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Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03889821
Recruitment Status : Completed
First Posted : March 26, 2019
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Amy Weitlauf, Vanderbilt University Medical Center

Tracking Information
First Submitted Date  ICMJE March 20, 2019
First Posted Date  ICMJE March 26, 2019
Last Update Posted Date March 26, 2019
Actual Study Start Date  ICMJE March 11, 2015
Actual Primary Completion Date March 23, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Change in parental stress [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 parent relationship quality [ Time Frame: 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 life satisfaction [ Time Frame: 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).
  • Change in parental sleep quality [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)
  • Change in child autism symptom severity [ Time Frame: 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 cognitive functioning [ Time Frame: 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 adaptive behavior [ Time Frame: 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 [ Time Frame: 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 communication behaviors [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness Training and Parent-coaching Interventions for Autism Spectrum Disorder
Official Title  ICMJE Does Mindfulness Training Enhance Early Evidence-based Parent-coaching Interventions for Autism Spectrum Disorder?: A Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Autism Spectrum Disorder
  • Parents
  • Stress
Intervention  ICMJE
  • Behavioral: Parent-implemented Early Start Denver Model
    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.
  • Behavioral: Mindfulness Based Stress Reduction
    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.
Study Arms  ICMJE
  • Active Comparator: Child-focused Treatment
    Participants in this group participate in 12 sessions of the Parent-implemented Early Start Denver Model (P-ESDM).
    Intervention: Behavioral: Parent-implemented Early Start Denver Model
  • Experimental: Child- and Parent-focused Treatment
    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).
    Interventions:
    • Behavioral: Parent-implemented Early Start Denver Model
    • Behavioral: Mindfulness Based Stress Reduction
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 21, 2019)
63
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 23, 2018
Actual Primary Completion Date March 23, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03889821
Other Study ID Numbers  ICMJE MBSR and P-ESDM
R40MC30769 ( Other Grant/Funding Number: Health Resources and Services Administration )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
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/).
Current Responsible Party Amy Weitlauf, Vanderbilt University Medical Center
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Vanderbilt University Medical Center
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Amy S Weitlauf, PhD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP