Autism Spectrum DisordersNCT02995564
The Multi-Media Social Skills Project for Adults
A study testing social skills therapy in people with Autism Spectrum Disorders, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study is investigating the development of a social skills training program for adults with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal Investigator for this study is Dr. Michael Murray, the director of the Autism Studies Division at the Penn State Hershey Medical Center. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- social skills therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to 9 Apr 2018
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18 and 35 years of age
- Must be a Pennsylvania resident
- A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the SRS-2
- A verbal IQ of 85 or above on the Kaufman Brief Intelligence Test, Second Edition
- English as primary language spoken
- Ability to fluently speak in full sentences
Who cannot join
- A significant language delay
- Difficulty with aggression directed at peers
- A primary thought disorder
- A secondary disorder of anxiety or depression so severe as to prevent the individual's participation in the treatment
- A current high school student at start of intervention
- Low social motivation demonstrated through formalized assessment and/or by responses given to screening interview
Trial locations and contacts
1 site in 1 country.
United States1 site
The Pennsylvania Psychiatric Institute Northeast Drive Clinic
Hershey, Pennsylvania, 17033
About this study
Official title: The Multi-Media Social Skills Project for Adults: Validation of an Intervention for Adults With Autism Spectrum Disorders
This study is investigating the development of a social skills training program for adults with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal Investigator for this study is Dr. Michael Murray, the director of the Autism Studies Division at the Penn State Hershey Medical Center. The purpose of this study is to adapt a social skills training program to address and enhance the social skills of adults with Asperger's Syndrome and high-functioning autism.
Read the detailed description
During group study visits, a group of six young adults with Asperger's Syndrome or high-functioning autism will meet weekly for about 90 minutes. The purpose of the group sessions is to work on everyday social skills such as initiating and maintaining conversations, establishing friendships, and dealing with situations such as job interviews and dating.
A generalization session will be held every week after the group therapy session with same-age peers who have been screened to participate in the study. The purpose of including peers in the class is to give young adults with Asperger's syndrome and high-functioning autism a chance to practice the social skills learned in the group study visit with a peer group. Study participants will be paired with a typically developing peer for an outing in the community to a nearby restaurant or shop or an in-class exercise such as a mock job interview.
- Conditions
- Autism Spectrum Disorders
- Being tested
- social skills therapy
- Keywords
- Social Skills, Asperger's, High-functioning autism, Young adults
- Medical subject headings
- Autism Spectrum Disorder, Social Skills
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
social skills therapyBehavioural
Sixteen week manual based social skills curriculum targeting social fluency and responsiveness.
| Study group | Role | What they receive |
|---|---|---|
| Social Skills Intervention | Experimental | The intervention is a 16-week social skills therapy program that will consist of a 90 minute group therapy session followed by a 90 minute peer generalization session meeting once per week. Each cohort will consist of 6 adolescents with Aspergers or high-functioning autism, who will be joined by 6 typically-developing peers for the peer generalization portion. During the group therapy session young adults will discuss and watch video clips addressing social skills topics relevant to their age group. They will have a chance to practice these skills when paired with typically developing peer volunteers. Receives: Behavioral: social skills therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Responsiveness Scale - Adult
The Social Responsiveness Scale - Adult is used to measure levels of social awareness, cognition, communication, motivation, and autistic mannerisms in adults.
Measured: One week post-intervention
Video recording of Social Interaction
Participants will be filmed in a brief interaction with a typically developing peer which will be coded to obtain social interaction skills and fluency scores.
Measured: One week post-intervention
Secondary outcomes (15)
Achenbach Adult Behavior Checklist
The Achenbach is a 126-item survey that asks about behaviors, problems, and substance use.
Measured: One week post-intervention
Social and Emotional Loneliness Scale for Adults (SELSA)
The SELSA is a 37-item survey that assesses friendships and other relationships.
Measured: one week post-intervention
Social Skills Inventory (SSI)
The SSI is a 90-item survey that measures social competence.
Measured: one week post-intervention
Social Phobia Inventory (SPIN)
The SPIN is a 17-item survey that asks about feelings in social situations.
Measured: one week post-intervention
Empathy Quotient
The EQ is a 60-item survey that assesses ability to relate to others.
Measured: one week post-intervention
Achenbach Adult Behavior Checklist - Self Report
A 126-item survey that asks about behaviors, problems, and substance use.
Measured: one week post-intervention
Social Fluency Assessment
Participants will be filmed in a brief interaction with a typically developing peer. These videos will be analyzed for indicators of social fluency such as eye contact, seconds of silence and number of questions asked.
Measured: one week post-intervention
Achenbach Adult Behavior Checklist
The Achenbach is a 126-item survey that asks about behaviors, problems, and substance use.
Measured: three months post-intervention
Social and Emotional Loneliness Scale for Adults (SELSA)
The SELSA is a 37-item survey that assesses friendships and other relationships.
Measured: three months post-intervention
Social Skills Inventory (SSI)
The SSI is a 90-item survey that measures social competence.
Measured: three months post-intervention
Social Phobia Inventory (SPIN)
The SPIN is a 17-item survey that asks about feelings in social situations.
Measured: three months post-intervention
Empathy Quotient
The EQ is a 60-item survey that assesses ability to relate to others.
Measured: three months post-intervention
Achenbach Adult Behavior Checklist - Self Report
A 126-item survey that asks about behaviors, problems, and substance use.
