Autism Spectrum DisorderTADPOLENCT02272192
Intervention Effects of Intensity and Delivery Style for Toddlers With Autism
A study testing Early Start Denver Model (ESDM) and Early Intensive Behavioral Intervention (EIBI) in people with Autism Spectrum Disorder, run by University of California, Davis at 3 sites in United States.
Trial summary
A multi-site randomized study of intensive treatment for toddlers with autism involving a three-site collaborative network plus a data coordinating center to evaluate the effects of intervention intensity and intervention style delivered for 12 months, on the progress of very young children with ASD ages 12-30 months… Read more about this study
- Who is it for?
- Ages 15 to 30 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Early Start Denver Model (ESDM) and Early Intensive Behavioral Intervention (EIBI)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2013to 1 Jul 2019
- 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 15 to 30 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 12-30 months of age at time of assessment;
- ambulatory and without impairments affecting hand use;
- meets criteria for Autistic Spectrum Disorder on the APA Diagnostic and Statistical Manual, 5th revision criteria and on the Autism Diagnostic Observation Schedule for Toddlers:
- clinical consensus of ASD diagnosis by 2 independent staff (including a licensed psychologist) based on observation as well as record review;
- developmental quotient of >35 on Mullen Scales of Early Learning;
- normal hearing and vision screen;
- caregiver agreement to comply with all project requirements, including regular videotaping at home with provided equipment.
Who cannot join
- English not a primary language spoken at home;
- absence at 2 or more appointments without prior notice during the intake assessment;
- more than 10 hours per week of 1:1 ABA based treatment;
- other health or genetic conditions (i.e. fragile X syndrome, seizures, prematurity).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Vanderbilt University
Nashville, Tennessee, 37240
UC Davis MIND Institute
Sacramento, California, 95817
University of Washington Autism Center
Seattle, Washington, 98195
About this study
A multi-site randomized study of intensive treatment for toddlers with autism involving a three-site collaborative network plus a data coordinating center to evaluate the effects of intervention intensity and intervention style delivered for 12 months, on the progress of very young children with ASD ages 12-30 months old and their families, and the effect of children's developmental rates and autism severity on their response to intervention.
Read the detailed description
High quality, intensive early intervention is a powerful treatment for ASD, improving IQ and language markedly in randomized controlled clinical trials (RCTs), though little long term follow-up data exists. Few core characteristics that affect child change have been tested. Two potential core characteristics that invoke considerable debate among parents, professionals, and administrators are the delivery style of intervention: play-based versus discrete trial teaching, and the intensity (dosage) of intervention. This ACE treatment network conducted an RCTs to answer the following question: what are the effects of intensity and delivery style on developmental progress of toddlers with ASD?
87 young children with ASD, mean age 23.4 months who live within a specified radius near the university at each site were enrolled in one of three national sites and randomized into one of four cells varying on two dimensions: dosage - 15 or 25 hours per week of 1:1 treatment; and discrete trial teaching or naturalistic developmental-behavioral intervention. Other aspects of intervention held constant were: use of the principles of applied behavior analysis, 1:1 adult:child ratios, parent coaching in the assigned treatment, and treatment location. Developmental progress was measured frequently allowing for growth curve analysis to examine fine-grained differences in groups as well as interactions among major child and family initial variables and these two experimental variables.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Early Start Denver Model (ESDM), Early Intensive Behavioral Intervention (EIBI)
- Keywords
- autism, autism spectrum disorder, intensive intervention, early intervention, Early Start Denver Model
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Start Denver Model (ESDM)Behavioural
Also called Naturalistic developmental-behavioral intervention (NDBI)
The Early Start Denver Model (ESDM) is a comprehensive developmental and behavioral early intervention approach for children with autism, ages 12 to 48 months. The program encompasses a developmental curriculum that defines the skills to be taught at any given time and a set of teaching procedures based in applied behavioral analysis to deliver this content. The teaching format focuses on trained therapists delivering the intervention 1:1 by engaging reciprocally with children in typical toddler activities involving play or daily routines, adding additional structure for children who need it to progress well. Progress data is collected throughout each session and used to make decisions about teaching approaches.
Early Intensive Behavioral Intervention (EIBI)Behavioural
Also called ABA, DTT, Lovaas method
EIBI is a one-to-one instructional approach based in applied behavior analysis used to teach skills in a planned, controlled, and systematic manner. Each trial or teaching opportunity has a definite beginning and end, thus the descriptor discrete trial. Within DTT, the use of antecedents and consequences is carefully planned and implemented. Positive praise and/or tangible rewards are used to reinforce desired skills or behaviors. Trial by trial data collection is an important part of DTT and supports decision making by providing teachers/practitioners with information about beginning skill level, progress and challenges, skill acquisition and maintenance, and generalization of learned skills or behaviors.
| Study group | Role | What they receive |
|---|---|---|
| ESDM15 hr/week | Experimental | Children receive 15 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual Receives: Behavioral: Early Start Denver Model (ESDM) |
| ESDM 25 hr/week | Experimental | Children receive 25 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual Receives: Behavioral: Early Start Denver Model (ESDM) |
| EIBI 15 hr/week | Experimental | Children receive 15 hours per week of 1:1 intervention at home plus parent training using Early Intensive Behavioral Intervention (EIBI) and following the Manual "A Work in Progress" Receives: Behavioral: Early Intensive Behavioral Intervention (EIBI) |
| EIBI 25 hr/week | Experimental | Children receive 25 hours per week of 1:1 intervention at home plus parent training using EIBI and following the Manual "A Work in Progress" Receives: Behavioral: Early Intensive Behavioral Intervention (EIBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expressive Communication Composite Score
We used Time 4 means and standard deviations (SDs)s from several measures to compute a z score. The mean of a Z score is always 0 and z scores range from -3 to +3. For this composite a higher score reveals more mature developmental skills. Data from the following measures were used in this composite score: a weighted frequency of intentional communication measured within a 15 minute communication sample; number of different root words measured within the communication sample; the expressive language age equivalent score from he Mullen Scales of Early learning (MSEL); the expressive communication age equivalent scores from the Vineland 2 Adaptive Behavior Scale 2(VABS2); the expressive raw score from the MacArthur Bates Communicative Developmental Inventories; the expressive social communication abilities composite score from the PDD Behavior Inventory; and the expressive language raw score from the PDD Behavior Inventory
Measured: two years
Secondary outcomes (3)
Autism Severity Composite Score
To build the composite scores for all the outcome measures, we first examined whether the proposed component variables were correlated (for 2 component variables) or factor loaded (for 3 or more component variables) at or above .3. We used Time 4 means and SD to compute a z score. The mean of a Z score is always 0 and z scores range from -3 to +3. For this composite a higher score reveals more severe symptoms of ASD. . from the following measures were used in this composite score: the calibrated severity score from the Autism Diagnostic Observation Schedule 2 and the expressive receptive social communication composite from the PDD Behavior Inventory
Measured: two years
Receptive Language Composite Score
To build the composite scores for all the outcome measures, we first examined whether the proposed component variables were correlated (for 2 component variables) or factor loaded (for 3 or more component variables) at or above .3. We used Time 4 means and SD to compute a z score. The mean of a Z score is always 0 and z scores range from -3 to +3. For this composite a higher score reveals more mature developmental skills. from the following measures were used in this composite score: receptive language age equivalent score from the MSEL; receptive language age equivalent score from the VABS 2
Measured: two years
Nonverbal Development Composite Score
To build the composite scores for all the outcome measures, we first examined whether the proposed component variables were correlated (for 2 component variables) or factor loaded (for 3 or more component variables) at or above .3. We used Time 4 means and SD to compute a z score. The mean of a Z score is always 0 and z scores range from -3 to +3. For this composite a higher score reveals more mature developmental skills. from the following measures were used in this composite score: 2 scores - the fine motor and the visual reception age equivalency scores - from the MSEL and 3 age equivalency scores from the VABS2 - daily living, motor skills, and socialization
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2014 (estimated)
- Study startMar 2013
- Primary completion1 Jul 2019
- Study completion1 Jul 2019
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 Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, Vanderbilt University, University of California, Los Angeles
- Responsible party
- Sponsor
- Investigators
- Sally J Rogers, Ph.D., Principal investigator, UC Davis MIND Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272192
- Sponsor's protocol ID
- 406188
- Acronym
- TADPOLE
- Status last verified
- Jan 2020
- First submitted
- 20 Oct 2014
- Last updated
- 6 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: All de-identified data will be uploaded into NDAR as soon as primary papers are published. All demographic data are uploaded into NDAR as they are collected.
