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Study of Peer Relationships at School (HRSAII)

Primary Purpose

Autism

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SKILLS vs ENGAGE
Sponsored by
Health Resources and Services Administration (HRSA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autism focused on measuring social networks, friendships, autism spectrum disorder

Eligibility Criteria

7 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of California, Los Angeles
  • Florida State University
  • Kennedy Krieger Institute
  • University of Michigan
  • University of Washington

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SKILLS group

ENGAGE group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The Friendship Survey

Secondary Outcome Measures

Friendship Qualities Scale

Full Information

First Posted
November 10, 2009
Last Updated
August 14, 2012
Sponsor
Health Resources and Services Administration (HRSA)
Collaborators
Florida State University, Johns Hopkins University, University of Michigan, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT01011764
Brief Title
Study of Peer Relationships at School
Acronym
HRSAII
Official Title
Autism Intervention Research Network on Behavior Health (AIR-B): Study of Peer Relationships at School
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Resources and Services Administration (HRSA)
Collaborators
Florida State University, Johns Hopkins University, University of Michigan, University of Washington

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism
Keywords
social networks, friendships, autism spectrum disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SKILLS group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
ENGAGE group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
SKILLS vs ENGAGE
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Friendship Survey
Time Frame
Before treatment, after treatment, and 2 months after treatment
Secondary Outcome Measure Information:
Title
Friendship Qualities Scale
Time Frame
Before treatment, after treatment, and 2 months after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Connie Kasari, Ph.D.
Organizational Affiliation
University of California, Los Angeles
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
Country
United States
Facility Name
Florida State University
City
Tallahassee
State/Province
Florida
Country
United States
Facility Name
Kennedy Krieger Institute
City
Baltimore
State/Province
Maryland
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10834476
Citation
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.
Results Reference
background
PubMed Identifier
16855874
Citation
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.
Results Reference
background
PubMed Identifier
10478729
Citation
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.
Results Reference
background
PubMed Identifier
12757351
Citation
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.
Results Reference
background

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Study of Peer Relationships at School

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