Parent-delivered Massage for Children With Autism

Western Oregon University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Autism

Treatments: Other: Parent massage tx group; Other: Parent massage wait-list control group

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01801696

R40MC24945(1)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 103 patients

Sex: All

Ages: 2 to 5 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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103 participants in 2 patient groups

Parent massage tx group

Experimental group

Description:

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

Treatment:

Other: Parent massage tx group

Parent massage wait-list control group

Experimental group

Description:

Children in this group receive the parent-delivered massage intervention 5 months after randomization.

Treatment:

Other: Parent massage wait-list control group