NCT01801696

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2012

Typical duration for phase_2

Geographic Reach
1 country

4 active sites

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

September 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 20, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 1, 2013

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

2.2 years

First QC Date

February 20, 2013

Last Update Submit

April 27, 2016

Conditions

Autism

Keywords

Massageeffectivenessautismparent stress

Outcome Measures

Primary Outcomes (1)

  • Severity of autism

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

    5 months

Secondary Outcomes (1)

  • Developmental skills

    5 months

Other Outcomes (3)

  • Communication skills

    5 months

  • Co-morbid symptoms of autism

    5 months

  • Degree of parenting stress

    5 months

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

Parent massage tx groupOTHER

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
Parent massage wait-list control groupOTHER

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

Age2 Years - 5 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

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 five hours per week of intensive behavioral treatment for autism (e.g. ABA therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Various locations in Albany and Corvallis

Corvallis, Oregon, 97330, United States

Location

Various locations in Eugene, Oregon

Eugene, Oregon, 97455, United States

Location

Various locations in Portland, Oregon

Portland, Oregon, 97232, United States

Location

Various locations in Salem, Oregon

Salem, Oregon, 97308, United States

Location

Related Publications (1)

  • 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: 25878901RESULT

Related Links

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Louisa Silva, M.D., M.P.H.

    Western Oregon University

    PRINCIPAL INVESTIGATOR

  • Kristen Gabrielsen, M.P.H.

    Western Oregon University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
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

February 20, 2013

First Posted

March 1, 2013

Study Start

September 1, 2012

Primary Completion

November 1, 2014

Study Completion

March 1, 2016

Last Updated

April 29, 2016

Record last verified: 2016-04

Locations

US(4)