Skip to main content
OpenTrials
Completed

NCT Number: NCT01801696

Parent-delivered Massage for Children With Autism

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

2 year–5 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Various locations in Albany and Corvallis, Corvallis, Oregon, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Parent massage tx group

Other

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

Other

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.

Primary outcomes

  1. Severity of autism

    Time frame: 5 months

    The Childhood Autism Rating Scales will be used to measure this.

Secondary outcomes

  1. Developmental skills

    Time frame: 5 months

    The Vineland II will be used to measure this.

Other outcomes

  1. Communication skills

    Time frame: 5 months

    The PLS-5 will be used to measure this.

  2. Co-morbid symptoms of autism

    Time frame: 5 months

    The Sense and Self-Regulation Checklist will be used to measure this.

  3. Degree of parenting stress

    Time frame: 5 months

    The Autism Parenting Stress Index will be used to measure this.

Sponsors and collaborators

Lead sponsor

Western Oregon University

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2016
First posted
Mar 1, 2013
Registry last updated
Apr 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.