Mindfulness for Resilience in Early Life



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:13 - 15
Updated:8/18/2018
Start Date:July 12, 2018
End Date:June 1, 2019
Contact:Namik Kirlic, PhD
Email:nkirlic@laureateinstitute.org
Phone:918-502-5100

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Early life stress (ELS) is associated with a number of psychiatric and medical conditions
later in life, thought to be caused by subsequent disruptions in biological processes
involved in regulation of stress responses. Given that these alterations have long-lasting
effects, there is a great need for effective preventative interventions. The long-term goal
of this project is to identify early interventions that may most powerfully mitigate risk for
psychiatric illness among adolescents with exposure to early life stress (ELS), with a focus
on interventions that can be widely and effectively implemented, have the potential for
long-lasting benefits, and can effectively engage targeted neurobiological processes and
networks. The specific aims of the present study are to 1) examine how ELS impacts biological
processes associated with regulation of stress, and 2) identify how MBI impacts affective
symptoms and biological processes dysregulated by ELS.

This study supports the efforts to reduce the effects of early adversity in children by
testing an impact of an effective psychological intervention on disrupted biological
processes caused by early adversity. Successful achievement of the proposed aims will
contribute to a) the knowledge base needed to reduce the effects of trauma and stress in
children and families and b) the development of easily implemented and disseminated
preventative interventions.

The proposed study will utilize a multi-method design to examine the effect of mindfulness on
biological processes (i.e., stress responses) disrupted by exposure to ELS among adolescents
age 13 to 15. Adolescents will first complete self-report measures of childhood adverse
experiences, trauma, and neglect. Forty eligible adolescents will be next randomly assigned
to either an eight session mindfulness-based stress reduction intervention for teens or no
treatment. Pre- and post-intervention assessment will include (a) self-report measures of
symptoms and emotion regulation, (b) a blood draw for assessment of inflammatory markers and
gene expression, and (c) a stress task with saliva cortisol collected before and after this
task.


Inclusion Criteria:

- Age 13.00 to 15.99 years at time of baseline assessment

- Able to validly and safely complete baseline assessments

- All genders

- All races

- Eligibility as a subject with early life stress will be determined by:

- Scoring 4 or greater on Adverse Childhood Experiences (ACE) scale, with at least two
experiences having occurred prior to age 10.

Exclusion Criteria:

- No biological parent or legal guardian identified to give permission for minor to
participate

- History of neurological disorders including seizure disorder, cerebral palsy, or other
conditions requiring neurological or medical care, being managed for migraines (e.g.,
daily prophylactic medication, seeing a neurologist for migraines), or a diagnosis of
Developmental Delay, including severe learning disorder, mental retardation, pervasive
developmental disorder, or other conditions requiring repeated and persistent
specialized education.

- Current psychotic disorder, bipolar disorder, obsessive-compulsive and related
disorders, substance use disorder, or conduct disorder.

- Current active suicidal ideation.

- Current use of medications with major effects on brain function or blood flow (e.g.,
antipsychotics, mood stabilizers); ADHD medications and SSRIs, that have been stable
for at least 6 weeks, are not exclusionary since their use is associated with
conditions that confer risk for monitored disorders that emerge in adolescence, and
assessment of these individuals will provide useful data to the scientific community.
Youth on ADHD medications and SSRIs will not be asked to go off their medications.

- Not fluent in English

- Non-correctable vision, hearing or sensorimotor impairments, as protocol elements may
not be valid.

- Youth planning to move to an area not within reasonable traveling distance of LIBR;
knowledge at baseline that treatment completion / follow-up will not be possible.

- Youth appears to be high/intoxicated, or withdrawing from the effects of alcohol or
drugs at time of enrollment.

- Youth / parent who are unable or unwilling to provide biological samples (i.e., blood
draws or saliva collection).

- Female youth who are pregnant

- Youth who are currently in unsafe environments (e.g., currently living with an abusive
parent)
We found this trial at
1
site
Tulsa, Oklahoma 74136
Principal Investigator: Namik Kirlic, PhD
Phone: 918-502-5180
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mi
from
Tulsa, OK
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