Clinical Trials Directory

Trials / Completed

CompletedNCT03889821

Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
63 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
12 Months
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALParent-implemented Early Start Denver ModelThe 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.
BEHAVIORALMindfulness Based Stress ReductionThe 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.

Timeline

Start date
2015-03-11
Primary completion
2018-03-23
Completion
2018-03-23
First posted
2019-03-26
Last updated
2019-03-26

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03889821. Inclusion in this directory is not an endorsement.