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Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Florida State University
ClinicalTrials.gov Identifier:
NCT00760812
First received: September 25, 2008
Last updated: February 19, 2014
Last verified: February 2014

September 25, 2008
February 19, 2014
April 2007
May 2013   (final data collection date for 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 ] [ Designated as safety issue: No ]
Child measures of autism symptoms, social communication, developmental level and adaptive behavior [ Time Frame: Measured before treatment, at crossover, and after treatment, with some of these measures also being taken every other month ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00760812 on ClinicalTrials.gov Archive Site
Parent report measures of family functioning, daily hassles, and treatment satisfaction [ Time Frame: Measured before treatment, at crossover, and after treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Autistic Disorder
  • 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: 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.
    Interventions:
    • Behavioral: Early Social Interaction Project- PII
    • Behavioral: Early Social Interaction Project- IES
  • Experimental: 2
    The group will first receive IES for 9 months, followed by PII for 9 months.
    Interventions:
    • Behavioral: Early Social Interaction Project- PII
    • Behavioral: Early Social Interaction Project- IES
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
82
January 2014
May 2013   (final data collection date for primary outcome measure)

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
Both
16 Months to 20 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00760812
R01 MH077730, R01MH077730, 1R01MH077730-01A2, 1R01MH078165-01A2, DDTR B2-MBA
Yes
Florida State University
Florida State University
National Institute of Mental Health (NIMH)
Principal Investigator: Amy M. Wetherby, PhD Florida State University
Principal Investigator: Catherine Lord, PhD University of Michigan
Florida State University
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP