NCT01011764

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2009

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 10, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 11, 2009

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 16, 2012

Status Verified

August 1, 2012

Enrollment Period

2.8 years

First QC Date

November 10, 2009

Last Update Submit

August 14, 2012

Conditions

Keywords

social networksfriendshipsautism spectrum disorder

Outcome Measures

Primary Outcomes (1)

  • The Friendship Survey

    Before treatment, after treatment, and 2 months after treatment

Secondary Outcomes (1)

  • Friendship Qualities Scale

    Before treatment, after treatment, and 2 months after treatment

Study Arms (2)

SKILLS group

ACTIVE COMPARATOR

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

ENGAGE group

EXPERIMENTAL

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

Interventions

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.

ENGAGE groupSKILLS group

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Children must not have additional diagnoses or sensory or motor impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

University of California, Los Angeles

Los Angeles, California, United States

Location

Florida State University

Tallahassee, Florida, United States

Location

Kennedy Krieger Institute

Baltimore, Maryland, United States

Location

University of Michigan

Ann Arbor, Michigan, United States

Location

University of Washington

Seattle, Washington, United States

Location

Related Publications (4)

  • 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.

    PMID: 10834476BACKGROUND
  • 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.

    PMID: 16855874BACKGROUND
  • 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.

    PMID: 10478729BACKGROUND
  • 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.

    PMID: 12757351BACKGROUND

MeSH Terms

Conditions

Autistic DisorderAutism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Connie Kasari, Ph.D.

    University of California, Los Angeles

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychological Studies in Education and Psychiatry

Study Record Dates

First Submitted

November 10, 2009

First Posted

November 11, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

August 16, 2012

Record last verified: 2012-08

Locations