Parent-delivered Massage for Children With Autism

NCT ID: NCT01801696

Last Updated: 2016-04-29

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

103 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Autism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Parent massage tx group

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

Group Type EXPERIMENTAL

Parent massage tx group

Intervention Type OTHER

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.

Group Type EXPERIMENTAL

Parent massage wait-list control group

Intervention Type OTHER

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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

2 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HRSA/Maternal and Child Health Bureau

FED

Sponsor Role collaborator

Western Oregon University

OTHER

Sponsor Role lead

Responsible Party

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Louisa Silva

Principal Investigator, Visiting Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Various locations in Eugene, Oregon

Eugene, Oregon, United States

Site Status

Various locations in Portland, Oregon

Portland, Oregon, United States

Site Status

Various locations in Salem, Oregon

Salem, Oregon, United States

Site Status

Countries

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United States

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.

Reference Type RESULT
PMID: 25878901 (View on PubMed)

Related Links

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http://qsti.org

Information regarding the treatment protocol

Other Identifiers

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R40MC24945(1)

Identifier Type: -

Identifier Source: org_study_id

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