Child Development Disorders, PervasiveNCT00445471
A Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment
A study testing Mifne Approach to PDD and Treatment as usual in people with Child Development Disorders, Pervasive, run by Rabin Medical Center at 1 site in Israel.
Trial summary
The current study aims at comparing outcomes achieved using the Mifne approach of treating autistic children with results obtained when routine standard treatment is used. A prospective comparative study will be performed comparing the results of 12 children treated at Mifne with 12 children treated with treatment as… Read more about this study
- Who is it for?
- Ages 2 to 5 years
- Conditions the study is for
- Child Development Disorders, Pervasive
- What is being tested?
- Mifne Approach to PDD and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2007to Dec 2012
- 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 2 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All children between the ages of 2-5 years who meet diagnostic criteria for Autism or Pervasive Developmental Disorder by DSM IV criteria who are referred for treatment at Mifne for the treatment group.
- The control group will consist of children meeting the same criteria who are referred to Schneider Children's Medical Center of Israel (SCMCI). Matching will be for age, sex, ethnicity, socioeconomic status, IQ, language development and diagnosis.
Who cannot join
- All referred children who do not meet criteria for Autism or PDD or do not understand Hebrew.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Schneider Children's Medical Center of Israel, Departemnt of Psychological Medicine
Petah Tikva
About this study
The current study aims at comparing outcomes achieved using the Mifne approach of treating autistic children with results obtained when routine standard treatment is used. A prospective comparative study will be performed comparing the results of 12 children treated at Mifne with 12 children treated with treatment as usual. A child and adolescent psychiatrist using the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-Generic (ADOS-G) will make the diagnostic assessment and a developmental psychologist will make the developmental and psychological assessments using the Vineland Adaptive Behavior Scales-Revised and the Bayley Scales of Infant Development (BSID II) before the child enters the study. Each child will be reassessed following completion of the Mifne intervention, at three and at six months after commencement of treatment. The control child will also be reassessed at three and at six months after commencement of a therapeutic intervention.
- Conditions
- Child Development Disorders, Pervasive
- Being tested
- Mifne Approach to PDD, Treatment as usual
- Keywords
- Autism Spectrum Disorder, Autistic Disorder, Pervasive Developmental Disorder
- Medical subject headings
- Child Development Disorders, Pervasive, Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mifne Approach to PDDBehavioural
Treatment as usualBehavioural
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Mifne Approach to PDD Receives: Behavioral: Mifne Approach to PDD |
| B | Other | Treatment as usual Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADOS scores at 3 and 6 months after commencement of treatment
Measured: 2.5 years
Secondary outcomes (1)
CGI-I score after 3 and 6 months
Measured: 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startApr 2007
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Mifne began treating younger patients who could not be diagnosed with the ADOS used in the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child Development Disorders, PervasiveStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alan apter, Rabin Medical Center
- Investigators
- Alan Apter, MD, Principal investigator, Director Department of Psychological Medicine Schneider Children's Medical Center of Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00445471
- Sponsor's protocol ID
- 4222
- Status last verified
- Dec 2014
- First submitted
- 8 Mar 2007
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Comparing the Mifne Approach of Treating Childhood Autism With Routine Standard Treatment
- ClinicalTrials.gov ID
- NCT00445471
- Acronym / sponsor ID
- 4222
- Conditions
- Child Development Disorders, Pervasive
- Keywords
- Autism Spectrum Disorder, Autistic Disorder, Pervasive Developmental Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Mifne began treating younger patients who could not be diagnosed with the ADOS used in the study
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 9 Mar 2007 (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 current study aims at comparing outcomes achieved using the Mifne approach of treating autistic children with results obtained when routine standard treatment is used. A prospective comparative study will be performed comparing the results of 12 children treated at Mifne with 12 children treated with treatment as usual. A child and adolescent psychiatrist using the Autism Diagnostic Interview-Revised (ADI-R) and the Autism Diagnostic Observation Schedule-Generic (ADOS-G) will make the diagnostic assessment and a developmental psychologist will make the developmental and psychological assessments using the Vineland Adaptive Behavior Scales-Revised and the Bayley Scales of Infant Development (BSID II) before the child enters the study. Each child will be reassessed following completion of the Mifne intervention, at three and at six months after commencement of treatment. The control child will also be reassessed at three and at six months after commencement of a therapeutic intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Behavioral: Mifne Approach to PDDMifne Approach to PDD |
| B | Other | Behavioral: Treatment as usualTreatment as usual |
Who may qualify
- Ages
- 2 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All children between the ages of 2-5 years who meet diagnostic criteria for Autism or Pervasive Developmental Disorder by DSM IV criteria who are referred for treatment at Mifne for the treatment group.
- The control group will consist of children meeting the same criteria who are referred to Schneider Children's Medical Center of Israel (SCMCI). Matching will be for age, sex, ethnicity, socioeconomic status, IQ, language development and diagnosis.
Key exclusion criteria (1 listed)
- All referred children who do not meet criteria for Autism or PDD or do not understand Hebrew.
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 |
|---|---|---|
| Mifne Approach to PDD | Behavioural | A |
| Treatment as usual | Behavioural | B |
Primary outcome
ADOS scores at 3 and 6 months after commencement of treatment
Time frame: 2.5 years
1 secondary outcome
CGI-I score after 3 and 6 months
Time frame: 2.5 years
Results and safety
The study was stopped early (reason given: Mifne began treating younger patients who could not be diagnosed with the ADOS used in the study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2014.
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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.
Alan Apter, MD principal investigator
Director Department of Psychological Medicine Schneider Children's Medical Center of Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mifne Approach to PDD and Treatment as usual in people with Child Development Disorders, Pervasive, run by Rabin Medical Center at 1 site in Israel.
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 2 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: stopped early, as of the sponsor's last update on 25 Dec 2014. 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 Israel. 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?
The study was stopped early (reason given: Mifne began treating younger patients who could not be diagnosed with the ADOS used in the study). Results are not available in the source record.
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?
ADOS scores at 3 and 6 months after commencement of treatment (time frame: 2.5 years). 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 25 Dec 2014.