Clinical trial NCT01801696: Parent-delivered Massage for Children With Autism
Official title: Phase 2 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
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: 2013-03-01
Enrollment: 103
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Severity of autism
timeFrame: 5 months
Secondary outcomes:
measure: Developmental skills
timeFrame: 5 months
Other outcomes:
measure: Communication skills
timeFrame: 5 months
measure: Co-morbid symptoms of autism
timeFrame: 5 months
measure: Degree of parenting stress
timeFrame: 5 months
Locations:
city: Corvallis
country: United States
facility: Various locations in Albany and Corvallis
state: Oregon
city: Eugene
country: United States
facility: Various locations in Eugene, Oregon
state: Oregon
city: Portland
country: United States
facility: Various locations in Portland, Oregon
state: Oregon
city: Salem
country: United States
facility: Various locations in Salem, Oregon
state: Oregon
Study officials:
affiliation: Western Oregon University
name: Louisa Silva, M.D., M.P.H.
role: PRINCIPAL_INVESTIGATOR
affiliation: Western Oregon University
name: Kristen Gabrielsen, M.P.H.
role: STUDY_DIRECTOR
References:
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.