Developmental DisabilitiesDIDDNCT01166152
Development of a New Diagnosis and Intervention Method for Developmental Disorders
A study testing social skills training in people with Developmental Disabilities, run by Tokyo University of Agriculture and Technology at 1 site in Japan.
Trial summary
The purpose of this study is to develop a new diagnostic method for developmental disorders based on behavior recording during the interview of the subjects by medical staff as well anonymous persons. Read more about this study
- Who is it for?
- Ages Up to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Developmental Disabilities
- What is being tested?
- social skills training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteJapan
- Study dates
- Aug 2010to Mar 2013
- Phase
- Interventional
- 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 Up to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Developmental disorders
Who cannot join
- Mental retardation
Trial locations and contacts
1 site in 1 country.
Japan1 site, 1 recruiting
- Recruiting
Ashiya University Graduate School of Clinical Education
Ashiya, Hyōgo, 659-8511
Kunio Yui, MD, 81-797-23-0661, yui16@bell.ocn.ne.jp
Shun Nakamura, PhD, 81-423-88-7770, nakashn@cc.tuat.ac.jp
About this study
The purpose of this study is to develop a new diagnostic method for developmental disorders based on behavior recording during the interview of the subjects by medical staff as well anonymous persons. The behavior recording by video camera will be accompanied by non-invasive physiological recordings, including electroencephalogram (EEG), electrocardiogram (ECG), electromyogram (EMG), and body temperature using infrared (IR) thermograph. Thus, the physiologically relevant and the disorder correlated behavior parameters could be extracted and used as new diagnostic markers. If necessary, the medical staff may take blood sample from the subject before and after the interview. For the longitudinal study, the similar interview and the recording of the same subject will be planned to evaluate the effect of the medical and educational intervention. The investigators also examine the synergistic effect of the intervention and the administration of the supplement (e.g., vitamin D, arachidonic acid, coenzyme Q10 (CoQ-10)). The clinician may use Risperidone.
Read the detailed description
Case 1:The investigators started the intervention and supplementation of arachidonic acid for 3 patients diagnosed as autistic spectrum disorders (ASD) from September 4, 2010 at Sawa hospital (Osaka, Japan). Another ASD patients (n=5) at Sawa hospital were treated by administration of Risperidone as medicinal drink from January 14, 2011. The supplementation as well as Risperidone administration followed double-blind placebo controlled cross-over protocol to access the effect of the treatment. These trials will continue until November 2011. Final outcome will be evaluated by clinical diagnosis and behavior parameters measurement as described under Brief Summary.
Case 2: The investigators started the intervention and supplementation of reduced form of CoQ10 for learning disability children (n=20) at small private cramming school (JIZAI-ken, Tokyo) from February 5, 2011. This trial will continue until October 2011. The effect of the intervention and supplementation will be evaluated by behavior parameter measurement as described above.
- Conditions
- Developmental Disabilities
- Being tested
- social skills training
- Keywords
- autistic spectrum disorders, developmental disorders
- Medical subject headings
- Developmental Disabilities, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social skills trainingBehavioural
meeting once a week or biweekly to play together using toys, games, and physical exercises.
What is being measured
The primary outcome is the main question the study is designed to answer.
thermogram of head
The themogram of head will be measured using IR camera (TVS-500EX, NEC Avio) during clinical interview to see the change of autonomic nervous system activity.
Measured: at least 8 weeks after intervention
Secondary outcomes (1)
view direction
The subject view direction will be monitored using the video camera (Sony) during clinical interview.
