 3, 2012
First Posted (Estimate)
May 7, 2012
Study Record Updates
Last Update Posted (Estimate)
November 14, 2013
Last Update Submitted That Met QC Criteria
November 13, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- IRB00054782
- CBCT-Paideia (Other Identifier: Other)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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