Autism Spectrum DisorderNCT02680015
Understanding the Effects of Intervention on the Brain in Autism
A study testing PEERS in people with Autism Spectrum Disorder and Asperger Disorder, run by Marquette University at 1 site in United States.
Trial summary
This study examines how the PEERS (Laugeson \& Frankel, 2010; Laugeson, 2016) social-behavioral intervention affects social relationships and brain development and function in autistic preschoolers, adolescents, and young adults. Read more about this study
- Who is it for?
- Ages 4 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder, Asperger Disorder, PDD-NOS
- What is being tested?
- PEERS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to May 2023
- 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 4 to 28 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Verbal, speaking in full sentences
- Meets ASD criteria
- Meets IQ criteria >70
Who cannot join
- schizophrenia or bipolar disorder
Trial locations and contacts
1 site in 1 country.
About this study
This study examines how the PEERS (Laugeson \& Frankel, 2010; Laugeson, 2016) social-behavioral intervention affects social relationships and brain development and function in autistic preschoolers, adolescents, and young adults.
- Conditions
- Autism Spectrum Disorder, Asperger Disorder, PDD-NOS, Autism
- Being tested
- PEERS
- Keywords
- PEERS, friendships, brain
- Medical subject headings
- Autism Spectrum Disorder, Asperger Syndrome, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEERSBehavioural
Also called Program for the Education and Enrichment of Relational Skills
Social-behavioral intervention designed to help individuals with Autism Spectrum Disorder make and keep friends.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Immediate enrollment in the PEERS group. Receives: Behavioral: PEERS |
| Waitlist Group | No intervention | Research measures while waiting for PEERS; will receive PEERS within one year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness Scale (SRS: Constantino, 2005)
Questionnaire completed by caregivers on social function and autism symptoms. Will be aggregated by group; no individual reports will be used.
Measured: within two weeks of PEERS completion
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Questionnaire completed by participants with Autism Spectrum Disorder. Measures knowledge of the PEERS intervention concepts. Will be aggregated by group; no individual reports will be used.
Measured: within two weeks of PEERS completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startAug 2010
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Vaughan Van Hecke, Marquette University
- Investigators
- Amy Van Hecke, PhD, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680015
- Sponsor's protocol ID
- HR 2020
- Status last verified
- Apr 2023
- First submitted
- 4 Feb 2016
- Last updated
- 19 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Effects of Intervention on the Brain in Autism
- ClinicalTrials.gov ID
- NCT02680015
- Acronym / sponsor ID
- HR 2020
- Conditions
- Autism Spectrum Disorder, Asperger Disorder, PDD-NOS, Autism
- Keywords
- PEERS, friendships, brain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 11 Feb 2016 (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.
This study examines how the PEERS (Laugeson \& Frankel, 2010; Laugeson, 2016) social-behavioral intervention affects social relationships and brain development and function in autistic preschoolers, adolescents, and young adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: PEERSImmediate enrollment in the PEERS group. |
| Waitlist Group | No intervention | –Research measures while waiting for PEERS; will receive PEERS within one year. |
Who may qualify
- Ages
- 4 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Verbal, speaking in full sentences
- Meets ASD criteria
- Meets IQ criteria >70
Key exclusion criteria (1 listed)
- schizophrenia or bipolar disorder
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 |
|---|---|---|
| PEERSAlso: Program for the Education and Enrichment of Relational SkillsSocial-behavioral intervention designed to help individuals with Autism Spectrum Disorder make and keep friends. | Behavioural | Experimental Group |
Primary outcome
Social Responsiveness Scale (SRS: Constantino, 2005)
Time frame: within two weeks of PEERS completion
Questionnaire completed by caregivers on social function and autism symptoms. Will be aggregated by group; no individual reports will be used.
Test of Adolescent Social SKills (TASSK: Laugeson & Frankel, 2010)
Time frame: within two weeks of PEERS completion
Questionnaire completed by participants with Autism Spectrum Disorder. Measures knowledge of the PEERS intervention concepts. Will be aggregated by group; no individual reports will be used.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2023.
- Individual participant dataSharing planned: No
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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.
Amy Van Hecke, PhD principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEERS in people with Autism Spectrum Disorder and Asperger Disorder, run by Marquette University at 1 site 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 3 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: status not confirmed, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Social Responsiveness Scale (SRS: Constantino, 2005) (time frame: within two weeks of PEERS completion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2023.