Autistic DisorderNCT00004449
Randomized Study of Intensive One-on-one Behavioral Treatment for Preschool Aged Children With Autism
A study testing intensive one-on-one behavioral treatment and Individualized in home parent training in people with Autistic Disorder, run by University of California, Los Angeles.
Trial summary
OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism. II. Identify intake measures that predict differences in outcome between subjects in the experimental group. Read more about this study
- Who is it for?
- Ages 2 to 3 years
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- intensive one-on-one behavioral treatment and Individualized in home parent training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- May 1998to Apr 2006
- 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 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- --Disease Characteristics--
- Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria
- Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development
- --Patient Characteristics--
- Other:
- Must reside within 60 km (37.5 miles) of a treatment site
Who cannot join
- Severe medically induced limitations defined as:
- Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy)
- Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease)
- Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome)
- Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)
About this study
Official title: Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism.
II. Identify intake measures that predict differences in outcome between subjects in the experimental group.
Read the detailed description
PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months.
A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.
- Conditions
- Autistic Disorder
- Being tested
- intensive one-on-one behavioral treatment, Individualized in home parent training
- Keywords
- autism, neurologic and psychiatric disorders, rare disease
- Medical subject headings
- Autistic Disorder, Neurologic Manifestations, Mental Disorders, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intensive one-on-one behavioral treatmentBehavioural
Up to 40 hours per week of one-to-one intervention based on applied behavior analysis
Individualized in home parent trainingBehavioural
Offered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
IQ
Measured: yearly for up to 4 years
Bayley Scales of Infant Development
Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III
Measured: yearly for up to 4 years
Secondary outcomes (3)
Merrill-Palmer Scale of Mental Tests
Nonverbal cognitive skills
Measured: yearly for up to 4 years
Reynell Developmental Language Scales
Language comprehension and expressive language
Measured: yearly for up to 4 years
Vineland Adaptive Behavior Scales - Survey Edition
Parent interview on child's adaptive functioning
Measured: yearly for up to 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 1999 (estimated)
- Study startMay 1998
- Primary completionSep 2004
- Study completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Tristram Smith, Ph.D., University of Rochester
- Investigators
- Tristram Smith, Ph.D., Study director, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00004449
- Sponsor's protocol ID
- R01MH048863
- Other IDs
- R01MH048863, UCLA-HSPC-G930506611
- Status last verified
- May 2015
- First submitted
- 18 Oct 1999
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen H, Amerine-Dickens M, Smith T. Early intensive behavioral treatment: replication of the UCLA model in a community setting. J Dev Behav Pediatr. 2006 Apr;27(2 Suppl):S145-55. doi: 10.1097/00004703-200604002-00013.
PubMed 16685181Sallows GO, Graupner TD. Intensive behavioral treatment for children with autism: four-year outcome and predictors. Am J Ment Retard. 2005 Nov;110(6):417-38. doi: 10.1352/0895-8017(2005)110[417:IBTFCW]2.0.CO;2.
PubMed 16212446Hayward D, Eikeseth S, Gale C, Morgan S. Assessing progress during treatment for young children with autism receiving intensive behavioural interventions. Autism. 2009 Nov;13(6):613-33. doi: 10.1177/1362361309340029.
PubMed 19933766
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Study of Intensive One-on-one Behavioral Treatment Versus Individualized Parent Training in Preschool Aged Children With Autism
- ClinicalTrials.gov ID
- NCT00004449
- Acronym / sponsor ID
- R01MH048863
- Conditions
- Autistic Disorder
- Keywords
- autism, neurologic and psychiatric disorders, rare disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 1998
- Primary completion
- Sep 2004 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 19 Oct 1999 (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.
OBJECTIVES: I. Determine the effectiveness of intensive one-on-one behavioral treatment in the home or neighborhood compared with at home, individualized, parent training in preschool aged children with autism.
II. Identify intake measures that predict differences in outcome between subjects in the experimental group.
Detailed description
PROTOCOL OUTLINE: This is a randomized study. Children are randomized to receive either 35 hours of intensive one-on-one behavioral treatment in the home and neighborhood for 2 years or individualized, in home parent training for 6 months.
A common group of tests to evaluate autism are administered at intake, 12 and 24 months into treatment, and when patients reach age 6.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- --Disease Characteristics--
- Diagnosis of autism based on the Autism Diagnostic Interview using the ICD-10 research criteria
- Ratio IQ score greater than 35 determined from the Bayley Scales of Infant Development
- --Patient Characteristics--
- Must reside within 60 km (37.5 miles) of a treatment site
Key exclusion criteria (5 listed)
- Any condition requiring prosthetic devices (e.g., blindness, deafness, or cerebral palsy)
- Any illness that has prevented or would prevent a subject from participating in 30 hours a week of treatment for six consecutive weeks or more (e.g., metastasized cancer or end stage renal disease)
- Any known genetic disorder (e.g., Fragile X, PKU, or Down Syndrome)
- Any other disorder that rules out autism according to ICD-10 criteria (e.g., Rett's Syndrome)
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 |
|---|---|---|
| intensive one-on-one behavioral treatmentUp to 40 hours per week of one-to-one intervention based on applied behavior analysis | Behavioural | – |
| Individualized in home parent trainingOffered to subjects at some sites, involved 3+ months of individualized training for parents on applied behavior analysis intervention | Behavioural | – |
Primary outcome
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed.
Time frame: yearly for up to 4 years
IQ
Bayley Scales of Infant Development
Time frame: yearly for up to 4 years
Alternate cognitive test administered to participants who did not achieve basal on WPPSI-III
3 secondary outcomes
Merrill-Palmer Scale of Mental Tests
Time frame: yearly for up to 4 years
Reynell Developmental Language Scales
Time frame: yearly for up to 4 years
Vineland Adaptive Behavior Scales - Survey Edition
Time frame: yearly for up to 4 years
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 27 May 2015.
- Results publication: PubMed 16685181Cohen H, Amerine-Dickens M, Smith T. Early intensive behavioral treatment: replication of the UCLA model in a community setting. J Dev Behav Pediatr. 2006 Apr;27(2 Suppl):S145-55. doi: 10.1097/00004703-200604002-00013.
- Results publication: PubMed 16212446Sallows GO, Graupner TD. Intensive behavioral treatment for children with autism: four-year outcome and predictors. Am J Ment Retard. 2005 Nov;110(6):417-38. doi: 10.1352/0895-8017(2005)110[417:IBTFCW]2.0.CO;2.
- Results publication: PubMed 19933766Hayward D, Eikeseth S, Gale C, Morgan S. Assessing progress during treatment for young children with autism receiving intensive behavioural interventions. Autism. 2009 Nov;13(6):613-33. doi: 10.1177/1362361309340029.
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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.
Tristram Smith, Ph.D. study director
University of Rochester
Questions about this trial
What is this clinical trial studying?
A study testing intensive one-on-one behavioral treatment and Individualized in home parent training in people with Autistic Disorder, run by University of California, Los Angeles.
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 6 inclusion and 5 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Wechsler Preschool and Primary Scales of Intelligence, 3rd ed. (time frame: yearly for up to 4 years). The study lists 2 primary outcomes in all. 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 NCT00004449, which also lists 3 linked publications.
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 27 May 2015.