ClinicalTrials.Veeva

Menu

Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder

Vanderbilt University Medical Center logo

Vanderbilt University Medical Center

Status

Completed

Conditions

Autism Spectrum Disorder
Parents
Stress

Treatments

Behavioral: Parent-implemented Early Start Denver Model
Behavioral: Mindfulness Based Stress Reduction

Study type

Interventional

Funder types

Other

Identifiers

NCT03889821
MBSR and P-ESDM
R40MC30769 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

63 patients

Sex

All

Ages

12+ months old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Child has diagnosis of autism spectrum disorder
  • Child at least 12 months of age but less than 36 months at time of consent
  • Parent speaks and reads fluent English

Exclusion criteria

  • Severe child sensorimotor impairment that would impact participation in treatment

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

63 participants in 2 patient groups

Child-focused Treatment
Active Comparator group
Description:
Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM).
Treatment:
Behavioral: Parent-implemented Early Start Denver Model
Child- and Parent-focused Treatment
Experimental group
Description:
Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM). Parents also participate in 6 separate, individual sessions of Mindfulness Based Stress Reduction (MBSR).
Treatment:
Behavioral: Parent-implemented Early Start Denver Model
Behavioral: Mindfulness Based Stress Reduction

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2026 Veeva Systems