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Parent-delivered Massage for Children With Autism

Primary Purpose

Autism

Status
Completed
Phase
Phase 2
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

2 Years - 5 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Have a medical and/or educational diagnosis of autism
  • Be under age 6
  • 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 five hours per week of intensive behavioral treatment for autism (e.g. ABA therapy)

Sites / Locations

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

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

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

Secondary Outcome Measures

Developmental skills
The Vineland II will be used to measure this.

Full Information

First Posted
February 20, 2013
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
NCT01801696
Brief Title
Parent-delivered Massage for Children With Autism
Official Title
Phase 2 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
March 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 young children 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. Follow-up testing will be conducted at the end of the second year. 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
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
103 (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
Severity of autism
Description
The Childhood Autism Rating Scales will be used to measure this.
Time Frame
5 months
Secondary Outcome Measure Information:
Title
Developmental skills
Description
The Vineland II will be used to measure this.
Time Frame
5 months
Other Pre-specified Outcome Measures:
Title
Communication skills
Description
The PLS-5 will be used to measure this.
Time Frame
5 months
Title
Co-morbid symptoms of autism
Description
The Sense and Self-Regulation Checklist will be used to measure this.
Time Frame
5 months
Title
Degree of parenting stress
Description
The Autism Parenting Stress Index will be used to measure this.
Time Frame
5 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have a medical and/or educational diagnosis of autism Be under age 6 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 five hours per week of intensive behavioral treatment for autism (e.g. ABA therapy)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Louisa Silva, M.D., M.P.H.
Organizational Affiliation
Western Oregon University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kristen Gabrielsen, M.P.H.
Organizational Affiliation
Western Oregon University
Official's Role
Study Director
Facility Information:
Facility Name
Various locations in Albany and Corvallis
City
Corvallis
State/Province
Oregon
ZIP/Postal Code
97330
Country
United States
Facility Name
Various locations in Eugene, Oregon
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97455
Country
United States
Facility Name
Various locations in Portland, Oregon
City
Portland
State/Province
Oregon
ZIP/Postal Code
97232
Country
United States
Facility Name
Various locations in Salem, Oregon
City
Salem
State/Province
Oregon
ZIP/Postal Code
97308
Country
United States

12. IPD Sharing Statement

Citations:
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
result
Links:
URL
http://qsti.org
Description
Information regarding the treatment protocol

Learn more about this trial

Parent-delivered Massage for Children With Autism

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