Autism Spectrum DisordersNCT01985022
Changing Developmental Trajectories Through Early Treatment
A study testing Group-ESI and Individual-ESI in people with Autism Spectrum Disorders, run by Emory University at 1 site in United States.
Trial summary
The major objective of this research protocol is to directly compare two parent intervention conditions of Early Social Interaction (ESI) for 9 months on developmental trajectories of infants showing early risk for Autism Spectrum Disorder (ASD). Read more about this study
- Who is it for?
- Ages 9 to 24 months
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Group-ESI and Individual-ESI
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- May 2013to 26 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 9 to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants are recruited from the Emory Autism Center of Excellence Center from a pool of younger siblings who are at high or low risk of developing ASD
- For high-risk infants, a positive screen on 2 of 4 screening measures indicating the presence of diagnostic features of ASD by 12 months of age
- For low-risk infants will be a positive screen on 3 of 4 screening measures
- Families agree to twice monthly play group sessions for 9 months and 2-3 intervention sessions per week for 9 months (usually within work-day hours)
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Autism Center of Excellence: Project 3 - Changing Developmental Trajectories Through Early Treatment
The major objective of this research protocol is to directly compare two parent intervention conditions of Early Social Interaction (ESI) for 9 months on developmental trajectories of infants showing early risk for Autism Spectrum Disorder (ASD). Participants will be randomized to receive an information, education and support group (Group) ESI intervention offered weekly, or a parent-implemented intervention (Individual) ESI intervention offered in twice-weekly, in combination with the Group ESI intervention.
Read the detailed description
Mounting evidence exists of the effectiveness of intensive early intervention for a substantial proportion of children with autism spectrum disorders (ASD). Furthermore, age of entry into intervention may be predictive of outcome. Children with ASD in intensive interventions beginning by 3.5 years of age had significantly better outcomes than those beginning after age 5. These findings support the importance of early identification and intervention for improving outcomes. There is very limited research on children with ASD under 3 years of age primarily because the median age for diagnosis in the US is 5.5 years. With advances in earlier screening and diagnosis, there is a pressing need to develop early intervention programs that are appropriate and effective with very young children with ASD.
The Early Social Interaction (ESI) Project is an intervention program developed for toddlers at risk for ASD and their families as a model demonstration project funded by the United States Department of Education. ESI was designed to incorporate the National Research Council (NRC) recommendations within the context of a family-centered, natural-environments approach. The major components of ESI are:
- routines-based intervention in natural environments
- individualized curriculum
- parent-implemented intervention
The Emory Autism Center of Excellence (ACE) will recruit parent-infant dyads at 12 months of infant's age from a pool of "High-Risk for Developing ASD" younger siblings and from a pool of low risk infants being studied at the Emory ACE. Parents are involved in the intervention itself while the study outcome measures are focused on the infants that are receiving the different interventions (demographic and outcome data are not collected on the parents of the infants). Infant participants will be randomized to receive an ESI intervention delivered in a group setting, or an individual ESI intervention combined with the group ESI. The intervention will last 9 months and infants will be followed until they reach 36 months of age.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Group-ESI, Individual-ESI
- Keywords
- autism, pervasive developmental disorders, toddlers, behavioral intervention
- Medical subject headings
- Autism Spectrum Disorder, Autistic Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group-ESIBehavioural
The Group-ESI intervention consists of weekly small group meetings where families receive information about social communication, emotional regulation, play development, and behavioral challenges in toddler playgroups in a relaxed, supportive, child-friendly setting that provides the opportunity to talk with a professional and meet other parents.
Individual-ESIBehavioural
The Individual-ESI intervention consists of twice-weekly home-based individualized coaching sessions. Parents learn how to support their child's communication, social, and play skills in everyday routines, activities, and places. Individual-ESI begins with an initial home visit, followed by a month of program planning, 6 months of intervention implementation, and 2 months of generalization. During generalization, the clinician meets with the family in a variety of community settings to teach the parent how to implement strategies in new settings.
| Study group | Role | What they receive |
|---|---|---|
| Group-ESI | Active comparator | Infants 12 months of age at risk of developing ASD who are randomized to receive the Group-ESI intervention for 9 months. Receives: Behavioral: Group-ESI |
| Individual-ESI plus Group-ESI | Experimental | Infants 12 months of age at risk of developing ASD who are randomized to receive Individual-ESI intervention in addition to the Group-ESI intervention for 9 months. Receives: Behavioral: Group-ESI; Behavioral: Individual-ESI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Communication and Symbolic Behavior Scales (CSBS) Score
Social communication skills were measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver were videotaped and later converted to scores. The standardized total score has a mean of 100 and standard deviation of 15. Scores below 100 indicate below average performance with the social, speech, and symbolic composites.
