Clinical trial NCT02222662: Parent-delivered Massage for Children With Autism - Ages 6 to 11
Official title: Phase 1 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism Ages 6 to 11
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: Massage
effectiveness
autism
parent stress
Lead sponsor: Western Oregon University
Sponsor class: OTHER
Collaborators: name: HRSA/Maternal and Child Health Bureau
First posted: 2014-08-21
Enrollment: 35
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change in severity of autism
timeFrame: 5 months and one year
Secondary outcomes:
measure: Change in developmental skills
timeFrame: 5 months and one year
Other outcomes:
measure: Change in communication skills
timeFrame: 5 months and one year
measure: Change in co-morbid symptoms of autism
timeFrame: 5 months and one year
measure: Change in degree of parenting stress
timeFrame: 5 months and one year
Locations:
city: Portland, Salem, Albany, Corvallis, Eugene
country: United States
facility: Various locations in Portland, Salem, Albany/Corvallis and Eugene
state: Oregon
Study officials:
affiliation: Western Oregon University
name: Louisa Silva, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Silva LM, Schalock M, Ayres R, Bunse C, Budden S. Qigong massage treatment for sensory and self-regulation problems in young children with autism: a randomized controlled trial. Am J Occup Ther. 2009 Jul-Aug;63(4):423-32. doi: 10.5014/ajot.63.4.423.
citation: Silva L, Schalock M. Treatment of tactile impairment in young children with autism: results with qigong massage. Int J Ther Massage Bodywork. 2013 Dec 3;6(4):12-20. doi: 10.3822/ijtmb.v6i4.227. eCollection 2013.
citation: Silva LM, Schalock M, Gabrielsen K. Early intervention for autism with a parent-delivered Qigong massage program: a randomized controlled trial. Am J Occup Ther. 2011 Sep-Oct;65(5):550-9. doi: 10.5014/ajot.2011.000661.
citation: Silva LM, Schalock M, Ayres R. A model and treatment for autism at the convergence of Chinese medicine and Western science: first 130 cases. Chin J Integr Med. 2011 Jun;17(6):421-9. doi: 10.1007/s11655-011-0635-0. Epub 2011 Jun 10.
citation: 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.