Publications
Rogers SJ, Yoder P, Estes A, Warren Z, McEachin J, Munson J, Rocha M, Greenson J, Wallace L, Gardner E, Dawson G, Sugar CA, Hellemann G, Whelan F. A Multisite Randomized Controlled Trial Comparing the Effects of Intervention Intensity and Intervention Style on Outcomes for Young Children With Autism. J Am Acad Child Adolesc Psychiatry. 2021 Jun;60(6):710-722. doi: 10.1016/j.jaac.2020.06.013. Epub 2020 Aug 24.
PubMed 32853704
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Effects of Intensity and Delivery Style for Toddlers With Autism
- ClinicalTrials.gov ID
- NCT02272192
- Acronym / sponsor ID
- TADPOLE / 406188
- Conditions
- Autism Spectrum Disorder
- Keywords
- autism, autism spectrum disorder, intensive intervention, early intervention, Early Start Denver Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- University of Washington, Vanderbilt University, University of California, Los Angeles
- Study start
- Mar 2013
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 22 Oct 2014 (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.
A multi-site randomized study of intensive treatment for toddlers with autism involving a three-site collaborative network plus a data coordinating center to evaluate the effects of intervention intensity and intervention style delivered for 12 months, on the progress of very young children with ASD ages 12-30 months old and their families, and the effect of children's developmental rates and autism severity on their response to intervention.
Detailed description
High quality, intensive early intervention is a powerful treatment for ASD, improving IQ and language markedly in randomized controlled clinical trials (RCTs), though little long term follow-up data exists. Few core characteristics that affect child change have been tested. Two potential core characteristics that invoke considerable debate among parents, professionals, and administrators are the delivery style of intervention: play-based versus discrete trial teaching, and the intensity (dosage) of intervention. This ACE treatment network conducted an RCTs to answer the following question: what are the effects of intensity and delivery style on developmental progress of toddlers with ASD?
87 young children with ASD, mean age 23.4 months who live within a specified radius near the university at each site were enrolled in one of three national sites and randomized into one of four cells varying on two dimensions: dosage - 15 or 25 hours per week of 1:1 treatment; and discrete trial teaching or naturalistic developmental-behavioral intervention. Other aspects of intervention held constant were: use of the principles of applied behavior analysis, 1:1 adult:child ratios, parent coaching in the assigned treatment, and treatment location. Developmental progress was measured frequently allowing for growth curve analysis to examine fine-grained differences in groups as well as interactions among major child and family initial variables and these two experimental variables.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ESDM15 hr/week | Experimental | Behavioral: Early Start Denver Model (ESDM)Children receive 15 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual |
| ESDM 25 hr/week | Experimental | Behavioral: Early Start Denver Model (ESDM)Children receive 25 hours a week of 1:1 intervention at home plus parent coaching using the Early Start Denver Model and following its manual |
| EIBI 15 hr/week | Experimental | Behavioral: Early Intensive Behavioral Intervention (EIBI)Children receive 15 hours per week of 1:1 intervention at home plus parent training using Early Intensive Behavioral Intervention (EIBI) and following the Manual "A Work in Progress" |
| EIBI 25 hr/week | Experimental | Behavioral: Early Intensive Behavioral Intervention (EIBI)Children receive 25 hours per week of 1:1 intervention at home plus parent training using EIBI and following the Manual "A Work in Progress" |
Who may qualify
- Ages
- 15 to 30 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 12-30 months of age at time of assessment;
- ambulatory and without impairments affecting hand use;
- meets criteria for Autistic Spectrum Disorder on the APA Diagnostic and Statistical Manual, 5th revision criteria and on the Autism Diagnostic Observation Schedule for Toddlers:
- clinical consensus of ASD diagnosis by 2 independent staff (including a licensed psychologist) based on observation as well as record review;
- developmental quotient of >35 on Mullen Scales of Early Learning;
Key exclusion criteria (4 listed)
- English not a primary language spoken at home;
- absence at 2 or more appointments without prior notice during the intake assessment;
- more than 10 hours per week of 1:1 ABA based treatment;
- other health or genetic conditions (i.e. fragile X syndrome, seizures, prematurity).
