Parent-delivered Massage for Children With Autism - Ages 6 to 11

Study Overview
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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 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.

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. 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.

Official Title
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Phase 1 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism Ages 6 to 11

Conditions
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Autism

Intervention / Treatment
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* Other: Parent massage tx group
* Other: Parent massage wait-list control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of autism | The Childhood Autism Rating Scales will be used to measure this. | 5 months and one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in developmental skills | The Vineland II will be used to measure this. | 5 months and one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, effectiveness, autism, parent stress