Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder

Not Applicable

Completed

• Conditions: Parents; Stress; Autism Spectrum Disorder
• Interventions: Behavioral: Parent-implemented Early Start Denver Model; Behavioral: Mindfulness Based Stress Reduction

• Registration Number: NCT03889821
• Lead Sponsor: Vanderbilt University Medical Center

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-03-11
• Primary Completion: 2018-03-23
• Study Completion: 2018-03-23
• Status Verified: 2019-03
• Study First Submitted: 2019-03-20
• Study First Submitted QC: 2019-03-21
• Last Update Submitted: 2019-03-21
• Study First Posted: 2019-03-26
• Last Update Posted: 2019-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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

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Exclusion Criteria

• Severe child sensorimotor impairment that would impact participation in treatment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Child- and Parent-focused Treatment	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).
Child-focused Treatment	Parent-implemented Early Start Denver Model	Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM).
Child- and Parent-focused Treatment	Mindfulness Based Stress Reduction	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).

Primary Outcome Measures

Name	Time	Method
Change in parent relationship quality	Baseline to end of study (Every 6 weeks for 9 months)	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.
Change in parental sleep quality	Baseline to end of study (Every 6 weeks for 9 months)	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.
Change in parental stress	Baseline to end of study (Every 6 weeks for 9 months)	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.
Change in parental depression	Baseline to end of study (Every 6 weeks for 9 months)	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.
Change in parental anxiety	Baseline to end of study (Every 6 weeks for 9 months)	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.
Change in parental mindfulness	Baseline to end of study (Every 6 weeks for 9 months)	. 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.
Change in parental life satisfaction	Baseline to end of study (Every 6 weeks for 9 months)	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).

Secondary Outcome Measures

Name	Time	Method
Change in child autism symptom severity	Baseline, end of treatment (12 weeks), end of study (9 months)	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.
Change in child adaptive behavior	Baseline, end of treatment (12 weeks), end of study (9 months)	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.
Change in child problem behaviors	Baseline, end of treatment (12 weeks), end of study (9 months)	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.
Change in child cognitive functioning	Baseline, end of treatment (12 weeks), end of study (9 months)	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.
Change in child communication behaviors	Baseline, end of treatment (12 weeks), end of study (9 months)	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States