An interventional study of Parent-implemented Early Start Denver Model and Mindfulness Based Stress Reduction in Autism Spectrum Disorder, Parents and Stress, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 12 Months and older. Per ClinicalTrials.gov, last updated 2019-03-26.
Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Treatment
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.
1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.
This study's enrollment of 63 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.
Browse Autistic Disorder studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM).
Behavioral: Parent-implemented Early Start Denver Model
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).
Behavioral: Parent-implemented Early Start Denver Model · Behavioral: Mindfulness Based Stress Reduction
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.
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.
Change in parental stress
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 typical, and ranks of 81 and above are considered high.
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental depression
Parents completed the Beck Depression Inventory (BDI; Beck et al., 1984). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology.
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental anxiety
Parents completed the Beck Anxiety Inventory (BAI; Beck et al., 1988). This instrument consists of 21 items, with higher scores reflecting higher levels of symptomatology.
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental mindfulness
. Parents completed the Five Facet Mindfulness Questionnaire (FFMQ; Baer et al., 2006). The FFMQ consists of 44 items that yield five subscales: Observing, Describing, Acting with Awareness, Nonreactivity, and Nonjudging. Higher scores indicate more mindfulness.
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Change in parent relationship quality
The Dyadic Adjustment Scale (DAS; Spanier, 1989) is a 32-item measure that assesses relationship satisfaction. It includes four subscales scored using a mix of Likert and dichotomous responses. Higher scores indicate higher relationship satisfaction.
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental life satisfaction
Parents completed the Satisfaction with Life Scale (SLS; Diener et al., 1984). The SLS is a 5-item measure of subjective wellbeing, with each item scored along a 7-point Likert scale (higher scores indicate more satisfaction).
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Change in parental sleep quality
Parents completed the Insomnia Severity Index (ISI; Bastien et al., 2011). The ISI consists of seven items scored from 0-4, with higher scores reflecting more sleep-related impairment.
Time frame: Baseline to end of study (Every 6 weeks for 9 months)
Change in child autism symptom severity
The Autism Diagnostic Observation Schedule - Second Edition (ADOS-2; Lord et al., 2012) is a standardized clinical observation system for use with people with developmental ages of 12 months and older. Each child completes one module based upon age and language level. This module yields a Calibrated Severity Scores (CSS; range: 1-10). Higher scores reflect higher levels of autism symptoms.
Time frame: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child cognitive functioning
The Mullen Scales of Early Learning (MSEL; Mullen, 1995) is a standardized developmental test for children up to age five years.57 It provides scores in four domains (Visual Reception, Fine Motor, Receptive Language, Expressive Language; M=50, SD=10) and yields an overall ability index termed the Early Learning Composite (ELC; M=100, SD=15). Higher scores reflect higher levels of abilities relative to same-aged peers.
Time frame: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child adaptive behavior
The Vineland Adaptive Behavior Scales - Second Edition (VABS-II; Sparrow et al., 1985), Interview Form is a semistructured interview. It yields four domain standard scores: Communication, Daily Living Skills, Socialization, and Motor Skills (M = 100, SD = 15) as well as an overall Adaptive Behavior Composite (M = 100, SD = 15). High scores reflect better developed adaptive behavior skills.
Time frame: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child problem behaviors
The Achenbach Child Behavior Checklist (CBCL; Achenbach, 2001) yields Internalizing, Externalizing, and Total Problem composite scores. Scores are reported as T scores, with T scores above 65 reflecting clinical significance.
Time frame: Baseline, end of treatment (12 weeks), end of study (9 months)
Change in child communication behaviors
The MacArthur CDI Words and Gestures (Fenson et al., 2006) provides a count of parent-reported phrases understood, vocabulary comprehension and production, and actions and gestures. Higher scores indicate more reported language skills.
Time frame: Baseline, end of treatment (12 weeks), end of study (9 months)
Plan to share: Yes — Data sharing procedures will adhere to guidelines established by the NIH sponsored National Database for Autism Research (NDAR). NDAR is a scalable informatics platform for ASD relevant data. NDAR was developed to share data and facilitate collaboration across the ASD field. We will participate in this system for sharing data in hopes that such sharing will accelerate research progress by allowing re-analysis of data, as well as re-aggregation, integration, and rigorous comparison with other data, tools, and methods. We will submit both descriptive and experimental data (http://ndar.nih.gov/).
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Vanderbilt University Medical Center