Comparing Parent-Implemented Interventions for Toddlers With Autism Spectrum Disorders
Condition: Autistic Disorder
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional

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.
    

Intervention name(s): Early Social Interaction Project- PII; Early Social Interaction Project- IES
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.; 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Autism Spectrum Disorders; Pervasive Developmental Disorders; Toddlers; Intervention