Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders
Primary Purpose
Autistic Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early Social Interaction Project- PII
Early Social Interaction Project- IES
Sponsored by
About this trial
This is an interventional treatment trial for Autistic Disorder focused on measuring Autism, Autism Spectrum Disorders, Pervasive Developmental Disorders, Toddlers, Intervention
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Florida State University
- University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
ESI--Individual PII First Condition
ESI--Group IES First Condition
Arm Description
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.
The group will first receive ESI group IES condition for 9 months, followed by ESI individual PII for 9 months.
Outcomes
Primary Outcome Measures
Child measures of autism symptoms, social communication, developmental level, and adaptive behavior
Secondary Outcome Measures
Parent report measures of family functioning, daily hassles, and treatment satisfaction
Full Information
NCT ID
NCT00760812
First Posted
September 25, 2008
Last Updated
July 25, 2022
Sponsor
Florida State University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT00760812
Brief Title
Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders
Official Title
Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum (The ESI Study)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Florida State University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autism, Autism Spectrum Disorders, Pervasive Developmental Disorders, Toddlers, Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ESI--Individual PII First Condition
Arm Type
Experimental
Arm Description
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.
Arm Title
ESI--Group IES First Condition
Arm Type
Experimental
Arm Description
The group will first receive ESI group IES condition for 9 months, followed by ESI individual PII for 9 months.
Intervention Type
Behavioral
Intervention Name(s)
Early Social Interaction Project- PII
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Early Social Interaction Project- IES
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Parent report measures of family functioning, daily hassles, and treatment satisfaction
Time Frame
Measured before treatment, at crossover, and after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Months
Maximum Age & Unit of Time
20 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy M. Wetherby, PhD
Organizational Affiliation
Florida State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Catherine Lord, PhD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32306
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25367544
Citation
Wetherby 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.
Results Reference
derived
Learn more about this trial
Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders
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