Measured: three months post-intervention
Social Fluency Assessment
Participants will be filmed in a brief interaction with a typically developing peer. These videos will be analyzed for indicators of social fluency such as eye contact, seconds of silence and number of questions asked.
Measured: three months post-intervention
Social Responsiveness Scale - Adult
The Social Responsiveness Scale - Adult is used to measure levels of social awareness, cognition, communication, motivation, and autistic mannerisms in adults.
Measured: three months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2016 (estimated)
- Study startJul 2013
- Primary completion9 Apr 2018
- Study completion9 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisordersStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pennsylvania Bureau of Autism Services
- Responsible party
- Principal investigator, Michael Murray, Milton S. Hershey Medical Center
- Investigators
- Michael Murray, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02995564
- Sponsor's protocol ID
- 41078EP
- Status last verified
- Mar 2019
- First submitted
- 14 Dec 2016
- Last updated
- 13 Mar 2019
- 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 13 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-Media Social Skills Project for Adults: Validation of an Intervention for Adults With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02995564
- Acronym / sponsor ID
- 41078EP
- Conditions
- Autism Spectrum Disorders
- Keywords
- Social Skills, Asperger's, High-functioning autism, Young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Pennsylvania Bureau of Autism Services
- Study start
- Jul 2013
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 16 Dec 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 is investigating the development of a social skills training program for adults with Asperger's Syndrome or high-functioning autism, ages 18 to 35 years. The Principal Investigator for this study is Dr. Michael Murray, the director of the Autism Studies Division at the Penn State Hershey Medical Center. The purpose of this study is to adapt a social skills training program to address and enhance the social skills of adults with Asperger's Syndrome and high-functioning autism.
Detailed description
During group study visits, a group of six young adults with Asperger's Syndrome or high-functioning autism will meet weekly for about 90 minutes. The purpose of the group sessions is to work on everyday social skills such as initiating and maintaining conversations, establishing friendships, and dealing with situations such as job interviews and dating.
A generalization session will be held every week after the group therapy session with same-age peers who have been screened to participate in the study. The purpose of including peers in the class is to give young adults with Asperger's syndrome and high-functioning autism a chance to practice the social skills learned in the group study visit with a peer group. Study participants will be paired with a typically developing peer for an outing in the community to a nearby restaurant or shop or an in-class exercise such as a mock job interview.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Social Skills Intervention | Experimental | Behavioral: social skills therapyThe intervention is a 16-week social skills therapy program that will consist of a 90 minute group therapy session followed by a 90 minute peer generalization session meeting once per week. Each cohort will consist of 6 adolescents with Aspergers or high-functioning autism, who will be joined by 6 typically-developing peers for the peer generalization portion. During the group therapy session young adults will discuss and watch video clips addressing social skills topics relevant to their age group. They will have a chance to practice these skills when paired with typically developing peer volunteers. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Between 18 and 35 years of age
- Must be a Pennsylvania resident
- A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the SRS-2
- A verbal IQ of 85 or above on the Kaufman Brief Intelligence Test, Second Edition
- English as primary language spoken
Key exclusion criteria (6 listed)
- A significant language delay
- Difficulty with aggression directed at peers
- A primary thought disorder
- A secondary disorder of anxiety or depression so severe as to prevent the individual's participation in the treatment
- A current high school student at start of intervention
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 |
|---|---|---|
| social skills therapySixteen week manual based social skills curriculum targeting social fluency and responsiveness. | Behavioural | Social Skills Intervention |
Primary outcome
Social Responsiveness Scale - Adult
Time frame: One week post-intervention
The Social Responsiveness Scale - Adult is used to measure levels of social awareness, cognition, communication, motivation, and autistic mannerisms in adults.
Video recording of Social Interaction
Time frame: One week post-intervention
Participants will be filmed in a brief interaction with a typically developing peer which will be coded to obtain social interaction skills and fluency scores.
15 secondary outcomes
Achenbach Adult Behavior Checklist
Time frame: One week post-intervention
Social and Emotional Loneliness Scale for Adults (SELSA)
Time frame: one week post-intervention
Social Skills Inventory (SSI)
Time frame: one week post-intervention
Social Phobia Inventory (SPIN)
Time frame: one week post-intervention
Empathy Quotient
Time frame: one week post-intervention
Achenbach Adult Behavior Checklist - Self Report
Time frame: one week post-intervention
Social Fluency Assessment
Time frame: one week post-intervention
Achenbach Adult Behavior Checklist
Time frame: three months post-intervention
Social and Emotional Loneliness Scale for Adults (SELSA)
Time frame: three months post-intervention
Social Skills Inventory (SSI)
Time frame: three months post-intervention
Social Phobia Inventory (SPIN)
Time frame: three months post-intervention
Empathy Quotient
Time frame: three months post-intervention
Achenbach Adult Behavior Checklist - Self Report
Time frame: three months post-intervention
Social Fluency Assessment
Time frame: three months post-intervention
Social Responsiveness Scale - Adult
Time frame: three months post-intervention
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 13 Mar 2019.
- 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.
Michael Murray, MD principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing social skills therapy in people with Autism Spectrum Disorders, run by Milton S. Hershey Medical Center 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 6 inclusion and 6 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 13 Mar 2019. 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?
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?
Social Responsiveness Scale - Adult (time frame: One week post-intervention). 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 13 Mar 2019.