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Parent-delivered Massage for Children With Autism

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01801696
Enrollment
103
Registered
2013-03-01
Start date
2012-09-30
Completion date
2016-03-31
Last updated
2016-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism

Keywords

Massage, effectiveness, autism, parent stress

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.

Interventions

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.

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.

Sponsors

HRSA/Maternal and Child Health Bureau
CollaboratorFED
Western Oregon University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 5 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Severity of autism5 monthsThe Childhood Autism Rating Scales will be used to measure this.

Secondary

MeasureTime frameDescription
Developmental skills5 monthsThe Vineland II will be used to measure this.

Other

MeasureTime frameDescription
Communication skills5 monthsThe PLS-5 will be used to measure this.
Co-morbid symptoms of autism5 monthsThe Sense and Self-Regulation Checklist will be used to measure this.
Degree of parenting stress5 monthsThe Autism Parenting Stress Index will be used to measure this.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026