Clinical trial NCT03633903: Mindfulness for Resilience in Early Life
Official title: Mindfulness for Resilience in Early Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent With Early Life Stress
Resilience
Keywords: Early life stress
Adolescent
Mindfulness
Neurobiological
Stress
Resilience
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
Collaborators: name: Oklahoma State University
First posted: 2018-08-16
Enrollment: 40
Sex: ALL
Minimum age (years): 13
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Adolescents are randomly assigned to either a mindfulness intervention or no intervention.
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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)

Primary outcomes:
measure: Cortisol Reactivity
timeFrame: Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline
measure: Immune System Activity
timeFrame: Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline
Secondary outcomes:
measure: Mood and Feelings Questionnaire
timeFrame: Baseline (pre-intervention); Follow-up (post-intervention) at 6-8 weeks from baseline
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Namik Kirlic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cohen ZP, Cosgrove KT, Akeman E, Coffey S, Teague K, Hays-Grudo J, Paulus MP, Aupperle RL, Kirlic N. The effect of a mindfulness-based stress intervention on neurobiological and symptom measures in adolescents with early life stress: a randomized feasibility study. BMC Complement Med Ther. 2021 Apr 15;21(1):123. doi: 10.1186/s12906-021-03295-1.