Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study will compare the effectiveness of two parent-based programs for helping young children at risk of autism.

Condition or disease	Intervention/treatment	Phase
Autistic Disorder	Behavioral: Early Social Interaction Project- PII; Behavioral: Early Social Interaction Project- IES	Not Applicable

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	82 participants
Allocation:	Randomized
Intervention Model:	Crossover Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Effects of Parent-Implemented Intervention for Toddlers With Autism Spectrum (The ESI Study)
Study Start Date :	April 2007
Actual Primary Completion Date :	May 2013
Actual Study Completion Date :	January 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 1; 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.
Experimental: 2; 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.

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Measures :

1. Parent report measures of family functioning, daily hassles, and treatment satisfaction [ Time Frame: Measured before treatment, at crossover, and after treatment ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	16 Months to 20 Months (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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
• Normal hearing and adequate motor control to make simple actions, such as giving and reaching
• 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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Florida
Florida State University
Tallahassee, Florida, United States, 32306
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

Florida State University

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:	Amy M. Wetherby, PhD	Florida State University
Principal Investigator:	Catherine Lord, PhD	University of Michigan

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Florida State University
ClinicalTrials.gov Identifier:	NCT00760812 History of Changes
Other Study ID Numbers:	R01MH077730 ( U.S. NIH Grant/Contract ); 1R01MH077730-01A2 ( U.S. NIH Grant/Contract ); 1R01MH078165-01A2 ( U.S. NIH Grant/Contract ); DDTR B2-MBA
First Posted:	September 26, 2008
Last Update Posted:	February 20, 2014
Last Verified:	February 2014

Keywords provided by Florida State University:

Autism; Autism Spectrum Disorders; Pervasive Developmental Disorders; Toddlers; Intervention

Additional relevant MeSH terms:

Disease; Autism Spectrum Disorder; Autistic Disorder; Pathologic Processes	Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders