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NCT03633903 · ClinicalTrials.gov registry record · NA

Mindfulness for Resilience in Early Life

A NA study, sponsored by Laureate Institute for Brain Research.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT03633903: Completed NA study, sponsored by Laureate Institute for Brain Research.

NCT03633903 is a NA study that has completed, run by Laureate Institute for Brain Research. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03633903, a NA study, has completed, sponsored by Laureate Institute for Brain Research.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

Study 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 regulat

Primary Outcome

Change in level of cortisol in saliva following a social stress test. Subjects completed the Trier Social Stress Test for Children (TSST-C) at baseline and follow-up. The TSST-C consists of public speaking and serial subtraction components in front of two research confederates. The test takes approximately 20 minutes to complete. Salivary cortisol was collected 20 minutes prior to TSST-C, and 20 minutes following the end of the TSST-C, such that the TSST-C task with data collection spanned appro

Interventions

  • BEHAVIORAL Mindfulness

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-07-12
Est. Completion 2019-03-07
Phase NA

What the finished NCT03633903 record still lists

NCT03633903 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 1 intervention - of which Mindfulness is the first listed.

NCT03633903 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03633903 about?

NCT03633903 is a clinical study titled "Mindfulness for Resilience in Early Life". 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 fo...

What is the current status of trial NCT03633903?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2018-07-12. Estimated completion is 2019-03-07.

What interventions are being tested in trial NCT03633903?

The interventions under investigation include: Mindfulness (BEHAVIORAL).

Who is sponsoring clinical trial NCT03633903?

This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03633903's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03633903, the US trial registry maintained by the National Library of Medicine. NCT03633903 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.