Parent-delivered Massage for Children With Autism – Ages 6 to 11

Overview

Through funding from the U.S. Maternal and Child Health Bureau, Teaching Research Institute at Western Oregon University (WOU) will be conducting research on the effect of a parent-delivered massage program on measures of autism and general development in children ages 6 to 11 with autism. Families will participate in an initial training, and receive 24 sessions of ongoing support and training from a trained therapist over the first nine months.

Full Title of Study: “Phase 1 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism Ages 6 to 11”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: February 2016

Detailed Description

Children will be randomly divided into treatment groups and wait-list control groups. The control groups begin treatment five months after the treatment groups begin. All children will be tested on three occasions in the first year: prior to beginning treatment, and five and twelve months later. Results will be shared with parents at the end of each year. Testers will remain blinded as to which group is currently receiving treatment. There is no cost to parents for participation in this research study. Families meeting the eligibility criteria will be accepted into the study on a first-come, first-served basis.

Interventions

  • Other: Parent massage tx group
    • The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
  • Other: Parent massage wait-list control group
    • The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.

Arms, Groups and Cohorts

  • Experimental: Parent massage tx group
    • Children in this group receive the parent-delivered massage intervention right after randomization.
  • Experimental: Parent massage wait-list control group
    • Children in this group receive the parent-delivered massage intervention 5 months after randomization.

Clinical Trial Outcome Measures

Primary Measures

  • Change in severity of autism
    • Time Frame: 5 months and one year
    • The Childhood Autism Rating Scales will be used to measure this.

Secondary Measures

  • Change in developmental skills
    • Time Frame: 5 months and one year
    • The Vineland II will be used to measure this.

Participating in This Clinical Trial

Inclusion Criteria

  • Have a medical and/or educational diagnosis of autism – Be between the age of 6 and 11 – Parents willing to attend the parent training session and transport the child to treatment sessions with trained staff 20 times in the first five months – Parents willing to give the fifteen-minute massage daily – Parents willing not to start any new interventions unless medically necessary Exclusion Criteria:

  • Taking psychoactive medication or pharmaceutical chelation therapy – Additional chronic disability (for example, cerebral palsy or uncontrolled seizures) – Receiving more than fifteen hours per week of intensive behavioral treatment for autism (e.g. Applied Behavior Analysis therapy)

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: 11 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Western Oregon University
  • Collaborator
    • HRSA/Maternal and Child Health Bureau
  • Provider of Information About this Clinical Study
    • Principal Investigator: Louisa Silva, Principal Investigator, Visiting Professor – Western Oregon University
  • Overall Official(s)
    • Louisa Silva, MD MPH, Principal Investigator, Western Oregon University

References

Silva LM, Schalock M, Ayres R, Bunse C, Budden S. Qigong massage treatment for sensory and self-regulation problems in young children with autism: a randomized controlled trial. Am J Occup Ther. 2009 Jul-Aug;63(4):423-32. doi: 10.5014/ajot.63.4.423.

Silva L, Schalock M. Treatment of tactile impairment in young children with autism: results with qigong massage. Int J Ther Massage Bodywork. 2013 Dec 3;6(4):12-20. doi: 10.3822/ijtmb.v6i4.227. eCollection 2013.

Silva LM, Schalock M, Gabrielsen K. Early intervention for autism with a parent-delivered Qigong massage program: a randomized controlled trial. Am J Occup Ther. 2011 Sep-Oct;65(5):550-9. doi: 10.5014/ajot.2011.000661.

Silva LM, Schalock M, Ayres R. A model and treatment for autism at the convergence of Chinese medicine and Western science: first 130 cases. Chin J Integr Med. 2011 Jun;17(6):421-9. doi: 10.1007/s11655-011-0635-0. Epub 2011 Jun 10.

Silva LM, Schalock M, Gabrielsen KR, Budden SS, Buenrostro M, Horton G. Early Intervention with a Parent-Delivered Massage Protocol Directed at Tactile Abnormalities Decreases Severity of Autism and Improves Child-to-Parent Interactions: A Replication Study. Autism Res Treat. 2015;2015:904585. doi: 10.1155/2015/904585. Epub 2015 Mar 24.

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