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 Start Denver Model (ESDM)Also: Naturalistic developmental-behavioral intervention (NDBI)The Early Start Denver Model (ESDM) is a comprehensive developmental and behavioral early intervention approach for children with autism, ages 12 to 48 months. The program encompasses a developmental curriculum that defines the skills to be taught at any given time and a set of teaching procedures based in applied behavioral analysis to deliver this content. The teaching format focuses on trained therapists delivering the intervention 1:1 by engaging reciprocally with children in typical toddler activities involving play or daily routines, adding additional structure for children who need it to progress well. Progress data is collected throughout each session and used to make decisions about teaching approaches. | Behavioural | ESDM 25 hr/week, ESDM15 hr/week |
| Early Intensive Behavioral Intervention (EIBI)Also: ABA, DTT, Lovaas methodEIBI is a one-to-one instructional approach based in applied behavior analysis used to teach skills in a planned, controlled, and systematic manner. Each trial or teaching opportunity has a definite beginning and end, thus the descriptor discrete trial. Within DTT, the use of antecedents and consequences is carefully planned and implemented. Positive praise and/or tangible rewards are used to reinforce desired skills or behaviors. Trial by trial data collection is an important part of DTT and supports decision making by providing teachers/practitioners with information about beginning skill level, progress and challenges, skill acquisition and maintenance, and generalization of learned skills or behaviors. | Behavioural | EIBI 15 hr/week, EIBI 25 hr/week |
Primary outcome
Expressive Communication Composite Score
Time frame: two years
We used Time 4 means and standard deviations (SDs)s from several measures to compute a z score. The mean of a Z score is always 0 and z scores range from -3 to +3. For this composite a higher score reveals more mature developmental skills. Data from the following measures were used in this composite score: a weighted frequency of intentional communication measured within a 15 minute communication sample; number of different root words measured within the communication sample; the expressive language age equivalent score from he Mullen Scales of Early learning (MSEL); the expressive communication age equivalent scores from the Vineland 2 Adaptive Behavior Scale 2(VABS2); the expressive raw score from the MacArthur Bates Communicative Developmental Inventories; the expressive social communication abilities composite score from the PDD Behavior Inventory; and the expressive language raw score from the PDD Behavior Inventory
3 secondary outcomes
Autism Severity Composite Score
Time frame: two years
Receptive Language Composite Score
Time frame: two years
Nonverbal Development Composite Score
Time frame: two 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 6 Jan 2020.
- Derived from this study: PubMed 32853704Rogers SJ, Yoder P, Estes A, Warren Z, McEachin J, Munson J, Rocha M, Greenson J, Wallace L, Gardner E, Dawson G, Sugar CA, Hellemann G, Whelan F. A Multisite Randomized Controlled Trial Comparing the Effects of Intervention Intensity and Intervention Style on Outcomes for Young Children With Autism. J Am Acad Child Adolesc Psychiatry. 2021 Jun;60(6):710-722. doi: 10.1016/j.jaac.2020.06.013. Epub 2020 Aug 24.
- Individual participant dataSharing planned: Yes. All de-identified data will be uploaded into NDAR as soon as primary papers are published. All demographic data are uploaded into NDAR as they are collected.
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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.
Sally J Rogers, Ph.D. principal investigator
UC Davis MIND Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Start Denver Model (ESDM) and Early Intensive Behavioral Intervention (EIBI) in people with Autism Spectrum Disorder, run by University of California, Davis at 3 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 7 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 6 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
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?
Expressive Communication Composite Score (time frame: two years). 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 NCT02272192, 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 6 Jan 2020.