Abstract
This randomized controlled trial (NCT03889821) examined Mindfulness Based Stress Reduction (MBSR) in conjunction with the Parent-implemented Early Start Denver Model (P-ESDM). A previous report described improved metrics of parental distress (Weitlauf et al. in Pediatrics 145(Supplement 1):S81–S92, 2020). This manuscript examines child outcomes. 63 children with ASD (< 36 months) and their parents received 12 P-ESDM sessions. Half of parents also received MBSR. Longitudinal examination of whole sample means revealed modest improvements in autism severity, cognitive, and adaptive skills. There was not a significant time × group interaction for children whose parents received MBSR. Future work should examine more proximal markers of child or dyadic change to enhance understanding of the impact of providing direct treatment for parents as part of early intervention initiatives.
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All phases of this study were supported by the Health Resources & Services Administration Maternal & Child Health Bureau, R40MC27706. Study design and implementation received core support from the Eunice Kennedy Shriver National Institute of Child Health and Human Development (U54 HD08321) and the Vanderbilt Institute for Clinical and Translational Research (VICTR), which is funded by the National Center for Advancing Translational Sciences (NCATS) Clinical Translational Science Award (CTSA) Program, Award Number 5UL1TR002243-03.
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ASW, NB, CGH, EMD, JLT, JAS, and ZEW conceptualized the study design, including modification of existing MBSR protocols. JLT and JCS provided statistical consultation and analytic support. ASW, AGN, JAS, and APJ provided personnel supervision. AGN, JAS, and MS coordinated key aspects of study implementation, including participant recruitment and evaluation as well as data collection. NB, CGH, AGN, KD, LJG, JAS, MM, AK, and AV provided direct therapeutic support to children and families. ASW, JCS, NB, and ZEW held primary responsibility for final manuscript completion.
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This trial has been registered at www.clinicaltrials.gov (identifier NCT03889821). All procedures performed in this study were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. All procedures were approved and overseen by the Vanderbilt University Medical Center Institutional Review Board.
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Weitlauf, A.S., Broderick, N., Alacia Stainbrook, J. et al. A Longitudinal RCT of P-ESDM With and Without Parental Mindfulness Based Stress Reduction: Impact on Child Outcomes. J Autism Dev Disord 52, 5403–5413 (2022). https://doi.org/10.1007/s10803-021-05399-6
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DOI: https://doi.org/10.1007/s10803-021-05399-6