Parent-delivered Massage for Children With Autism

Phase 2

Completed

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

• Registration Number: NCT01801696
• 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 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

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-02-20
• Study First Submitted QC: 2013-02-26
• Study First Posted: 2013-03-01
• Primary Completion: 2014-11
• Study Completion: 2016-03
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-27
• Last Update Posted: 2016-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Severity of autism	5 months	The Childhood Autism Rating Scales will be used to measure this.

Secondary Outcome Measures

Name	Time	Method
Developmental skills	5 months	The Vineland II will be used to measure this.

Trial Locations

Locations (4)

Various locations in Albany and Corvallis; 🇺🇸 Corvallis, Oregon, United States

Various locations in Salem, Oregon; 🇺🇸 Salem, Oregon, United States

Various locations in Eugene, Oregon; 🇺🇸 Eugene, Oregon, United States

Various locations in Portland, Oregon; 🇺🇸 Portland, Oregon, United States