Autistic DisorderNCT00106210
School- and Home-Based Early Intervention for Toddlers With Autism
A study testing Early intervention blending several tx approaches, w/ focus and Early intervention blending several treatment approaches in people with Autistic Disorder and Autism, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site in United States.
Trial summary
This study will determine the impact of early intervention on the communication and social development of toddlers with autism. Read more about this study
- Who is it for?
- Ages 18 to 33 months
- Conditions the study is for
- Autistic Disorder, Autism
- What is being tested?
- Early intervention blending several tx approaches, w/ focus and Early intervention blending several treatment approaches
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- May 2003to Sep 2007
- 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 18 to 33 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of autism spectrum disorder
- Parent or guardian willing to give informed consent for child's participation
- Developmental level above 9 months on the Visual Reception Scale of the Mullen Scales of Early Learning and on the Adaptive Behavior Composite of the Vineland Adaptive Behavior Scales
- English is primary language for child and family
Who cannot join
- Evidence of vision or hearing impairment
- Diagnosis of fragile X syndrome, Rett syndrome, tuberous sclerosis, neurofibromatosis, phenylketonuria, or congenital rubella
- History of severe birth trauma or traumatic brain injury
- Siblings with autism spectrum disorder
Trial locations and contacts
1 site in 1 country.
United States1 site
Kennedy Krieger Institute
Baltimore, Maryland, 21211
About this study
Official title: Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
This study will determine the impact of early intervention on the communication and social development of toddlers with autism.
Read the detailed description
Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism.
Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention.
- Conditions
- Autistic Disorder, Autism
- Being tested
- Early intervention blending several tx approaches, w/ focus, Early intervention blending several treatment approaches
- Keywords
- Child
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early intervention blending several tx approaches, w/ focusBehavioural
Early intervention blending several different treatment approaches, with a focus on certain skills
Early intervention blending several treatment approachesBehavioural
Early intervention blending several different treatment approaches
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Behavioral Intervention (experimental) Receives: Behavioral: Early intervention blending several tx approaches, w/ focus |
| 2 | Active comparator | Behavioral Intervention 2 Receives: Behavioral: Early intervention blending several treatment approaches |
What is being measured
The primary outcome is the main question the study is designed to answer.
Receptive language skills
Measured: Pre-tx, Post-tx, and 6 month follow up
Expressive language skills
Measured: Pre-tx, Post-tx, and 6 month follow up
Secondary outcomes (3)
Social cognitive skills
Measured: Pre-tx, Post-tx, and 6 month follow up
Social emotional functioning
Measured: Pre-tx, Post-tx, and 6 month follow up
Play skills
Measured: Pre-tx, Post-tx, and 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2005 (estimated)
- Study startMay 2003
- Primary completionSep 2007
- Study completionSep 2007
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 Autistic DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Rebecca Landa, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
- Investigators
- Rebecca Landa, PhD, Principal investigator, Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00106210
- Sponsor's protocol ID
- U54MH066417
- Other IDs
- U54MH066417, DDTR BD-DD
- Status last verified
- Jul 2013
- First submitted
- 21 Mar 2005
- Last updated
- 8 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Landa RJ, Holman KC, O'Neill AH, Stuart EA. Intervention targeting development of socially synchronous engagement in toddlers with autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2011 Jan;52(1):13-21. doi: 10.1111/j.1469-7610.2010.02288.x. Epub 2010 Dec 3.
PubMed 21126245
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection, Intervention, and Neurobiology in Autism: Early Intervention Portion
- ClinicalTrials.gov ID
- NCT00106210
- Acronym / sponsor ID
- U54MH066417
- Conditions
- Autistic Disorder, Autism
- Keywords
- Child
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Hugo W. Moser Research Institute at Kennedy Krieger, Inc.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2003
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 22 Mar 2005 (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.
This study will determine the impact of early intervention on the communication and social development of toddlers with autism.
Detailed description
Autism is a condition that affects brain development, often leading to difficulties in social, emotional, and educational functioning. This study will determine whether early intervention can improve such functioning in toddlers with autism.
Each treatment session will last 6 months. Children with an autism spectrum disorder will be enrolled in one of two parallel classes and will receive one of two treatments 4 days a week for the duration of the session. Children in each class will receive the same amount and level of intervention, but with a different goal focus. Treatments will be school- and home-based; parents will receive instruction on administering the at-home part of the treatment. The intervention will include environmental engineering, developmental approaches, adaptations of traditional behavioral approaches, and contemporary behavioral approaches that apply principles of applied behavior analysis in more naturalistic teaching frameworks. A series of measures including scales, interviews, and observations will be used to assess the children at baseline, study completion, and 6 months after study completion. The children will be videotaped during the school-based intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Early intervention blending several tx approaches, w/ focusBehavioral Intervention (experimental) |
| 2 | Active comparator | Behavioral: Early intervention blending several treatment approachesBehavioral Intervention 2 |
Who may qualify
- Ages
- 18 to 33 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Diagnosis of autism spectrum disorder
- Parent or guardian willing to give informed consent for child's participation
- Developmental level above 9 months on the Visual Reception Scale of the Mullen Scales of Early Learning and on the Adaptive Behavior Composite of the Vineland Adaptive Behavior Scales
- English is primary language for child and family
Key exclusion criteria (4 listed)
- Evidence of vision or hearing impairment
- Diagnosis of fragile X syndrome, Rett syndrome, tuberous sclerosis, neurofibromatosis, phenylketonuria, or congenital rubella
- History of severe birth trauma or traumatic brain injury
- Siblings with autism spectrum disorder
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 |
|---|---|---|
| Early intervention blending several tx approaches, w/ focusEarly intervention blending several different treatment approaches, with a focus on certain skills | Behavioural | 1 |
| Early intervention blending several treatment approachesEarly intervention blending several different treatment approaches | Behavioural | 2 |
Primary outcome
Receptive language skills
Time frame: Pre-tx, Post-tx, and 6 month follow up
Expressive language skills
Time frame: Pre-tx, Post-tx, and 6 month follow up
3 secondary outcomes
Social cognitive skills
Time frame: Pre-tx, Post-tx, and 6 month follow up
Social emotional functioning
Time frame: Pre-tx, Post-tx, and 6 month follow up
Play skills
Time frame: Pre-tx, Post-tx, and 6 month follow up
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 8 Jul 2013.
- Derived from this study: PubMed 21126245Landa RJ, Holman KC, O'Neill AH, Stuart EA. Intervention targeting development of socially synchronous engagement in toddlers with autism spectrum disorder: a randomized controlled trial. J Child Psychol Psychiatry. 2011 Jan;52(1):13-21. doi: 10.1111/j.1469-7610.2010.02288.x. Epub 2010 Dec 3.
- Click here for the Center for Autism and Related Disorders (CARD) at the Kennedy Krieger Institute Web siteLink provided by the sponsor.
- Click here for the Autism and Neuro-Psychiatric Disorders Research at the Kennedy Krieger Institute Web siteLink 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.
Rebecca Landa, PhD principal investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early intervention blending several tx approaches, w/ focus and Early intervention blending several treatment approaches in people with Autistic Disorder and Autism, run by Hugo W. Moser Research Institute at Kennedy Krieger, Inc. at 1 site 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 4 inclusion and 4 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 8 Jul 2013. 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 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.
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?
Receptive language skills (time frame: Pre-tx, Post-tx, and 6 month follow up). 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 NCT00106210, 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 8 Jul 2013; AzTrials last refreshed its copy on 6 Nov 2026.