Mindfulness for Resilience in Early Life

NCT ID: NCT03633903

Last Updated: 2021-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2019-03-07

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.

Conditions

Adolescent With Early Life Stress; Resilience

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Mindfulness

Mindfulness: Eight sessions, twice per week over four weeks. Surveys administered prior to each session.

Group Type: ACTIVE_COMPARATOR

Mindfulness

Intervention Type: BEHAVIORAL

Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience

Control

Treatment as usual (i.e., pharmacotherapy, psychotherapy, etc.) for the four week duration with twice weekly surveys administered.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness

Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Oklahoma State University

OTHER

Sponsor Role: collaborator

Laureate Institute for Brain Research, Inc.

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Namik Kirlic, PhD

Role: PRINCIPAL_INVESTIGATOR

Laureate Institute for Brain Research

Locations

Laureate Institute for Brain Research

Tulsa, Oklahoma, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33858395 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

LIBR # 2018-003-00

Identifier Type: -

Identifier Source: org_study_id