Parent-delivered Massage for Children With Autism

Autism Clinical Trial

Official title:

Phase 2 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01801696
• Other study ID #: R40MC24945(1)
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: February 20, 2013
• Last updated: April 27, 2016
• Start date: September 2012
• Est. completion date: March 2016

Study information

• Verified date: April 2016
• Source: Western Oregon University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2016
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 5 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism
• Autistic Disorder

Intervention

Other:
• Parent massage tx group
The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
• Parent massage wait-list control group
The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.

Locations

Country	Name	City	State
United States	Various locations in Albany and Corvallis	Corvallis	Oregon
United States	Various locations in Eugene, Oregon	Eugene	Oregon
United States	Various locations in Portland, Oregon	Portland	Oregon
United States	Various locations in Salem, Oregon	Salem	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Western Oregon University	HRSA/Maternal and Child Health Bureau

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Stu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Communication skills	The PLS-5 will be used to measure this.	5 months	No
Other	Co-morbid symptoms of autism	The Sense and Self-Regulation Checklist will be used to measure this.	5 months	No
Other	Degree of parenting stress	The Autism Parenting Stress Index will be used to measure this.	5 months	No
Primary	Severity of autism	The Childhood Autism Rating Scales will be used to measure this.	5 months	No
Secondary	Developmental skills	The Vineland II will be used to measure this.	5 months	No

External Links

•   Information regarding the treatment protocol