CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 63 enrolled
Drug / intervention
Parent-implemented Early Start Denver Model +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03889821
NCT03889821N/ACompleted

Does Mindfulness Training Enhance Early Evidence-based Parent-coaching Interventions for Autism Spectrum Disorder?: A Randomized Controlled Trial

Vanderbilt University Medical Center·interventional·Posted Mar 26, 2019·Updated Mar 26, 2019

In Brief

A clinical study evaluating Parent-implemented Early Start Denver Model and Mindfulness Based Stress Reduction for Autism Spectrum Disorder and 2 related conditions. Completed, enrolled 63 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedMar 26, 2019
Enrollment StartMar 11, 2015
Primary CompletionMar 23, 2018
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 7.3 years ago

Interventions

Parent-implemented Early Start Denver Modelbehavioral

The Parent-implemented Early Start Denver Model (P-ESDM; Rogers et al., 2012) consists of 12 consecutive sessions, each session approximately 1 hour long, that promote parental ability to support and interact with their young children with autism spectrum disorder (ASD). Intervention sessions are conducted in the clinic setting by therapists trained to fidelity by ESDM-certified parent trainers. The manualized intervention has a detailed parent-training curriculum, a specific coaching intervention method, and a therapist fidelity measure. Therapists introduce skills through descriptions, interaction, modeling, coaching, and feedback.

Mindfulness Based Stress Reductionbehavioral

The Mindfulness Based Stress Reduction (MBSR) protocol is derived from the work by Dykens et al. (2014), which is based on the stress reduction and relaxation program (Kabat-Zinn, 1982, 1990). In this study, it is offered as 6 weekly sessions that run concurrent with the P-ESDM intervention. Participants work one-on-one with a therapist for instruction and practice in mindfulness skills as well as discussions of stress, coping, and homework assignments.