Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
103 participants
INTERVENTIONAL
2012-09-30
2016-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Parent massage tx group
Children in this group receive the parent-delivered massage intervention right after randomization.
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
Children in this group receive the parent-delivered massage intervention 5 months after randomization.
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
2 Years
5 Years
ALL
No
Sponsors
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HRSA/Maternal and Child Health Bureau
FED
Western Oregon University
OTHER
Responsible Party
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Louisa Silva
Principal Investigator, Visiting Professor
Principal Investigators
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Louisa Silva, M.D., M.P.H.
Role: PRINCIPAL_INVESTIGATOR
Western Oregon University
Kristen Gabrielsen, M.P.H.
Role: STUDY_DIRECTOR
Western Oregon University
Locations
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Various locations in Albany and Corvallis
Corvallis, Oregon, United States
Various locations in Eugene, Oregon
Eugene, Oregon, United States
Various locations in Portland, Oregon
Portland, Oregon, United States
Various locations in Salem, Oregon
Salem, Oregon, United States
Countries
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References
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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.
Related Links
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Information regarding the treatment protocol
Other Identifiers
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R40MC24945(1)
Identifier Type: -
Identifier Source: org_study_id
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