HRSAII: Study of Peer Relationships at School

Sponsor
Health Resources and Services Administration (HRSA) (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01011764
Collaborator
Florida State University (Other), Johns Hopkins University (Other), University of Michigan (Other), University of Washington (Other)
200
5
2
35
40
1.1

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: SKILLS vs ENGAGE
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
200 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Autism Intervention Research Network on Behavior Health (AIR-B): Study of Peer Relationships at School
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Aug 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. The Friendship Survey [Before treatment, after treatment, and 2 months after treatment]

Secondary Outcome Measures

  1. Friendship Qualities Scale [Before treatment, after treatment, and 2 months after treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 University of California, Los Angeles Los Angeles California United States
2 Florida State University Tallahassee Florida United States
3 Kennedy Krieger Institute Baltimore Maryland United States
4 University of Michigan Ann Arbor Michigan United States
5 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

Study Documents (Full-Text)

None provided.

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
Other Study ID Numbers:
  • G09-04-021-01A
  • UA3MC11055
First Posted:
Nov 11, 2009
Last Update Posted:
Aug 16, 2012
Last Verified:
Aug 1, 2012
Keywords provided by Connie Kasari, Ph.D., Professor of Psychological Studies in Education and Psychiatry, Health Resources and Services Administration (HRSA)
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 16, 2012