Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Institute of Mental Health (NIMH) |
---|---|
Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00760812 |
This study will compare the effectiveness of two parent-based programs for helping young children at risk of autism.
Condition | Intervention |
---|---|
Autistic Disorder |
Behavioral: Early Social Interaction Project- PII Behavioral: Early Social Interaction Project- IES |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Crossover Assignment, Efficacy Study |
Official Title: | Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum (The ESI Study) |
Estimated Enrollment: | 100 |
Study Start Date: | April 2007 |
Estimated Study Completion Date: | January 2013 |
Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
This group will first receive the Early Social Interaction Project parent-implemented intervention (PII) for 9 months, followed by the Early Social Interaction Project information, education, and support (IES) intervention for 9 months.
|
Behavioral: Early Social Interaction Project- PII
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.
Behavioral: Early Social Interaction Project- IES
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.
|
2: Experimental
The group will first receive IES for 9 months, followed by PII for 9 months.
|
Behavioral: Early Social Interaction Project- PII
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.
Behavioral: Early Social Interaction Project- IES
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.
|
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.
Ages Eligible for Study: | 16 Months to 20 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
United States, Florida | |
Florida State University | Recruiting |
Tallahassee, Florida, United States, 32306 | |
Contact: Lindee Morgan, PhD 850-488-4830 lindee.morgan@med.fsu.edu | |
Contact: Laura Newton 850-488-5780 laura.newton@med.fsu.edu | |
Principal Investigator: Amy M. Wetherby, PhD | |
United States, Michigan | |
University of Michigan | Recruiting |
Ann Arbor, Michigan, United States, 48109 | |
Contact: Julie McCormick, MA 734-764-4048 mccormj@umich.edu | |
Principal Investigator: Catherine Lord, PhD |
Principal Investigator: | Amy M. Wetherby, PhD | Florida State University |
Principal Investigator: | Catherine Lord, PhD | University of Michigan |
Responsible Party: | Florida State University ( Amy M. Wetherby, Professor and Principal Investigator ) |
Study ID Numbers: | R01 MH077730, 1R01MH077730-01A2, 1R01MH078165-01A2, DDTR B2-MBA |
Study First Received: | September 25, 2008 |
Last Updated: | October 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00760812 |
Health Authority: | United States: Federal Government |
Autism Autism Spectrum Disorders Pervasive Developmental Disorders Toddlers Intervention |
Child Development Disorders, Pervasive Developmental Disabilities Mental Disorders Autistic Disorder Mental Disorders Diagnosed in Childhood |
Pathologic Processes Disease |