Study of Peer Relationships at School - Full Text View

Sponsor:	Health Resources and Services Administration (HRSA)
Collaborators:	Florida State University Johns Hopkins University University of Michigan University of Washington
Information provided by:	Health Resources and Services Administration (HRSA)
ClinicalTrials.gov Identifier:	NCT01011764

Purpose

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).

Condition	Intervention
Autism	Behavioral: SKILLS vs ENGAGE

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Autism Intervention Research Network on Behavior Health (AIR-B): Study of Peer Relationships at School

Resource links provided by NLM:

MedlinePlus related topics: Autism

U.S. FDA Resources

Further study details as provided by Health Resources and Services Administration (HRSA):

Primary Outcome Measures:

The Friendship Survey [ Time Frame: Before treatment, after treatment, and 2 months after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Friendship Qualities Scale [ Time Frame: Before treatment, after treatment, and 2 months after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	September 2009
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	September 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.	Behavioral: SKILLS vs ENGAGE 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.
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.	Behavioral: SKILLS vs ENGAGE 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.

Arms

Assigned Interventions

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.

Behavioral: SKILLS vs ENGAGE

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.

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.

Behavioral: SKILLS vs ENGAGE

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.

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.

Eligibility

Ages Eligible for Study:	7 Years to 12 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011764

Contacts

Contact: Connie Kasari, Ph.D.

310-825-8342

kasari@gseis.ucla.edu

Locations

United States, California
University of California, Los Angeles	Recruiting
Los Angeles, California, United States
Contact: Connie Kasari, Ph.D. 310-825-8342 kasari@gseis.ucla.edu
United States, Florida
Florida State University	Recruiting
Tallahassee, Florida, United States
Contact: Amy Wetherby, Ph.D., CCC-SLP 850-644-4367 amy.wetherby@med.fsu.edu
Principal Investigator: Amy Wetherby, Ph.D., CCC-SLP
United States, Maryland
Kennedy Krieger Institute	Recruiting
Baltimore, Maryland, United States
Contact: Rebecca Landa, Ph.D., CCC-SLP 443-923-7551 landa@kennedykrieger.org
Principal Investigator: Rebecca Landa, Ph.D., CCC-SLP
United States, Michigan
University of Michigan	Recruiting
Ann Arbor, Michigan, United States
Contact: Catherine Lord, Ph.D. 734-936-8600 celord@umich.edu
Principal Investigator: Catherine Lord, Ph.D.
United States, Washington
University of Washington	Recruiting
Seattle, Washington, United States
Contact: Bryan King, Ph.D. 206-987-4080 Bhking@u.washington.edu
Principal Investigator: Bryan King, Ph.D.

Sponsors and Collaborators

Health Resources and Services Administration (HRSA)

Florida State University

Johns Hopkins University

University of Michigan

University of Washington

Investigators

Principal Investigator:

Connie Kasari, Ph.D.

University of California, Los Angeles

More Information

Publications:

Bauminger N, Kasari C. Loneliness and friendship in high-functioning children with autism. Child Dev. 2000 Mar-Apr;71(2):447-56.

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.

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.

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.

Responsible Party:	Robin McGrath, Health Resources and Services Administration
ClinicalTrials.gov Identifier:	NCT01011764 History of Changes
Other Study ID Numbers:	G09-04-021-01A, UA3MC11055
Study First Received:	November 10, 2009
Last Updated:	August 9, 2011
Health Authority:	United States: Federal Government

Keywords provided by Health Resources and Services Administration (HRSA):

social networks
friendships
autism spectrum disorder

Additional relevant MeSH terms:

Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on February 09, 2012