Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| P50MH100029 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Participant enrollment was hindered by the COVID-19 pandemic and the study was ultimately terminated.
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
Not provided
Not provided
Not provided
Not provided
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.
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:
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group-ESI | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Expressive Language Phase | The child's expressive language phase will be determined at each assessment based on the benchmarks delineated by Tager-Flusberg and colleagues and recommended for evaluating the efficacy and comparing outcomes across NIH-funded intervention studies. Based on multiple sources of information about language benchmarks, the language will be categorized as: Preverbal Communication, First Words, Word Combinations, or Sentences, to provide a clinically meaningful measure of language outcome. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nathan Call, PhD | Emory University, Marcus Autism Center, Children's Healthcare of Atlanta | Principal Investigator |
| Amy Wetherby, Ph.D. | Florida State University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marcus Autism Center | Atlanta | Georgia | 30329 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Infants were enrolled with a parent as parents were a necessary part of the intervention that the infants received. Parents are not considered to be participants who received a study intervention, thus, only infants are described in the modules for Participant Flow, Baseline Characteristics, Outcome Measures, and Adverse Events.
Participants were recruited from Marcus Autism Center in Atlanta, Georgia, USA. Participant enrollment began in May 2013 and follow-up was completed by November 26, 2019.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group-Early Social Interaction (ESI) | Infants 12 months of age at risk of developing autism spectrum disorders (ASD) who were randomized to receive the Group-Early Social Interaction (ESI) intervention for 9 months |
| FG001 | Individual-ESI Plus Group-ESI | Infants 12 months of age at risk of developing ASD who were randomized to receive Individual-ESI intervention in addition to the Group-ESI intervention for 9 months. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group-ESI | Infants 12 months of age at risk of developing ASD who were randomized to receive the Group-ESI intervention for 9 months |
| BG001 | Individual-ESI Plus Group-ESI | Infants 12 months of age at risk of developing ASD who were randomized to receive Individual-ESI intervention in addition to the Group-ESI intervention for 9 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | This analysis includes participants remaining in the study at the indicated time point who also completed this assessment. Due to scheduling conflicts with families, not all participants were able to complete every study assessment. If a study visit could not be scheduled within the visit window then that visit was skipped and the next assessment was scheduled. | Posted | Mean | Standard Deviation | score on a scale | Baseline (12 months of age, prior to treatment), 15, 21, and 24 months of age |
|
Information on adverse events was collected beginning at the baseline assessment and continued through the final assessment (up to 36 months of age).
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group-ESI | Infants 12 months of age at risk of developing ASD who were randomized to receive the Group-ESI intervention for 9 months |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathan Call, PhD | Emory University | 404-785-9400 | nathan.call@choa.org |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 19, 2020 | Nov 21, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 18, 2018 | Sep 21, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| D001321 | Autistic Disorder |
| D002659 | Child Development Disorders, Pervasive |
| ID | Term |
|---|---|
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Individual-ESI | Behavioral | 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. |
|
| Baseline (12 months of age, prior to treatment), 24, and 36 months of age |
| Baseline (12 months of age, prior to treatment), 15, 21, 24, and 36 months of age |
| Withdrawal by Subject |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Infants 12 months of age at risk of developing ASD who were randomized to receive the Group-ESI intervention for 9 months |
| OG001 | Individual-ESI Plus Group-ESI | Infants 12 months of age at risk of developing ASD who were randomized to receive Individual-ESI intervention in addition to the Group-ESI intervention for 9 months. |
|
|
| Primary | 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. | This analysis includes participants remaining in the study at the indicated time point who also completed this assessment. Due to scheduling conflicts with families, not all participants were able to complete every study assessment. If a study visit could not be scheduled within the visit window then that visit was skipped and the next assessment was scheduled. | Posted | Mean | Standard Deviation | score on a scale | 15, 24, and 36 months of age |
|
|
|
| Primary | 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. | This analysis includes participants remaining in the study at the indicated time point who also completed this assessment. Due to scheduling conflicts with families, not all participants were able to complete every study assessment. If a study visit could not be scheduled within the visit window then that visit was skipped and the next assessment was scheduled. | Posted | Mean | Standard Deviation | t-score | Baseline (12 months of age, prior to treatment), 24, and 36 months of age |
|
|
|
| Primary | 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. | This analysis includes participants remaining in the study at the indicated time point who also completed this assessment. Due to scheduling conflicts with families, not all participants were able to complete every study assessment. If a study visit could not be scheduled within the visit window then that visit was skipped and the next assessment was scheduled. | Posted | Mean | Standard Deviation | score on a scale | Baseline (12 months of age, prior to treatment), 24, and 36 months of age |
|
|
|
| Other Pre-specified | Expressive Language Phase | The child's expressive language phase will be determined at each assessment based on the benchmarks delineated by Tager-Flusberg and colleagues and recommended for evaluating the efficacy and comparing outcomes across NIH-funded intervention studies. Based on multiple sources of information about language benchmarks, the language will be categorized as: Preverbal Communication, First Words, Word Combinations, or Sentences, to provide a clinically meaningful measure of language outcome. | Expressive language phase was to be coded based on the CSBS, however, this coding requires extensive time and effort by a trained staff member. As the study terminated early and research priorities shifted with the Coronavirus disease 2019 (COVID-19) pandemic, staffing was no longer available to review the video recordings specifically to code language phase. Data analyses for this study focused on addressing the primary aims of the study and data for this outcome were never created. | Posted | Baseline (12 months of age, prior to treatment), 15, 21, 24, and 36 months of age |
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Individual-ESI Plus Group-ESI | Infants 12 months of age at risk of developing ASD who were randomized to receive Individual-ESI intervention in addition to the Group-ESI intervention for 9 months. | 0 | 17 | 0 | 17 | 0 | 17 |
Not provided
Not provided
Not provided
| 24 Months of Age |
|
|
| 36 Months of Age |
|
|
| 24 Months of Age - Verbal Composite Score |
|
|
| 36 Months of Age - Verbal Composite Score |
|
|
| Baseline (12 months of age, prior to treatment) - Nonverbal Composite Score |
|
|
| 24 Months of Age - Nonverbal Composite Score |
|
|
| 36 Months of Age - Nonverbal Composite Score |
|
|
| 24 Months of Age |
|
|
| 36 Months of Age |
|
|