AutismHRSAIINCT01011764
Study of Peer Relationships at School
A study testing SKILLS vs ENGAGE in people with Autism, run by Health Resources and Services Administration (HRSA) at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Autism
- What is being tested?
- SKILLS vs ENGAGE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2009to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Children must not have additional diagnoses or sensory or motor impairments.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Michigan
Ann Arbor, Michigan
Kennedy Krieger Institute
Baltimore, Maryland
University of California, Los Angeles
Los Angeles, California
University of Washington
Seattle, Washington
Florida State University
Tallahassee, Florida
About this study
Official title: Autism Intervention Research Network on Behavior Health (AIR-B): Study of Peer Relationships at School
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).
Read the 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.
- Conditions
- Autism
- Being tested
- SKILLS vs ENGAGE
- Keywords
- social networks, friendships, autism spectrum disorder
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SKILLS vs ENGAGEBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: SKILLS vs ENGAGE |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Friendship Survey
Measured: Before treatment, after treatment, and 2 months after treatment
Secondary outcomes (1)
Friendship Qualities Scale
Measured: Before treatment, after treatment, and 2 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AutismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Health Resources and Services Administration (HRSA)
- Sponsor type
- US federal agency
- Collaborators
- Florida State University, Johns Hopkins University, University of Michigan, University of Washington
- Responsible party
- Principal investigator, Connie Kasari, Ph.D., Health Resources and Services Administration (HRSA)
- Investigators
- Connie Kasari, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01011764
- Sponsor's protocol ID
- G09-04-021-01A
- Other IDs
- UA3MC11055
- Acronym
- HRSAII
- Status last verified
- Aug 2012
- First submitted
- 10 Nov 2009
- Last updated
- 16 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10834476Chamberlain 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.
PubMed 16855874Kasari 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.
PubMed 10478729Robertson 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.
PubMed 12757351
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autism Intervention Research Network on Behavior Health (AIR-B): Study of Peer Relationships at School
- ClinicalTrials.gov ID
- NCT01011764
- Acronym / sponsor ID
- HRSAII / G09-04-021-01A
- Conditions
- Autism
- Keywords
- social networks, friendships, autism spectrum disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Health Resources and Services Administration (HRSA)US federal agency
- Collaborators
- Florida State University, Johns Hopkins University, University of Michigan, University of Washington
- Study start
- Sep 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 11 Nov 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SKILLS group | Active comparator | Behavioral: SKILLS vs ENGAGEThe 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. |
| ENGAGE group | Experimental | Behavioral: SKILLS vs ENGAGEThe 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. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (1 listed)
- Children must not have additional diagnoses or sensory or motor impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SKILLS vs ENGAGEThe 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. | Behavioural | ENGAGE group, SKILLS group |
Primary outcome
The Friendship Survey
Time frame: Before treatment, after treatment, and 2 months after treatment
1 secondary outcome
Friendship Qualities Scale
Time frame: Before treatment, after treatment, and 2 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2012.
- Background: PubMed 10834476Bauminger 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.
- Background: PubMed 16855874Chamberlain 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.
- Background: PubMed 10478729Kasari 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.
- Background: PubMed 12757351Robertson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Connie Kasari, Ph.D. principal investigator
University of California, Los Angeles
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SKILLS vs ENGAGE in people with Autism, run by Health Resources and Services Administration (HRSA) at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Friendship Survey (time frame: Before treatment, after treatment, and 2 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01011764, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2012; AzTrials last refreshed its copy on 31 Oct 2026.