What is the purpose of this study?

Dr. Annette Estes and researchers at the University of Washington want to learn more about outcomes for very young children who are showing early signs of autism. The information gained in this study may improve methods of intervention for infants who may be at risk for developing autism and lead to better outcome for these young children and their families.

In conjunction with researchers at the University of California - Davis and the University of Michigan at Ann Arbor, researchers at the University of Washington will assess infants participating in this study. Families who qualify for the study will be seen for up to 4 sets of evaluations over the course of 2.5 years. We will monitor all children over the course of the study and be able to give references for resources in the community. All qualifying families will be randomized into two groups. We randomize families because sometimes when there is a new intervention we want to know if it is better, worse or as good as treatment available in the community. Therefore some families will receive a UW provided intervention and some will be able to choose any intervention available in the greater Seattle community.

Families in the UW provided intervention will begin with a 12 week parent training where a main caregiver and the child will attend weekly sessions at the University of Washington. If families still qualify for the study after the 12 week parent training, families in the UW provided treatment will be given 20 hours a week of in home intervention for two years offered by UW trained therapists.

Families in the Assessment and Monitoring group will be given references to services in the greater Seattle area. They will be able to choose which therapy the wish from the services that are available to them.

All families will be seen for the 4 evaluations during the duration of the study (2.5 years). We will be able to provide feedback as to each child's progress and be able to go over each child's strengths and weaknesses with parents.

How can I participate? What are the criteria?

Your child can participate if:

• He or she is 12-24 months old and has symptoms of autism (a diagnosis is not required)
• Your family lives within 30 minutes driving of the University of Washington
• He or she has English as one primary language, has normal hearing and vision and is not currently enrolled in intensive behavioral treatment

What is the time commitment for participation in the study?

The initial phone call will take about 45 minutes to determine if the study is a good match for your family. If your family passed the phone screening there will be two assessment visits and a feedback visit to the UW Autism Center. If your family qualifies for the study we will also see your child at 3 additional time points. Visits to the Autism Center will typically take 1.5 - 2 hours. Roughly 13 weeks after your first set of visits you will be asked to come into the university for another evaluation. Evaluations will occur one and two years later also. Your family will be asked to fill out a packet of questionnaires which will take about 2 hours to complete at each evaluation time point (4 total).

Some families will also receive training in a parent-delivered intervention requiring weekly visits to the UW Autism Center for 12 weeks. These visits are approximately 1.5 hours in length and occur once a week for the 12 weeks. Parents are required to attend these visits with their children. Some families will also have the possibility of receiving intensive in home intervention for 2 years following their 12 week training. The in home intervention is provided by UW trained therapists and is approximately 20 hours a week. This too requires that a caregiver be in the home with the child during 20 therapy hours (daytime M-F) each week and that parents commit to using these strategies learned in sessions throughout the week. This intervention requires a high level of parent participation.

What will my family [my child or I] get out of the study?

Families who participate will benefit by receiving feedback from a clinical psychologist as to their child's current developmental level, strengths, and challenges as well as monitoring of their development for two years. We will provide you with recommendations for services (Speech Therapy, etc) that best fit your child according to the evaluations we complete. In addition, some of the infants will receive free intervention.

What are the risks to participating in this study and what safeguards are in place to minimize any risks?

All efforts are made to minimize any potential risks. There are no known psychological or physical risks associated with any of the procedures. Additionally, all researchers at the University of Washington Autism Center are very experienced in working with children with autism and their families.

For those families in the UW treatment group, the parent training component of treatment may be initially uncomfortable. Your interactions with your child will be observed and we will make specific suggestions to change your interactions with your infant. The goal of the intervention, however, is to improve social and communication skills between you and your child and should increase the comfort within this relationship. It might also be initially uncomfortable to have intervention therapists come to your home.

Who are the investigators involved in this project?

University of Washington site:
Principal Investigator: Annette Estes, Ph.D.
Assessment Team Director: Jessica Greenson, Ph.D.
Treatment Team Director: Jamie M. Winter, Ph.D.
Project Coordinator & Clinician: Lauren Elder, M.S.
Scheduling Coordinator: Emilie Dupont

UC Davis MIND site:
Principal Investigators: Sally Rogers, Ph.D., Sally Ozonoff, Ph.D.

University of Michigan at Ann Arbor site:
Principal Investigator: Cathy Lord, Ph.D.

Whom should I contact to get involved?

To learn more about any of our studies, please contact our Project Scheduler at our toll-free number: 1-800-994-9701

University of Washington
Early Steps Study
Box 357920, Seattle, WA 98195
phone: 1-800-994-9701
email: ddrinfo@u.washington.edu

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