NCT02222662

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 21, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 29, 2016

Status Verified

December 1, 2015

Enrollment Period

1.7 years

First QC Date

August 15, 2014

Last Update Submit

April 27, 2016

Conditions

Keywords

Massageeffectivenessautismparent stress

Outcome Measures

Primary Outcomes (1)

  • Change in severity of autism

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

    5 months and one year

Secondary Outcomes (1)

  • Change in developmental skills

    5 months and one year

Other Outcomes (3)

  • Change in communication skills

    5 months and one year

  • Change in co-morbid symptoms of autism

    5 months and one year

  • Change in degree of parenting stress

    5 months and one year

Study Arms (2)

Parent massage tx group

EXPERIMENTAL

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

Other: Parent massage tx group

Parent massage wait-list control group

EXPERIMENTAL

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

Other: Parent massage wait-list control group

Interventions

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.

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.

Parent massage wait-list control group

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Portland, Salem, Albany, Corvallis, Eugene, Oregon, United States

Location

Related Publications (5)

  • 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.

    PMID: 19708471BACKGROUND
  • 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.

    PMID: 24298297BACKGROUND
  • 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.

    PMID: 22026323BACKGROUND
  • 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.

    PMID: 21660676BACKGROUND
  • 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.

    PMID: 25878901BACKGROUND

Related Links

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Louisa Silva, MD MPH

    Western Oregon University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Visiting Professor

Study Record Dates

First Submitted

August 15, 2014

First Posted

August 21, 2014

Study Start

June 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 29, 2016

Record last verified: 2015-12

Locations