Autistic DisorderNCT00760812
Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders
A study testing Early Social Interaction Project- PII and Early Social Interaction Project- IES in people with Autistic Disorder, run by Florida State University at 2 sites in United States.
Trial summary
This study will compare the effectiveness of two parent-based programs for helping young children at risk of autism. Read more about this study
- Who is it for?
- Ages 16 to 20 months
- Conditions the study is for
- Autistic Disorder
- What is being tested?
- Early Social Interaction Project- PII and Early Social Interaction Project- IES
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2007to Jan 2014
- 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 16 to 20 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of autism risk factors and a clinical diagnosis of autism spectrum disorder based on a diagnostic evaluation conducted by the project team
- Families agree to twice monthly play group sessions for 9 months and two to three intervention sessions per week for 9 months, usually to be scheduled within workday hours
- Families agree to monthly evaluations, videotaping of intervention sessions, and weekly or monthly video checks during the 18 months of treatment
Who cannot join
- Child does not have normal hearing or adequate motor control to make simple actions, such as giving and reaching gestures
- Primary language of family is not English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan
Ann Arbor, Michigan, 48109
Florida State University
Tallahassee, Florida, 32306
About this study
Official title: Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum (The ESI Study)
This study will compare the effectiveness of two parent-based programs for helping young children at risk of autism.
Read the detailed description
Autism is a problem with normal social development and is characterized by impairments in three categories: social skills, language, and behavior. Symptoms include disinterest or inability to have normal social relationships, abnormal speech or usage of phrases, and repetitive movements or rituals; these symptoms generally emerge by 18 months of age. Autism is a spectrum disorder, meaning that its symptoms can range in severity from mild to severe. There is no cure for autism, nor is there a single known cause. There are only factors known to make it more likely for children to develop autism. These include being a male, having siblings with the disorder, having certain other disorders, or having an older father. Treatments for autism generally include therapies that help children develop social communication skills and that help structure family time and school so that parents and teachers can address particular difficulties children with autism might have. Medications may also be used to counteract anxieties or compulsive behaviors.
Research has shown that earlier interventions in children who are at risk of autism may lead to better outcomes. This study will compare two interventions for developing social communication skills in children who are at risk of autism and are between 16 and 20 months old. The parent-implemented intervention (PII) will be a more intense, individualized approach, teaching parents to embed 25 hours of social communication skills practice per week in their children's daily lives. The information, education, and support (IES) intervention will offer parents a support group and place to practice methods of helping their children learn adaptive social communication.
Participation in this study will last 18 months. Participants will be randomly assigned to first receive 9 months of either PII or IES and then receive 9 months of whichever intervention they did not receive initially. The PII intervention will involve three weekly sessions for 7 months, then two weekly sessions for 2 months. The IES intervention will involve group meetings twice monthly and offer a playground where parents can practice intervention strategies with their children. All parents will complete questionnaires about family resources and social and emotional issues before the first intervention begins, after 9 months when the intervention changes, and after 18 months when the second intervention ends. Children and parents will also be assessed once a month throughout the study on social communication, autism symptoms, developmental level, and hours spent on learned strategies or techniques outside the study visits. These assessments will involve clinical assessments of parent and child behaviors (some of which will be videotaped), tests of children's abilities, and reports by parents on strategies and techniques used outside the clinic.
- Conditions
- Autistic Disorder
- Being tested
- Early Social Interaction Project- PII, Early Social Interaction Project- IES
- Keywords
- Autism, Autism Spectrum Disorders, Pervasive Developmental Disorders, Toddlers, Intervention
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder, Child Development Disorders, Pervasive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Social Interaction Project- PIIBehavioural
The PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places. Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study. Participants will then have two sessions per week for the final 2 months of the study. Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits.
