Study of Peer Relationships at School

Autism Clinical Trial

— HRSAII  

Official title:

Autism Intervention Research Network on Behavior Health (AIR-B): Study of Peer Relationships at School

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01011764
• Other study ID #: G09-04-021-01A
• Secondary ID: UA3MC11055
• Status: Completed
• Phase: N/A
• First received: November 10, 2009
• Last updated: August 14, 2012
• Start date: September 2009
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• Source: Health Resources and Services Administration (HRSA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 12 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Autism

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Kennedy Krieger Institute	Baltimore	Maryland
United States	University of California, Los Angeles	Los Angeles	California
United States	University of Washington	Seattle	Washington
United States	Florida State University	Tallahassee	Florida

Sponsors (5)

Lead Sponsor	Collaborator
Health Resources and Services Administration (HRSA)	Florida State University, Johns Hopkins University, University of Michigan, University of Washington

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Friendship Survey		Before treatment, after treatment, and 2 months after treatment	No
Secondary	Friendship Qualities Scale		Before treatment, after treatment, and 2 months after treatment	No