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Study of Peer Relationships at School (HRSAII)

This study has been completed.
Sponsor:
Collaborators:
Florida State University
Johns Hopkins University
University of Michigan
University of Washington
Information provided by (Responsible Party):
Connie Kasari, Ph.D., Health Resources and Services Administration (HRSA)
ClinicalTrials.gov Identifier:
NCT01011764
First received: November 10, 2009
Last updated: August 14, 2012
Last verified: August 2012
  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:


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 ]

Enrollment: 200
Study Start Date: September 2009
Study Completion Date: August 2012
Primary Completion Date: June 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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States
United States, Florida
Florida State University
Tallahassee, Florida, United States
United States, Maryland
Kennedy Krieger Institute
Baltimore, Maryland, United States
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States
United States, Washington
University of Washington
Seattle, Washington, United States
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:
Responsible Party: Connie Kasari, Ph.D., Professor of Psychological Studies in Education and Psychiatry, Health Resources and Services Administration (HRSA)
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 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Health Resources and Services Administration (HRSA):
social networks
friendships
autism spectrum disorder

ClinicalTrials.gov processed this record on November 20, 2014