AutismPhase 2/3NCT01801696
Parent-delivered Massage for Children With Autism
A Phase 2/3 study testing Parent massage tx group in people with Autism, run by Western Oregon University at 4 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Autism
- What is being tested?
- Parent massage tx group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2012to Mar 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Various locations in Albany and Corvallis
Corvallis, Oregon, 97330
Various locations in Eugene, Oregon
Eugene, Oregon, 97455
Various locations in Portland, Oregon
Portland, Oregon, 97232
Various locations in Salem, Oregon
Salem, Oregon, 97308
About this study
Official title: Phase 2 Study of the Parent-delivered Massage Treatment Protocol 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.
Read the 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.
- Conditions
- Autism
- Being tested
- Parent massage tx group, Parent massage wait-list control group
- Keywords
- Massage, effectiveness, autism, parent stress
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent massage tx groupOther
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 groupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Parent massage tx group | Experimental | Children in this group receive the parent-delivered massage intervention right after randomization. Receives: Other: Parent massage tx group |
| Parent massage wait-list control group | Experimental | Children in this group receive the parent-delivered massage intervention 5 months after randomization. Receives: Other: Parent massage wait-list control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of autism
The Childhood Autism Rating Scales will be used to measure this.
Measured: 5 months
Secondary outcomes (1)
Developmental skills
The Vineland II will be used to measure this.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2013 (estimated)
- Study startSep 2012
- Primary completionNov 2014
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Oregon University
- Sponsor type
- University, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Responsible party
- Principal investigator, Louisa Silva, Western Oregon University
- Investigators
- Louisa Silva, M.D., M.P.H., Principal investigator, Western Oregon UniversityKristen Gabrielsen, M.P.H., Study director, Western Oregon University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01801696
- Sponsor's protocol ID
- R40MC24945(1)
- Status last verified
- Apr 2016
- First submitted
- 20 Feb 2013
- Last updated
- 29 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 25878901
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of the Parent-delivered Massage Treatment Protocol for Children With Autism
- ClinicalTrials.gov ID
- NCT01801696
- Acronym / sponsor ID
- R40MC24945(1)
- Conditions
- Autism
- Keywords
- Massage, effectiveness, autism, parent stress
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Western Oregon UniversityUniversity, hospital or other
- Collaborators
- HRSA/Maternal and Child Health Bureau
- Study start
- Sep 2012
- Primary completion
- Nov 2014 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 1 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parent massage tx group | Experimental | Other: Parent massage tx groupChildren in this group receive the parent-delivered massage intervention right after randomization. |
| Parent massage wait-list control group | Experimental | Other: Parent massage wait-list control groupChildren in this group receive the parent-delivered massage intervention 5 months after randomization. |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent massage tx groupThe 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. | Other | Parent massage tx group |
| Parent massage wait-list control groupThe 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. | Other | Parent massage wait-list control group |
Primary outcome
Severity of autism
Time frame: 5 months
The Childhood Autism Rating Scales will be used to measure this.
1 secondary outcome
Developmental skills
Time frame: 5 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2016.
- Results publication: PubMed 25878901Silva 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.
- Information regarding the treatment protocolLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Louisa Silva, M.D., M.P.H. principal investigator
Western Oregon University
Kristen Gabrielsen, M.P.H. study director
Western Oregon University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Parent massage tx group in people with Autism, run by Western Oregon University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of autism (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01801696, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2016.