Asperger's DisorderASSTNCT01031823
Adolescent Social Skills Training Program
A study testing Multi-Media Social Skills Training Program in people with Asperger's Disorder and High-functioning Autism, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study is a pre-test, post-test single group design with follow-up at month three. Twenty-four individuals total will participate in this study with 6 participants in each of 4 cohorts. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Asperger's Disorder, High-functioning Autism
- What is being tested?
- Multi-Media Social Skills Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2009to 10 Jul 2013
- 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 13 and 17 years of age
- A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Autism Disorders Interview-Revised (ADIR; Rutter \& LeCourteur, 1995)
- An IQ of 70 or above on the Kaufman Brief Intelligence Test, Second Edition (KBIT-2; Kaufman \& Kaufman, 1990)
- Local to Central Pennsylvania region
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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: The Multi-media Social Skills Project: Validation of an Intervention for Adolescents With Autism Spectrum Disorders
This study is a pre-test, post-test single group design with follow-up at month three. Twenty-four individuals total will participate in this study with 6 participants in each of 4 cohorts. Participants and their parents will complete pre-test measures including both paper and pencil measures and a video-recording to assess the participant's social interaction skills and fluency. These adolescents will participate in both group therapy and peer generalization sessions once a week over the course of twelve weeks. Upon completion of the intervention, participants and parents will complete paper and pencil and video post-test measures. Participants will be encouraged to participate in one follow-up session where the paper and pencil and video measures will be completed again.
Read the detailed description
After consent , has been obtained, parents will complete the Autism Disorders Interview-Revised (ADI-R; Rutter \& LeCourteur, 1995) to determine eligibility and the Checklist for Autism Spectrum Disorder (Mayes \& Calhoun, 1999), the Social Responsiveness Scale (SRS; Constantino, 2002), and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) at the initial appointment with the study coordinator.
After assent has been obtained, adolescents will complete the Kaufman Brief Intelligence Test, Second Edition (KBIT-2; Kaufman \& Kaufman, 1990) to determine eligibility and the Checklist for Autism Spectrum Disorder (Mayes \& Calhoun, 1999), the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) and the Loneliness Scale (Asher \& Wheeler, 1985). Adolescents will also complete a standardized joint attention assessment.
After the completion of the eligibility and pre-test interventions there will be a wash of participants who do not meet eligibility requirements.
One week before the start of the program, participants will attend an introduction session to the program. At this time, participants will be filmed in a brief interaction with a typically developing peer that will be used as a baseline indicator of their social fluency.
Participants will attend the social skills intervention program once a week for twelve weeks. Each week there will be approximately 90 minutes of group therapy which will be conducted like a seminar class: the principal investigator will teach and review social interaction skills and nuances, participants will be encouraged to take an active role in the class.
During the twelve week intervention there will be three review/fluency building sessions: week four, week eight, and week twelve. The group therapy sessions for these review weeks will simply review the material that was covered during the prior three weeks. Participants will then practice what they have learned by having a conversation with a peer that will be taped.
Following the group therapy session each week, participants will join six typically developing peers in a 90 minute introductory photography class taught by one of the study's co-investigators. The photography class will give the participants the opportunity to practice the skills learned in group therapy with their peer group.
Participants will once again complete a battery of clinical and self-report outcome measures which will serve as the post-test measurements for the study. They will be filmed in a brief interaction with a typically developing peer which will be coded to obtain post-test social interaction skills and fluency scores. These evaluations will occur at completion of social skills program, and at three month follow-up.
- Conditions
- Asperger's Disorder, High-functioning Autism
- Being tested
- Multi-Media Social Skills Training Program
- Keywords
- Autism Spectrum Disorder
- Medical subject headings
- Asperger Syndrome, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-Media Social Skills Training ProgramBehavioural
All individuals will participate in a twelve week social skills training program designed to enhance the social skills of adolescents with Asperger's Disorder or high-functioning autism. The intervention is comprised of both group therapy and peer generalization.
| Study group | Role | What they receive |
|---|---|---|
| Social Skills Training | Experimental | All participants will take part in this arm of the study. Receives: Behavioral: Multi-Media Social Skills Training Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Fluency
Measured: 12 week, 3 month
Secondary outcomes (3)
Loneliness Scale (Asher & Wheeler, 1985)
Measured: 12 week, 3 month
Social Responsiveness Scale (SRS; Constantino, 2002)
Measured: 12 week, 3 month
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Measured: 12 week, 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionOct 2012
- Study completion10 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asperger's 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Murray, Milton S. Hershey Medical Center
- Investigators
- Micheal J Murray, M.D., Principal investigator, Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01031823
- Sponsor's protocol ID
- 32300
- Acronym
- ASST
- Status last verified
- Jun 2019
- First submitted
- 12 Dec 2009
- Last updated
- 6 Jun 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Multi-media Social Skills Project: Validation of an Intervention for Adolescents With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01031823
- Acronym / sponsor ID
- ASST / 32300
- Conditions
- Asperger's Disorder, High-functioning Autism
- Keywords
- Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Nov 2009 (actual)
- Primary completion
- Oct 2012 (actual)
- Study completion
- 10 Jul 2013 (actual)
- First posted
- 15 Dec 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.
This study is a pre-test, post-test single group design with follow-up at month three. Twenty-four individuals total will participate in this study with 6 participants in each of 4 cohorts. Participants and their parents will complete pre-test measures including both paper and pencil measures and a video-recording to assess the participant's social interaction skills and fluency. These adolescents will participate in both group therapy and peer generalization sessions once a week over the course of twelve weeks. Upon completion of the intervention, participants and parents will complete paper and pencil and video post-test measures. Participants will be encouraged to participate in one follow-up session where the paper and pencil and video measures will be completed again.
Detailed description
After consent , has been obtained, parents will complete the Autism Disorders Interview-Revised (ADI-R; Rutter \& LeCourteur, 1995) to determine eligibility and the Checklist for Autism Spectrum Disorder (Mayes \& Calhoun, 1999), the Social Responsiveness Scale (SRS; Constantino, 2002), and the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) at the initial appointment with the study coordinator.
After assent has been obtained, adolescents will complete the Kaufman Brief Intelligence Test, Second Edition (KBIT-2; Kaufman \& Kaufman, 1990) to determine eligibility and the Checklist for Autism Spectrum Disorder (Mayes \& Calhoun, 1999), the Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997) and the Loneliness Scale (Asher \& Wheeler, 1985). Adolescents will also complete a standardized joint attention assessment.
After the completion of the eligibility and pre-test interventions there will be a wash of participants who do not meet eligibility requirements.
One week before the start of the program, participants will attend an introduction session to the program. At this time, participants will be filmed in a brief interaction with a typically developing peer that will be used as a baseline indicator of their social fluency.
Participants will attend the social skills intervention program once a week for twelve weeks. Each week there will be approximately 90 minutes of group therapy which will be conducted like a seminar class: the principal investigator will teach and review social interaction skills and nuances, participants will be encouraged to take an active role in the class.
During the twelve week intervention there will be three review/fluency building sessions: week four, week eight, and week twelve. The group therapy sessions for these review weeks will simply review the material that was covered during the prior three weeks. Participants will then practice what they have learned by having a conversation with a peer that will be taped.
Following the group therapy session each week, participants will join six typically developing peers in a 90 minute introductory photography class taught by one of the study's co-investigators. The photography class will give the participants the opportunity to practice the skills learned in group therapy with their peer group.
Participants will once again complete a battery of clinical and self-report outcome measures which will serve as the post-test measurements for the study. They will be filmed in a brief interaction with a typically developing peer which will be coded to obtain post-test social interaction skills and fluency scores. These evaluations will occur at completion of social skills program, and at three month follow-up.
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 Training | Experimental | Behavioral: Multi-Media Social Skills Training ProgramAll participants will take part in this arm of the study. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Between 13 and 17 years of age
- A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Autism Disorders Interview-Revised (ADIR; Rutter \& LeCourteur, 1995)
- An IQ of 70 or above on the Kaufman Brief Intelligence Test, Second Edition (KBIT-2; Kaufman \& Kaufman, 1990)
- Local to Central Pennsylvania region
Key exclusion criteria (4 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
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 |
|---|---|---|
| Multi-Media Social Skills Training ProgramAll individuals will participate in a twelve week social skills training program designed to enhance the social skills of adolescents with Asperger's Disorder or high-functioning autism. The intervention is comprised of both group therapy and peer generalization. | Behavioural | Social Skills Training |
Primary outcome
Social Fluency
Time frame: 12 week, 3 month
3 secondary outcomes
Loneliness Scale (Asher & Wheeler, 1985)
Time frame: 12 week, 3 month
Social Responsiveness Scale (SRS; Constantino, 2002)
Time frame: 12 week, 3 month
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Time frame: 12 week, 3 month
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 6 Jun 2019.
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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.
Micheal J Murray, M.D. principal investigator
Penn State College of Medicine, Penn State Milton S. Hershey Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-Media Social Skills Training Program in people with Asperger's Disorder and High-functioning Autism, 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 4 inclusion and 4 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 6 Jun 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 Fluency (time frame: 12 week, 3 month). 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 6 Jun 2019.