Measured: Baseline (12 months of age, prior to treatment), 15, 21, and 24 months of age
Autism Diagnostic Observation Schedule (ADOS) Score
Autism symptoms were measured with the Autism Diagnostic Observation Schedule, Second Edition which is the best gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms were used. A total of score of 1 to 3 indicates no signs of autism, a score of 4 or 5 suggests that the child may have autism spectrum disorder, while a score of 6 to 10 is indicative of autism.
Measured: 15, 24, and 36 months of age
Mullen Scales of Early Learning (MSEL) Score
The Mullen Scales of Early Learning (MSEL) measures developmental level with standardized scores in five domains: Visual Reception, Receptive Language, Expressive Language, Fine Motor Skills, and Gross Motor Skills. Domain scores are represented in T-scores, with a mean of 50 and standard deviation of 10. A Verbal Composite score is calculated by averaging T-scores of the domains for Receptive and Expressive Language. A Nonverbal Composite score is calculated by averaging T-scores for Visual Reception and Fine Motor domains. Scores below 50 indicate below average performance.
Measured: Baseline (12 months of age, prior to treatment), 24, and 36 months of age
Vineland Adaptive Behavior Scales, Second Edition (Vineland II) Score
The Vineland II assesses adaptive behavior by providing a standard score in four domains of Communication, Daily Living Skills, Socialization, and Motor Skills. Domain scores and the Adaptive Behavior Composite score are standardized with a mean of 100 with a standard deviation of 15. Scores less than 100 indicate below average performance.
Measured: Baseline (12 months of age, prior to treatment), 24, and 36 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2013 (estimated)
- Study startMay 2013
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Why it stopped: Participant enrollment was hindered by the COVID-19 pandemic and the study was ultimately terminated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nathan A. Call, Emory University
- Investigators
- Nathan Call, PhD, Principal investigator, Emory University, Marcus Autism Center, Children's Healthcare of AtlantaAmy Wetherby, Ph.D., Study director, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01985022
- Sponsor's protocol ID
- IRB00064779
- Other IDs
- P50MH100029
- Status last verified
- May 2023
- First submitted
- 5 Nov 2013
- Last updated
- 9 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Center of Excellence: Project 3 - Changing Developmental Trajectories Through Early Treatment
- ClinicalTrials.gov ID
- NCT01985022
- Acronym / sponsor ID
- IRB00064779
- Conditions
- Autism Spectrum Disorders
- Keywords
- autism, pervasive developmental disorders, toddlers, behavioral intervention
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Participant enrollment was hindered by the COVID-19 pandemic and the study was ultimately terminated.
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- May 2013 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 15 Nov 2013 (estimated)
- Results
- Posted 9 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The major objective of this research protocol is to directly compare two parent intervention conditions of Early Social Interaction (ESI) for 9 months on developmental trajectories of infants showing early risk for Autism Spectrum Disorder (ASD). Participants will be randomized to receive an information, education and support group (Group) ESI intervention offered weekly, or a parent-implemented intervention (Individual) ESI intervention offered in twice-weekly, in combination with the Group ESI intervention.
Detailed description
Mounting evidence exists of the effectiveness of intensive early intervention for a substantial proportion of children with autism spectrum disorders (ASD). Furthermore, age of entry into intervention may be predictive of outcome. Children with ASD in intensive interventions beginning by 3.5 years of age had significantly better outcomes than those beginning after age 5. These findings support the importance of early identification and intervention for improving outcomes. There is very limited research on children with ASD under 3 years of age primarily because the median age for diagnosis in the US is 5.5 years. With advances in earlier screening and diagnosis, there is a pressing need to develop early intervention programs that are appropriate and effective with very young children with ASD.