Early Social Interaction Project- IESBehavioural
The IES intervention provides access to a support group meeting twice monthly for children with autism and their parents. The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders.
| Study group | Role | What they receive |
|---|---|---|
| ESI--Individual PII First Condition | Experimental | This group will first receive the Early Social Interaction (ESI) model individual parent-implemented intervention (PII) for 9 months, followed by the ESI model group information, education, and support (IES) intervention for 9 months. Receives: Behavioral: Early Social Interaction Project- PII; Behavioral: Early Social Interaction Project- IES |
| ESI--Group IES First Condition | Experimental | The group will first receive ESI group IES condition for 9 months, followed by ESI individual PII for 9 months. Receives: Behavioral: Early Social Interaction Project- PII; Behavioral: Early Social Interaction Project- IES |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior
Measured: Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month
Secondary outcomes (1)
Parent report measures of family functioning, daily hassles, and treatment satisfaction
Measured: Measured before treatment, at crossover, and after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startApr 2007
- Primary completionMay 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 Florida State 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Amy M. Wetherby, Florida State University
- Investigators
- Amy M. Wetherby, PhD, Principal investigator, Florida State UniversityCatherine Lord, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760812
- Sponsor's protocol ID
- R01MH077730
- Other IDs
- R01MH077730, 1R01MH077730-01A2, 1R01MH078165-01A2, DDTR B2-MBA
- Status last verified
- Feb 2014
- First submitted
- 25 Sep 2008
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Brown H, Swain D, Kim HW, Rogers S, Estes A, Kasari C, Lord C, Kim SH. Examining variability in Naturalistic Developmental Behavioral Intervention strategy use in caregivers of children with autism spectrum disorders. J Child Psychol Psychiatry. 2025 Jan;66(1):4-15. doi: 10.1111/jcpp.13994. Epub 2024 May 8.
PubMed 38719439Wetherby AM, Guthrie W, Woods J, Schatschneider C, Holland RD, Morgan L, Lord C. Parent-implemented social intervention for toddlers with autism: an RCT. Pediatrics. 2014 Dec;134(6):1084-93. doi: 10.1542/peds.2014-0757. Epub 2014 Nov 3.
PubMed 25367544
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum (The ESI Study)
- ClinicalTrials.gov ID
- NCT00760812
- Acronym / sponsor ID
- R01MH077730
- Conditions
- Autistic Disorder
- Keywords
- Autism, Autism Spectrum Disorders, Pervasive Developmental Disorders, Toddlers, Intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2007
- Primary completion
- May 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 26 Sep 2008 (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 compare the effectiveness of two parent-based programs for helping young children at risk of autism.
Detailed description
Autism is a problem with normal social development and is characterized by impairments in three categories: social skills, language, and behavior. Symptoms include disinterest or inability to have normal social relationships, abnormal speech or usage of phrases, and repetitive movements or rituals; these symptoms generally emerge by 18 months of age. Autism is a spectrum disorder, meaning that its symptoms can range in severity from mild to severe. There is no cure for autism, nor is there a single known cause. There are only factors known to make it more likely for children to develop autism. These include being a male, having siblings with the disorder, having certain other disorders, or having an older father. Treatments for autism generally include therapies that help children develop social communication skills and that help structure family time and school so that parents and teachers can address particular difficulties children with autism might have. Medications may also be used to counteract anxieties or compulsive behaviors.
Research has shown that earlier interventions in children who are at risk of autism may lead to better outcomes. This study will compare two interventions for developing social communication skills in children who are at risk of autism and are between 16 and 20 months old. The parent-implemented intervention (PII) will be a more intense, individualized approach, teaching parents to embed 25 hours of social communication skills practice per week in their children's daily lives. The information, education, and support (IES) intervention will offer parents a support group and place to practice methods of helping their children learn adaptive social communication.
