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NCT03889821 · ClinicalTrials.gov registry record · NA

Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder

A NA study, sponsored by Vanderbilt University Medical Center.

Completed
Registry status
NA
Development phase
63
Enrollment target

NCT03889821: Completed NA study, sponsored by Vanderbilt University Medical Center.

NCT03889821 is a NA study that has completed, run by Vanderbilt University Medical Center. The registered enrollment target is 63 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03889821, a NA study, has completed, sponsored by Vanderbilt University Medical Center.

COMPLETED
Registry status
NA
Development phase
63 participants
Enrollment target

Study Summary

Caregivers of children with autism spectrum disorder (ASD) report higher levels of depression and distress than caregivers of typically developing children as well as children with other developmental disabilities. The proposed work tests a novel treatment paradigm that blends Mindfulness Based Stress Reduction (MBSR) with an empirically supported and manualized parent training program (Parent-Implemented Early Start Denver Model \[P-ESDM\]). We hypothesize that directly treating parental distress, while simultaneously providing evidence-based parent training, may greatly enhance child-focused intervention and provide benefits that resonate across the family.

Primary Outcome

The Parenting Stress Index - Short Form, Third Edition (PSI-SF; Abidin, 1995), is a 36-item measure that yields three subscale scores (Parent Child Dysfunctional Interaction, Parenting Distress, Difficult Child) used in present analyses. Each item is rated as by parents as: SA (strongly agree), A (agree), NS (not sure), D (disagree), SD (strongly disagree). Scores are converted to percentile ranks, with higher scores indicating higher levels of stress. Percentile ranks of 15-80 considered typica

Interventions

  • BEHAVIORAL Mindfulness Based Stress Reduction
  • BEHAVIORAL Parent-implemented Early Start Denver Model

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2015-03-11
Est. Completion 2018-03-23
Phase NA

What the finished NCT03889821 record still lists

NCT03889821 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 63 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 2 interventions - of which Mindfulness Based Stress Reduction is the first listed.

NCT03889821 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03889821 about?

NCT03889821 is a clinical study titled "Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder". Caregivers of children with autism spectrum disorder (ASD) report higher levels of depression and distress than caregivers of typically developing children as well as children with other developmental disabilities. The proposed work tests a novel treatment paradigm that blends Mindfulness Based Stre...

What is the current status of trial NCT03889821?

This trial is currently completed. It is a NA study. The enrollment target is 63 participants. The study started on 2015-03-11. Estimated completion is 2018-03-23.

What interventions are being tested in trial NCT03889821?

The interventions under investigation include: Mindfulness Based Stress Reduction (BEHAVIORAL), Parent-implemented Early Start Denver Model (BEHAVIORAL).

Who is sponsoring clinical trial NCT03889821?

This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03889821's enrollment target sits among peer trials

63 1157th of 2000 higher than 844 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 NCT03889821, the US trial registry maintained by the National Library of Medicine. NCT03889821 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.