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

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parent massage tx group
Parent massage wait-list control group
Sponsored by
Western Oregon University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring Massage, effectiveness, autism, parent stress

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Various locations in Portland, Salem, Albany/Corvallis and Eugene

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Parent massage tx group

Parent massage wait-list control group

Arm Description

Children in this group receive the parent-delivered massage intervention right after randomization.

Children in this group receive the parent-delivered massage intervention 5 months after randomization.

Outcomes

Primary Outcome Measures

Change in severity of autism
The Childhood Autism Rating Scales will be used to measure this.

Secondary Outcome Measures

Change in developmental skills
The Vineland II will be used to measure this.

Full Information

First Posted
August 15, 2014
Last Updated
April 27, 2016
Sponsor
Western Oregon University
Collaborators
HRSA/Maternal and Child Health Bureau
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1. Study Identification

Unique Protocol Identification Number
NCT02222662
Brief Title
Parent-delivered Massage for Children With Autism - Ages 6 to 11
Official Title
Phase 1 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism Ages 6 to 11
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western Oregon University
Collaborators
HRSA/Maternal and Child Health Bureau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
Massage, effectiveness, autism, parent stress

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Parent massage tx group
Arm Type
Experimental
Arm Description
Children in this group receive the parent-delivered massage intervention right after randomization.
Arm Title
Parent massage wait-list control group
Arm Type
Experimental
Arm Description
Children in this group receive the parent-delivered massage intervention 5 months after randomization.
Intervention Type
Other
Intervention Name(s)
Parent massage tx group
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Parent massage wait-list control group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in severity of autism
Description
The Childhood Autism Rating Scales will be used to measure this.
Time Frame
5 months and one year
Secondary Outcome Measure Information:
Title
Change in developmental skills
Description
The Vineland II will be used to measure this.
Time Frame
5 months and one year
Other Pre-specified Outcome Measures:
Title
Change in communication skills
Description
The Preschool Language Scale-5 will be used to measure this.
Time Frame
5 months and one year
Title
Change in co-morbid symptoms of autism
Description
The Sense and Self-Regulation Checklist will be used to measure this.
Time Frame
5 months and one year
Title
Change in degree of parenting stress
Description
The Autism Parenting Stress Index will be used to measure this.
Time Frame
5 months and one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louisa Silva, MD MPH
Organizational Affiliation
Western Oregon University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Various locations in Portland, Salem, Albany/Corvallis and Eugene
City
Portland, Salem, Albany, Corvallis, Eugene
State/Province
Oregon
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
19708471
Citation
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.
Results Reference
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PubMed Identifier
24298297
Citation
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.
Results Reference
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PubMed Identifier
22026323
Citation
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.
Results Reference
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PubMed Identifier
21660676
Citation
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.
Results Reference
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PubMed Identifier
25878901
Citation
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.
Results Reference
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Links:
URL
http://qsti.org
Description
Qigong Sensory Treatment Massage for Autism

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

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