Parent-delivered Massage for Children With Autism

April 27, 2016 updated by: Louisa Silva, Western Oregon University

Phase 2 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Various locations in Albany and Corvallis
      • Eugene, Oregon, United States, 97455
        • Various locations in Eugene, Oregon
      • Portland, Oregon, United States, 97232
        • Various locations in Portland, Oregon
      • Salem, Oregon, United States, 97308
        • Various locations in Salem, Oregon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Parent massage tx group
Children in this group receive the parent-delivered massage intervention right after randomization.
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.
Experimental: Parent massage wait-list control group
Children in this group receive the parent-delivered massage intervention 5 months after randomization.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of autism
Time Frame: 5 months
The Childhood Autism Rating Scales will be used to measure this.
5 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Developmental skills
Time Frame: 5 months
The Vineland II will be used to measure this.
5 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Communication skills
Time Frame: 5 months
The PLS-5 will be used to measure this.
5 months
Co-morbid symptoms of autism
Time Frame: 5 months
The Sense and Self-Regulation Checklist will be used to measure this.
5 months
Degree of parenting stress
Time Frame: 5 months
The Autism Parenting Stress Index will be used to measure this.
5 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Western Oregon University

Collaborators

HRSA/Maternal and Child Health Bureau

Investigators

  • Principal Investigator: Louisa Silva, M.D., M.P.H., Western Oregon University
  • Study Director: Kristen Gabrielsen, M.P.H., Western Oregon University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 20, 2013

First Submitted That Met QC Criteria

February 26, 2013

First Posted (Estimate)

March 1, 2013

Study Record Updates

Last Update Posted (Estimate)

April 29, 2016

Last Update Submitted That Met QC Criteria

April 27, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R40MC24945(1)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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