Clinical trial NCT01011764: Study of Peer Relationships at School
Official title: Autism Intervention Research Network on Behavior Health (AIR-B): Study of Peer Relationships at School
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autism
Keywords: social networks
friendships
autism spectrum disorder
Lead sponsor: Health Resources and Services Administration (HRSA)
Sponsor class: FED
Collaborators: name: Florida State University
name: Johns Hopkins University
name: University of Michigan
name: University of Washington
First posted: 2009-11-11
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Friendship Survey
timeFrame: Before treatment, after treatment, and 2 months after treatment
Secondary outcomes:
measure: Friendship Qualities Scale
timeFrame: Before treatment, after treatment, and 2 months after treatment
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of California, Los Angeles
name: Connie Kasari, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.