Participation in this study will last 18 months. Participants will be randomly assigned to first receive 9 months of either PII or IES and then receive 9 months of whichever intervention they did not receive initially. The PII intervention will involve three weekly sessions for 7 months, then two weekly sessions for 2 months. The IES intervention will involve group meetings twice monthly and offer a playground where parents can practice intervention strategies with their children. All parents will complete questionnaires about family resources and social and emotional issues before the first intervention begins, after 9 months when the intervention changes, and after 18 months when the second intervention ends. Children and parents will also be assessed once a month throughout the study on social communication, autism symptoms, developmental level, and hours spent on learned strategies or techniques outside the study visits. These assessments will involve clinical assessments of parent and child behaviors (some of which will be videotaped), tests of children's abilities, and reports by parents on strategies and techniques used outside the clinic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESI--Individual PII First Condition | Experimental | Behavioral: Early Social Interaction Project- PII, Behavioral: Early Social Interaction Project- IESThis group will first receive the Early Social Interaction (ESI) model individual parent-implemented intervention (PII) for 9 months, followed by the ESI model group information, education, and support (IES) intervention for 9 months. |
| ESI--Group IES First Condition | Experimental | Behavioral: Early Social Interaction Project- PII, Behavioral: Early Social Interaction Project- IESThe group will first receive ESI group IES condition for 9 months, followed by ESI individual PII for 9 months. |
Who may qualify
- Ages
- 16 to 20 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Presence of autism risk factors and a clinical diagnosis of autism spectrum disorder based on a diagnostic evaluation conducted by the project team
- Families agree to twice monthly play group sessions for 9 months and two to three intervention sessions per week for 9 months, usually to be scheduled within workday hours
- Families agree to monthly evaluations, videotaping of intervention sessions, and weekly or monthly video checks during the 18 months of treatment
Key exclusion criteria (2 listed)
- Child does not have normal hearing or adequate motor control to make simple actions, such as giving and reaching gestures
- Primary language of family is not English
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 Social Interaction Project- PIIThe PII is an intensive, individualized treatment that teaches parents how to support social communication skills in children with autism by embedding skills practice within everyday routines, activities, and places. Participants will have three 75-minute sessions weekly with study administrators for the first 7 months of the study. Participants will then have two sessions per week for the final 2 months of the study. Children will also practice socialization embedded in normal activities for 25 hours a week outside of study visits. | Behavioural | ESI--Group IES First Condition, ESI--Individual PII First Condition |
| Early Social Interaction Project- IESThe IES intervention provides access to a support group meeting twice monthly for children with autism and their parents. The support group provides information to families and a playgroup where parents may practice intervention strategies under the supervision of study officials knowledgeable about autism spectrum disorders. | Behavioural | ESI--Group IES First Condition, ESI--Individual PII First Condition |
Primary outcome
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior
Time frame: Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month
1 secondary outcome
Parent report measures of family functioning, daily hassles, and treatment satisfaction
Time frame: Measured before treatment, at crossover, and after treatment
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 Jul 2022.
- Derived from this study: PubMed 38719439Brown H, Swain D, Kim HW, Rogers S, Estes A, Kasari C, Lord C, Kim SH. Examining variability in Naturalistic Developmental Behavioral Intervention strategy use in caregivers of children with autism spectrum disorders. J Child Psychol Psychiatry. 2025 Jan;66(1):4-15. doi: 10.1111/jcpp.13994. Epub 2024 May 8.
- Derived from this study: PubMed 25367544Wetherby AM, Guthrie W, Woods J, Schatschneider C, Holland RD, Morgan L, Lord C. Parent-implemented social intervention for toddlers with autism: an RCT. Pediatrics. 2014 Dec;134(6):1084-93. doi: 10.1542/peds.2014-0757. Epub 2014 Nov 3.
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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.
Amy M. Wetherby, PhD principal investigator
Florida State University
Catherine Lord, PhD principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Social Interaction Project- PII and Early Social Interaction Project- IES in people with Autistic Disorder, run by Florida State University at 2 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 3 inclusion and 2 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 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior (time frame: Measured before treatment, at crossover, and after treatment; some of these measures also will be taken every other month). 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 NCT00760812, which also lists 2 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 Jul 2022.