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Clinical Trials/NCT01011764
NCT01011764
Completed
Not Applicable

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

Health Resources and Services Administration (HRSA)5 sites in 1 country200 target enrollmentSeptember 2009
ConditionsAutism

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism
Sponsor
Health Resources and Services Administration (HRSA)
Enrollment
200
Locations
5
Primary Endpoint
The Friendship Survey
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
August 2012
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Health Resources and Services Administration (HRSA)
Responsible Party
Principal Investigator
Principal Investigator

Connie Kasari, Ph.D.

Professor of Psychological Studies in Education and Psychiatry

Health Resources and Services Administration (HRSA)

Eligibility Criteria

Inclusion Criteria

  • Children are between the ages of 7 and 12 years in grades 2-
  • 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.

Outcomes

Primary Outcomes

The Friendship Survey

Time Frame: Before treatment, after treatment, and 2 months after treatment

Secondary Outcomes

  • Friendship Qualities Scale(Before treatment, after treatment, and 2 months after treatment)

Study Sites (5)

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