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Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder, Parents, Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent-implemented Early Start Denver Model
Mindfulness Based Stress Reduction
Sponsored by
Vanderbilt University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism Spectrum Disorder

Eligibility Criteria

12 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Child-focused Treatment

Child- and Parent-focused Treatment

Arm Description

Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM).

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).

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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).
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 20, 2019
Last Updated
March 21, 2019
Sponsor
Vanderbilt University Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03889821
Brief Title
Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder
Official Title
Does Mindfulness Training Enhance Early Evidence-based Parent-coaching Interventions for Autism Spectrum Disorder?: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 11, 2015 (Actual)
Primary Completion Date
March 23, 2018 (Actual)
Study Completion Date
March 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Parents, Stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
63 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Child-focused Treatment
Arm Type
Active Comparator
Arm Description
Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM).
Arm Title
Child- and Parent-focused Treatment
Arm Type
Experimental
Arm 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).
Intervention Type
Behavioral
Intervention Name(s)
Parent-implemented Early Start Denver Model
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Stress Reduction
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in parental stress
Description
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)
Title
Change in parental depression
Description
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)
Title
Change in parental anxiety
Description
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)
Title
Change in parental mindfulness
Description
. 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)
Title
Change in parent relationship quality
Description
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)
Title
Change in parental life satisfaction
Description
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)
Title
Change in parental sleep quality
Description
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)
Secondary Outcome Measure Information:
Title
Change in child autism symptom severity
Description
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)
Title
Change in child cognitive functioning
Description
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)
Title
Change in child adaptive behavior
Description
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)
Title
Change in child problem behaviors
Description
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)
Title
Change in child communication behaviors
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy S Weitlauf, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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/).
Citations:
Citation
Abidin, R. (1995). Parenting Stress Index, 3rd Edition. Lutz, FL: Psychological Assessment Resources.
Results Reference
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Citation
Achenbach, T. M. (2001). Achenbach Child Behavior Checklist. Burlington, VT: ASEBA.
Results Reference
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PubMed Identifier
16443717
Citation
Baer RA, Smith GT, Hopkins J, Krietemeyer J, Toney L. Using self-report assessment methods to explore facets of mindfulness. Assessment. 2006 Mar;13(1):27-45. doi: 10.1177/1073191105283504.
Results Reference
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PubMed Identifier
3204199
Citation
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
Results Reference
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Citation
Beck AT, Steer RA., Brown GK . Manual for the Beck Depression Inventory-II. 1996. San Antonio: Psychological Corporation.
Results Reference
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PubMed Identifier
11438246
Citation
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
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PubMed Identifier
16367493
Citation
Diener E, Emmons RA, Larsen RJ, Griffin S. The Satisfaction With Life Scale. J Pers Assess. 1985 Feb;49(1):71-5. doi: 10.1207/s15327752jpa4901_13.
Results Reference
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PubMed Identifier
25049350
Citation
Dykens EM, Fisher MH, Taylor JL, Lambert W, Miodrag N. Reducing distress in mothers of children with autism and other disabilities: a randomized trial. Pediatrics. 2014 Aug;134(2):e454-63. doi: 10.1542/peds.2013-3164. Epub 2014 Jul 21.
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Citation
Fenson, L., Marchman, V., Thal, D., Dale, P., Reznick, S., & Bates, E. (2006). The MacArthur Communicative Development Inventories: User's guide and technical manual (2nd ed.). Baltimore: Brookes.
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Kabat-Zinn J. An outpatient program in behavioral medicine for chronic pain patients based on the practice of mindfulness meditation: theoretical considerations and preliminary results. Gen Hosp Psychiatry. 1982 Apr;4(1):33-47. doi: 10.1016/0163-8343(82)90026-3.
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Kabat-Zinn, J. (1990). Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. New York: Dell Publishing.
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Lord, C., Rutter, M., DiLavore, P., Risi, S., Gotham, K., & Bishop, S.L. (2012). Autism Diagnostic Observation Schedule, 2nd edition (ADOS-2): Manual. Los Angeles: Western Psychological Services.
Results Reference
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Mullen, E. M. (1994). Mullen Scales of Early Learning. Circle Pines, MN: American Guidance Service.
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Citation
Rogers SJ, Estes A, Lord C, Vismara L, Winter J, Fitzpatrick A, Guo M, Dawson G. Effects of a brief Early Start Denver model (ESDM)-based parent intervention on toddlers at risk for autism spectrum disorders: a randomized controlled trial. J Am Acad Child Adolesc Psychiatry. 2012 Oct;51(10):1052-65. doi: 10.1016/j.jaac.2012.08.003. Epub 2012 Aug 28.
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Citation
Weitlauf AS, Broderick N, Stainbrook JA, Taylor JL, Herrington CG, Nicholson AG, Santulli M, Dykens EM, Juarez AP, Warren ZE. Mindfulness-Based Stress Reduction for Parents Implementing Early Intervention for Autism: An RCT. Pediatrics. 2020 Apr;145(Suppl 1):S81-S92. doi: 10.1542/peds.2019-1895K.
Results Reference
derived

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Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder

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