- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01011764
Study of Peer Relationships at School (HRSAII)
August 14, 2012 updated by: Connie Kasari, Ph.D., Health Resources and Services Administration (HRSA)
Autism Intervention Research Network on Behavior Health (AIR-B): Study of Peer Relationships at School
The goal of this study is to compare the effects of two separate, manualized group interventions designed to improve social outcomes for young children with autism.
The first type of group intervention utilizes a social skill curriculum delivered to a small group of children with autism at their school.
This type of group will be referred to as the Skills group (SKILLS intervention).
The other intervention delivers a social engagement curriculum at the children's school site and includes children with autism and typically developing peers, from the same school.
This type of group will be referred to as the School Engagement Group (ENGAGE intervention).
Study Overview
Detailed Description
Once families have decided to join the study, and have completed the informed consent process using the "Social Skills Club - Parent Consent", and once we obtain letters of agreement from participating elementary schools, children with ASD will be randomly assigned to one of two intervention conditions, SKILLS or ENGAGE, led by two trained doctoral students.
Since children will be randomized to either the SKILLS or the ENGAGE group, we are hoping to determine the active ingredients for successfully integrating children with autism.
For both the SKILLS and the ENGAGE groups, all interventions and observations of children will take place in the target child's school.
Thus, upon admission to the project, research personnel will attend the participant's classroom at school, and distribute consent forms titled "Peer Relationships at School - Classroom Parent Consent" to all children in the class.
The consenting process should be no more than ten minutes.
For those children that return informed consent from their parents, as well as offer assent on the "Children's Classroom Assent" to join to the project, social network measures (including brief demographic information), as well as friendship surveys (Friendships Qualities Scale; FQS), and an emotion measure (loneliness questionnaire) will be distributed at pre-intervention (baseline), post-intervention, and follow-up time points.
These measures will take approximately 30-40 minutes per each time point.
Graduate students will administer the measures and will make every effort to do so at a convenient time for the teacher and for the classroom to avoid utilizing instructional time.
In addition, the efficacy of the treatment interventions will be assessed with ongoing direct behavioral observations at entry, twice during treatment, at exit, and at the 2-month follow-up.
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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California
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Los Angeles, California, United States
- University of California, Los Angeles
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Florida
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Tallahassee, Florida, United States
- Florida State University
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Maryland
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Baltimore, Maryland, United States
- Kennedy Krieger Institute
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Michigan
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Ann Arbor, Michigan, United States
- University of Michigan
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Washington
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Seattle, Washington, United States
- University of Washington
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children are between the ages of 7 and 12 years in grades 2-5.
- Children have a clinical diagnosis of autism or PDD-NOS, and/or meet criteria on the ADOS for ASD or autism.
- Children have an IQ of 70 or above
- Children are fully included in a typical classroom for 80% or more of the school day
- Children are expected to stay in the school or the classroom for the duration of the study.
- Families with low SES and/or from racial/ethnic minority backgrounds
Exclusion Criteria:
- Children must not have additional diagnoses or sensory or motor impairments.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: SKILLS group
The SKILLS intervention targets a specific set of social skills over 8 bi-weekly sessions.
The intervention is delivered to a small group of children with autism at school during lunchtime.
The content delivered to the group of young children with autism including lessons developed from a manual by Seattle Children's Hospital Research Foundation.
Children are given weekly homework assignments to reinforce the topics discussed in the group sessions.
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The investigators plan to contrast 2 different models for social skills groups.
Each model involves 16 45-minute bi-weekly sessions, twice a week with a small group of children with ASD.
Details of the 2 intervention models are described below.
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Experimental: ENGAGE group
The ENGAGE intervention targets two social domains, and two learning contexts.
The two social domains are peer acceptance and social engagement with peers.
The social group will be small and include children with ASD as well as their typical peers.
There will be a greater number of typical peers included to model social behaviors and foster friendships.
The typical peers will be selected based on results from the friendship survey and teacher nominations.
The two learning contexts are direct instruction in a group social skills format during lunchtime and individualized embedded generalization activities in the school day.
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The investigators plan to contrast 2 different models for social skills groups.
Each model involves 16 45-minute bi-weekly sessions, twice a week with a small group of children with ASD.
Details of the 2 intervention models are described below.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The Friendship Survey
Time Frame: Before treatment, after treatment, and 2 months after treatment
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Before treatment, after treatment, and 2 months after treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Friendship Qualities Scale
Time Frame: Before treatment, after treatment, and 2 months after treatment
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Before treatment, after treatment, and 2 months after treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Connie Kasari, Ph.D., University of California, Los Angeles
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bauminger N, Kasari C. Loneliness and friendship in high-functioning children with autism. Child Dev. 2000 Mar-Apr;71(2):447-56. doi: 10.1111/1467-8624.00156.
- Chamberlain B, Kasari C, Rotheram-Fuller E. Involvement or isolation? The social networks of children with autism in regular classrooms. J Autism Dev Disord. 2007 Feb;37(2):230-42. doi: 10.1007/s10803-006-0164-4.
- Kasari C, Freeman SF, Bauminger N, Alkin MC. Parental perspectives on inclusion: effects of autism and Down syndrome. J Autism Dev Disord. 1999 Aug;29(4):297-305. doi: 10.1023/a:1022159302571.
- Robertson K, Chamberlain B, Kasari C. General education teachers' relationships with included students with autism. J Autism Dev Disord. 2003 Apr;33(2):123-30. doi: 10.1023/a:1022979108096.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
August 1, 2012
Study Registration Dates
First Submitted
November 10, 2009
First Submitted That Met QC Criteria
November 10, 2009
First Posted (Estimate)
November 11, 2009
Study Record Updates
Last Update Posted (Estimate)
August 16, 2012
Last Update Submitted That Met QC Criteria
August 14, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- G09-04-021-01A
- UA3MC11055 (Other Grant/Funding Number: Health Resources and Services Administration)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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