Measured: at least 8 weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2011 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DisabilitiesStudies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tokyo University of Agriculture and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Ashiya University, Saitama Medical University
- Investigators
- Kunio Yui, MD, PhD, Principal investigator, Ashiya UniversityHideo Yamauchi, MD, PhD, Principal investigator, Saitama Medical UniversityMamiko Koshiba, PhD, Principal investigator, Tokyo University of Agriculture and TechinologyShun Nakamura, PhD, Principal investigator, Tokyo University of Agriculture and Techinology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01166152
- Sponsor's protocol ID
- TokyoUAT_21_11
- Acronym
- DIDD
- Status last verified
- Jul 2010
- First submitted
- 19 Jul 2010
- Last updated
- 21 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a New Diagnosis and Intervention Method for Developmental Disorders
- ClinicalTrials.gov ID
- NCT01166152
- Acronym / sponsor ID
- DIDD / TokyoUAT_21_11
- Conditions
- Developmental Disabilities
- Keywords
- autistic spectrum disorders, developmental disorders
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Tokyo University of Agriculture and TechnologyUniversity, hospital or other
- Collaborators
- Ashiya University, Saitama Medical University
- Study start
- Aug 2010
- Primary completion
- Nov 2011 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 20 Jul 2010 (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.
The purpose of this study is to develop a new diagnostic method for developmental disorders based on behavior recording during the interview of the subjects by medical staff as well anonymous persons. The behavior recording by video camera will be accompanied by non-invasive physiological recordings, including electroencephalogram (EEG), electrocardiogram (ECG), electromyogram (EMG), and body temperature using infrared (IR) thermograph. Thus, the physiologically relevant and the disorder correlated behavior parameters could be extracted and used as new diagnostic markers. If necessary, the medical staff may take blood sample from the subject before and after the interview. For the longitudinal study, the similar interview and the recording of the same subject will be planned to evaluate the effect of the medical and educational intervention. The investigators also examine the synergistic effect of the intervention and the administration of the supplement (e.g., vitamin D, arachidonic acid, coenzyme Q10 (CoQ-10)). The clinician may use Risperidone.
Detailed description
Case 1:The investigators started the intervention and supplementation of arachidonic acid for 3 patients diagnosed as autistic spectrum disorders (ASD) from September 4, 2010 at Sawa hospital (Osaka, Japan). Another ASD patients (n=5) at Sawa hospital were treated by administration of Risperidone as medicinal drink from January 14, 2011. The supplementation as well as Risperidone administration followed double-blind placebo controlled cross-over protocol to access the effect of the treatment. These trials will continue until November 2011. Final outcome will be evaluated by clinical diagnosis and behavior parameters measurement as described under Brief Summary.
Case 2: The investigators started the intervention and supplementation of reduced form of CoQ10 for learning disability children (n=20) at small private cramming school (JIZAI-ken, Tokyo) from February 5, 2011. This trial will continue until October 2011. The effect of the intervention and supplementation will be evaluated by behavior parameter measurement as described above.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- Up to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Developmental disorders
Key exclusion criteria (1 listed)
- Mental retardation
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 |
|---|---|---|
| social skills trainingmeeting once a week or biweekly to play together using toys, games, and physical exercises. | Behavioural | – |
Primary outcome
thermogram of head
Time frame: at least 8 weeks after intervention
The themogram of head will be measured using IR camera (TVS-500EX, NEC Avio) during clinical interview to see the change of autonomic nervous system activity.
1 secondary outcome
view direction
Time frame: at least 8 weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2011.
Related trials for Developmental Disabilities
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Recruiting
Word Learning From Parentese in Autistic Children
Autism, Autism Spectrum Disorder
Recruiting
COMPASS Across Settings (CAST) for Improving Transition Outcomes for Students With ASD
Autism, Autism Spectrum Disorder
Recruiting
Impact of an E-Learning Coaching for Parents of Young Children With Autism
Autism Spectrum Disorder
Not yet recruiting
Evaluation of a Novel Quantum-Inspired Intervention (QII) for Children With Autism Spectrum Disorder: A Global Confirmatory Study
Autism Spectrum Disorder, Autism Spectrum Disorder (ASD
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.
Ashiya University Graduate School of Clinical Education
Ashiya, Japan
Kunio Yui, MD, PhD principal investigator
Ashiya University
Hideo Yamauchi, MD, PhD principal investigator
Saitama Medical University
Mamiko Koshiba, PhD principal investigator
Tokyo University of Agriculture and Techinology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social skills training in people with Developmental Disabilities, run by Tokyo University of Agriculture and Technology at 1 site in Japan.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
thermogram of head (time frame: at least 8 weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jul 2011.