Study of Peer Relationships at School

NCT ID: NCT01011764

Last Updated: 2012-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-08-31

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.

Conditions

Autism

Keywords

social networks; friendships; autism spectrum disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

SKILLS vs ENGAGE

Intervention Type: BEHAVIORAL

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.

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.

Group Type: EXPERIMENTAL

SKILLS vs ENGAGE

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida State University

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: collaborator

Health Resources and Services Administration (HRSA)

FED

Sponsor Role: lead

Responsible Party

Connie Kasari, Ph.D.

Professor of Psychological Studies in Education and Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Connie Kasari, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Locations

University of California, Los Angeles

Los Angeles, California, United States

Florida State University

Tallahassee, Florida, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

University of Michigan

Ann Arbor, Michigan, United States

University of Washington

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 10834476 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 16855874 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10478729 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12757351 (View on PubMed)

Other Identifiers

UA3MC11055

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

G09-04-021-01A

Identifier Type: -

Identifier Source: org_study_id