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

Not Applicable

Completed

• Conditions: Autism
• Interventions: Other: Parent massage tx group; Other: Parent massage wait-list control group

• Registration Number: NCT02222662
• Lead Sponsor: Western Oregon University

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.

Detailed Description

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2014-08-15
• Study First Submitted QC: 2014-08-19
• Study First Posted: 2014-08-21
• Status Verified: 2015-12
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parent massage tx group	Parent massage tx group	Children in this group receive the parent-delivered massage intervention right after randomization.
Parent massage wait-list control group	Parent massage wait-list control group	Children in this group receive the parent-delivered massage intervention 5 months after randomization.

Primary Outcome Measures

Name	Time	Method
Change in severity of autism	5 months and one year	The Childhood Autism Rating Scales will be used to measure this.

Secondary Outcome Measures

Name	Time	Method
Change in developmental skills	5 months and one year	The Vineland II will be used to measure this.

Trial Locations

Locations (1)

Various locations in Portland, Salem, Albany/Corvallis and Eugene; 🇺🇸 Portland, Salem, Albany, Corvallis, Eugene, Oregon, United States