The Early Social Interaction (ESI) Project is an intervention program developed for toddlers at risk for ASD and their families as a model demonstration project funded by the United States Department of Education. ESI was designed to incorporate the National Research Council (NRC) recommendations within the context of a family-centered, natural-environments approach. The major components of ESI are:
- routines-based intervention in natural environments
- individualized curriculum
- parent-implemented intervention
The Emory Autism Center of Excellence (ACE) will recruit parent-infant dyads at 12 months of infant's age from a pool of "High-Risk for Developing ASD" younger siblings and from a pool of low risk infants being studied at the Emory ACE. Parents are involved in the intervention itself while the study outcome measures are focused on the infants that are receiving the different interventions (demographic and outcome data are not collected on the parents of the infants). Infant participants will be randomized to receive an ESI intervention delivered in a group setting, or an individual ESI intervention combined with the group ESI. The intervention will last 9 months and infants will be followed until they reach 36 months of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-ESI | Active comparator | Behavioral: Group-ESIInfants 12 months of age at risk of developing ASD who are randomized to receive the Group-ESI intervention for 9 months. |
| Individual-ESI plus Group-ESI | Experimental | Behavioral: Group-ESI, Behavioral: Individual-ESIInfants 12 months of age at risk of developing ASD who are randomized to receive Individual-ESI intervention in addition to the Group-ESI intervention for 9 months. |
Who may qualify
- Ages
- 9 to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Participants are recruited from the Emory Autism Center of Excellence Center from a pool of younger siblings who are at high or low risk of developing ASD
- For high-risk infants, a positive screen on 2 of 4 screening measures indicating the presence of diagnostic features of ASD by 12 months of age
- For low-risk infants will be a positive screen on 3 of 4 screening measures
- Families agree to twice monthly play group sessions for 9 months and 2-3 intervention sessions per week for 9 months (usually within work-day hours)
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Group-ESIThe Group-ESI intervention consists of weekly small group meetings where families receive information about social communication, emotional regulation, play development, and behavioral challenges in toddler playgroups in a relaxed, supportive, child-friendly setting that provides the opportunity to talk with a professional and meet other parents. | Behavioural | Group-ESI, Individual-ESI plus Group-ESI |
| Individual-ESIThe Individual-ESI intervention consists of twice-weekly home-based individualized coaching sessions. Parents learn how to support their child's communication, social, and play skills in everyday routines, activities, and places. Individual-ESI begins with an initial home visit, followed by a month of program planning, 6 months of intervention implementation, and 2 months of generalization. During generalization, the clinician meets with the family in a variety of community settings to teach the parent how to implement strategies in new settings. | Behavioural | Individual-ESI plus Group-ESI |
Primary outcome
Communication and Symbolic Behavior Scales (CSBS) Score
Time frame: Baseline (12 months of age, prior to treatment), 15, 21, and 24 months of age
Social communication skills were measured with the Communication and Symbolic Behavior Scales (CSBS) Behavior Sample. Interactions between the child and caregiver were videotaped and later converted to scores. The standardized total score has a mean of 100 and standard deviation of 15. Scores below 100 indicate below average performance with the social, speech, and symbolic composites.
Autism Diagnostic Observation Schedule (ADOS) Score
Time frame: 15, 24, and 36 months of age
Autism symptoms were measured with the Autism Diagnostic Observation Schedule, Second Edition which is the best gold standard diagnostic measure of ASD. The revised algorithms forming Social-Affect and Restricted Repetitive Behavior ratings of autism symptoms were used. A total of score of 1 to 3 indicates no signs of autism, a score of 4 or 5 suggests that the child may have autism spectrum disorder, while a score of 6 to 10 is indicative of autism.
Mullen Scales of Early Learning (MSEL) Score
Time frame: Baseline (12 months of age, prior to treatment), 24, and 36 months of age
The Mullen Scales of Early Learning (MSEL) measures developmental level with standardized scores in five domains: Visual Reception, Receptive Language, Expressive Language, Fine Motor Skills, and Gross Motor Skills. Domain scores are represented in T-scores, with a mean of 50 and standard deviation of 10. A Verbal Composite score is calculated by averaging T-scores of the domains for Receptive and Expressive Language. A Nonverbal Composite score is calculated by averaging T-scores for Visual Reception and Fine Motor domains. Scores below 50 indicate below average performance.
Vineland Adaptive Behavior Scales, Second Edition (Vineland II) Score
Time frame: Baseline (12 months of age, prior to treatment), 24, and 36 months of age
The Vineland II assesses adaptive behavior by providing a standard score in four domains of Communication, Daily Living Skills, Socialization, and Motor Skills. Domain scores and the Adaptive Behavior Composite score are standardized with a mean of 100 with a standard deviation of 15. Scores less than 100 indicate below average performance.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Nathan Call, PhD principal investigator
Emory University, Marcus Autism Center, Children's Healthcare of Atlanta
Amy Wetherby, Ph.D. study director
Florida State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group-ESI and Individual-ESI in people with Autism Spectrum Disorders, run by Emory University 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 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 9 Jun 2023. 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?
Yes. Results are posted in the registry (first posted 9 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Communication and Symbolic Behavior Scales (CSBS) Score (time frame: Baseline (12 months of age, prior to treatment), 15, 21, and 24 months of age). The study lists 4 primary outcomes in all. 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 9 Jun 2023.