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Clinical Trials/NCT02222662
NCT02222662
Completed
Not Applicable

Phase 1 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism Ages 6 to 11

Western Oregon University1 site in 1 country35 target enrollmentJune 2014
ConditionsAutism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Western Oregon University
Enrollment
35
Locations
1
Primary Endpoint
Change in severity of autism
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
June 2014
End Date
February 2016
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Louisa Silva

Principal Investigator, Visiting Professor

Western Oregon University

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Change in severity of autism

Time Frame: 5 months and one year

The Childhood Autism Rating Scales will be used to measure this.

Secondary Outcomes

  • Change in developmental skills(5 months and one year)

Study Sites (1)

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