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Trial record 14 of 37 for:    Developmental Disabilities | ( Map: Oregon, United States )

Parent-delivered Massage for Children With Autism

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ClinicalTrials.gov Identifier: NCT01801696
Recruitment Status : Completed
First Posted : March 1, 2013
Last Update Posted : April 29, 2016
Sponsor:
Collaborator:
HRSA/Maternal and Child Health Bureau
Information provided by (Responsible Party):
Louisa Silva, Western Oregon University

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.

Condition or disease Intervention/treatment Phase
Autism Other: Parent massage tx group Other: Parent massage wait-list control group Phase 2 Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism
Study Start Date : September 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Parent massage tx group
Children in this group receive the parent-delivered massage intervention right after randomization.
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.

Experimental: Parent massage wait-list control group
Children in this group receive the parent-delivered massage intervention 5 months after randomization.
Other: 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.




Primary Outcome Measures :
  1. Severity of autism [ Time Frame: 5 months ]
    The Childhood Autism Rating Scales will be used to measure this.


Secondary Outcome Measures :
  1. Developmental skills [ Time Frame: 5 months ]
    The Vineland II will be used to measure this.


Other Outcome Measures:
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01801696


Locations
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United States, Oregon
Various locations in Albany and Corvallis
Corvallis, Oregon, United States, 97330
Various locations in Eugene, Oregon
Eugene, Oregon, United States, 97455
Various locations in Portland, Oregon
Portland, Oregon, United States, 97232
Various locations in Salem, Oregon
Salem, Oregon, United States, 97308
Sponsors and Collaborators
Western Oregon University
HRSA/Maternal and Child Health Bureau
Investigators
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Principal Investigator: Louisa Silva, M.D., M.P.H. Western Oregon University
Study Director: Kristen Gabrielsen, M.P.H. Western Oregon University

Additional Information:
Publications of Results:
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Responsible Party: Louisa Silva, Principal Investigator, Visiting Professor, Western Oregon University
ClinicalTrials.gov Identifier: NCT01801696     History of Changes
Other Study ID Numbers: R40MC24945(1)
First Posted: March 1, 2013    Key Record Dates
Last Update Posted: April 29, 2016
Last Verified: April 2016

Keywords provided by Louisa Silva, Western Oregon University:
Massage
effectiveness
autism
parent stress

Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders