Autism Spectrum DisordersNCT01836965
Replication of the The Multi-Media Social Skills Project for Adolescents With Autism Spectrum Disorders
A study testing Social Skills Intervention in people with Autism Spectrum Disorders, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The objective of this study is to validate a social skills training program manual for adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately 150 adolescents with autism spectrum disorders will participate in this study, in groups consisting of 6 adolescents and 6 peer volunteers. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorders
- What is being tested?
- Social Skills Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 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 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Between 13 and 17 years of age
- Must be a Pennsylvania resident
- A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Checklist for Autism Spectrum Disorders (CASD; Mayes, 2012)
- English as primary language spoken
- Ability to fluently speak in full sentences
- A verbal IQ of 85 or above on the Kaufman Brief Intelligence Test, Second Edition(KBIT-2; Kaufman \& Kaufman, 1990)
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
- Low social motivation demonstrated through formalized assessment and/or by responses given to screening interviews assessing treatment goals
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Hershey Psychiatry Clinic
Hershey, Pennsylvania, 17033
About this study
The objective of this study is to validate a social skills training program manual for adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately 150 adolescents with autism spectrum disorders will participate in this study, in groups consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both group therapy and peer generalization sessions (in the form of a photography class) once a week over the course of twelve weeks. Participants and their parents will complete paper and pencil, online, or phone measures and video-recordings to assess the participant's social skills prior to the intervention, at completion of the intervention and three months later.
Read the detailed description
This study is a pre-test, post-test single group design with post test measures at one week after completion of intervention and follow-up at three months. Approximately 300 adolescents will participate in this study. The study will be conducted in ten cohorts of 12. Each cohort will have 6 participants and 6 adolescent volunteers (peers). Cohorts will be run in a time sequential manner with up to four cohorts running at a time. Participants and their parents will complete pre-test measures including both paper and pencil, online, or phone 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, online, or phone measures and video post-test measures. Participants will be encouraged to participate in a follow-up session where the paper and pencil and video measures will be completed again.
- Conditions
- Autism Spectrum Disorders
- Being tested
- Social Skills Intervention
- Keywords
- Aspergers, Social Skills, Adolescents, High-functioning Autism
- 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 InterventionBehavioural
Twelve 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 12-week social skills training program that will consist of a 90 minute group therapy session followed by a 90 minute peer generalization session (in the form of a photography class with typically developing peers) 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 photography class. During the group therapy session adolescents 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 a typically developing peer for the photography class. Receives: Behavioral: Social Skills Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Social Responsiveness Scale Score after Intervention
The Social Responsiveness Scale is a 65 - item survey designed to measure social competence.
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 (8)
Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention
The SDQ is a 25 item survey that asks about positive and negative attributes.
Measured: One Week Post-Intervention
Change from Baseline Loneliness Scale after Intervention
The Loneliness Scale is a 24-item survey that assesses social and emotional loneliness.
Measured: One Week Post Intervention
Change from Baseline Multidimensional Anxiety Scale for Children after Intervention
The MASC is a 39-item survey that assesses anxiety symptoms in children.
Measured: One Week Post-Intervention
Change from Baseline Strengths and Difficulties Questionnaire (parent form)after Intervention
The Strengths and Difficulties Questionnaire is a 25 item survey that asks about positive and negative attributes.
Measured: One Week Post-Intervention
Change from Baseline Strengths and Difficulties Questionnaire at 3 month Follow Up
Measured: 3 Month Follow Up
Change from Baseline Loneliness Scale at 3-month Follow Up
Measured: 3 Month Follow Up
Change from Baseline Multidimensional Anxiety Scale for Children at 3 month Follow Up
Measured: 3 Month Follow Up
Change from Baseline Strengths and Difficulties Questionnaire (parent form)at 3 Month Follow Up
Measured: 3 Month Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startMar 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
- 155 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
- Michael Murray, MD, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836965
- Sponsor's protocol ID
- 42565EP
- Status last verified
- Mar 2019
- First submitted
- 28 Mar 2013
- 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
- Replication of the The Multi-Media Social Skills Project for Adolescents With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT01836965
- Acronym / sponsor ID
- 42565EP
- Conditions
- Autism Spectrum Disorders
- Keywords
- Aspergers, Social Skills, Adolescents, High-functioning Autism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- 9 Apr 2018 (actual)
- Study completion
- 9 Apr 2018 (actual)
- First posted
- 22 Apr 2013 (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 objective of this study is to validate a social skills training program manual for adolescents (ages 13-17) with Asperger's Syndrome or high functioning autism. Approximately 150 adolescents with autism spectrum disorders will participate in this study, in groups consisting of 6 adolescents and 6 peer volunteers. Participants will participate in both group therapy and peer generalization sessions (in the form of a photography class) once a week over the course of twelve weeks. Participants and their parents will complete paper and pencil, online, or phone measures and video-recordings to assess the participant's social skills prior to the intervention, at completion of the intervention and three months later.
Detailed description
This study is a pre-test, post-test single group design with post test measures at one week after completion of intervention and follow-up at three months. Approximately 300 adolescents will participate in this study. The study will be conducted in ten cohorts of 12. Each cohort will have 6 participants and 6 adolescent volunteers (peers). Cohorts will be run in a time sequential manner with up to four cohorts running at a time. Participants and their parents will complete pre-test measures including both paper and pencil, online, or phone 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, online, or phone measures and video post-test measures. Participants will be encouraged to participate in a follow-up session where the paper and pencil and video measures will be completed again.
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 InterventionThe intervention is a 12-week social skills training program that will consist of a 90 minute group therapy session followed by a 90 minute peer generalization session (in the form of a photography class with typically developing peers) 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 photography class. During the group therapy session adolescents 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 a typically developing peer for the photography class. |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Between 13 and 17 years of age
- Must be a Pennsylvania resident
- A primary diagnosis of Asperger's Syndrome or high-functioning autism, as confirmed by the Checklist for Autism Spectrum Disorders (CASD; Mayes, 2012)
- English as primary language spoken
- Ability to fluently speak in full sentences
Key exclusion criteria (5 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
- Low social motivation demonstrated through formalized assessment and/or by responses given to screening interviews assessing treatment goals
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 InterventionTwelve week manual based social skills curriculum targeting social fluency and responsiveness. | Behavioural | Social Skills Intervention |
Primary outcome
Change from Baseline Social Responsiveness Scale Score after Intervention
Time frame: One Week Post-Intervention
The Social Responsiveness Scale is a 65 - item survey designed to measure social competence.
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.
8 secondary outcomes
Change from Baseline Strengths and Difficulties Questionnaire (SDQ) after Intervention
Time frame: One Week Post-Intervention
Change from Baseline Loneliness Scale after Intervention
Time frame: One Week Post Intervention
Change from Baseline Multidimensional Anxiety Scale for Children after Intervention
Time frame: One Week Post-Intervention
Change from Baseline Strengths and Difficulties Questionnaire (parent form)after Intervention
Time frame: One Week Post-Intervention
Change from Baseline Strengths and Difficulties Questionnaire at 3 month Follow Up
Time frame: 3 Month Follow Up
Change from Baseline Loneliness Scale at 3-month Follow Up
Time frame: 3 Month Follow Up
Change from Baseline Multidimensional Anxiety Scale for Children at 3 month Follow Up
Time frame: 3 Month Follow Up
Change from Baseline Strengths and Difficulties Questionnaire (parent form)at 3 Month Follow Up
Time frame: 3 Month Follow Up
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 Intervention 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 5 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?
Change from Baseline Social Responsiveness Scale Score after Intervention (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.