Clinical trial NCT03889821: 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
Overall status: COMPLETED
Phase: NA
Conditions: Autism Spectrum Disorder
Parents
Stress
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2019-03-26
Enrollment: 63
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in parental stress
timeFrame: Baseline to end of study (Every 6 weeks for 9 months)
measure: Change in parental depression
timeFrame: Baseline to end of study (Every 6 weeks for 9 months)
measure: Change in parental anxiety
timeFrame: Baseline to end of study (Every 6 weeks for 9 months)
measure: Change in parental mindfulness
timeFrame: Baseline to end of study (Every 6 weeks for 9 months)
measure: Change in parent relationship quality
timeFrame: Baseline to end of study (Every 6 weeks for 9 months)
measure: Change in parental life satisfaction
timeFrame: Baseline to end of study (Every 6 weeks for 9 months)
measure: Change in parental sleep quality
timeFrame: Baseline to end of study (Every 6 weeks for 9 months)
Secondary outcomes:
measure: Change in child autism symptom severity
timeFrame: Baseline, end of treatment (12 weeks), end of study (9 months)
measure: Change in child cognitive functioning
timeFrame: Baseline, end of treatment (12 weeks), end of study (9 months)
measure: Change in child adaptive behavior
timeFrame: Baseline, end of treatment (12 weeks), end of study (9 months)
measure: Change in child problem behaviors
timeFrame: Baseline, end of treatment (12 weeks), end of study (9 months)
measure: Change in child communication behaviors
timeFrame: Baseline, end of treatment (12 weeks), end of study (9 months)
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Amy S Weitlauf, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Abidin, R. (1995). Parenting Stress Index, 3rd Edition. Lutz, FL: Psychological Assessment Resources.
citation: Achenbach, T. M. (2001). Achenbach Child Behavior Checklist. Burlington, VT: ASEBA.
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.
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.
citation: Beck AT, Steer RA., Brown GK . Manual for the Beck Depression Inventory-II. 1996. San Antonio: Psychological Corporation.
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.
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.
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.
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.
citation: 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.
citation: Kabat-Zinn, J. (1990). Full Catastrophe Living: Using the Wisdom of your Mind to Face Stress, Pain and Illness. New York: Dell Publishing.
citation: 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.
citation: Mullen, E. M. (1994). Mullen Scales of Early Learning. Circle Pines, MN: American Guidance Service.
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.
citation: Spanier, G.B. (1989). Manual for the Dyadic Adjustment Scale. North Tonowanda, NY: Multi-Health Systems.
citation: Sparrow, S. D., Cicchetti, D. V., & Balla, D. A. (2005). Vineland-II Adaptive Behavior Scales: Survey Forms Manual. Circle Pines, MN: AGS Publishing.
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.