Pervasive Developmental DisordersSSD_ASDNCT02147236
Social Skills in Children With Autism Spectrum Disorders
A study testing Social Skills Training in people with Pervasive Developmental Disorders, run by Yale University at 1 site in United States.
Trial summary
To evaluate whether a structured social skills program, called Social Skills Development,is superior to a wait list control group on measures of interpersonal interaction. The Social Skills Development (SSD) is a 16-week, group intervention that uses activities and peer tutors to promote interpersonal skills in… Read more about this study
- Who is it for?
- Ages 8 to 11 years
- Conditions the study is for
- Pervasive Developmental Disorders
- What is being tested?
- Social Skills Training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2003to Jan 2005
- 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 8 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 8 to 11 years
- Full Scale IQ score > 70
- PDD diagnosis (autism, Asperger's, PDD-Not Otherwise Specified)
Who cannot join
- concurrent, untreated psychiatric disorder(such as anxiety, depression or conduct disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center
New Haven, Connecticut, 06520
About this study
Official title: A Randomized Trial of a Structured Social Skills Development Progam for Children With Autism Spectrum Disorders
To evaluate whether a structured social skills program, called Social Skills Development,is superior to a wait list control group on measures of interpersonal interaction. The Social Skills Development (SSD) is a 16-week, group intervention that uses activities and peer tutors to promote interpersonal skills in children 8 to 11 years of age with Autism Spectrum Disorders.Following a diagnostic and social skills assessment,children are randomly assigned to SSD or wait list for 16 weeks. Children who were randomized to the wait list are offered SSD at Week 16. Children randomized to SSD are followed for 9 months to assess the durability of gains during the first 16 weeks.
Read the detailed description
This project is designed to evaluate the acceptability and initial efficacy of a structured group treatment intervention for enhancing social behavior in 40 children with autism spectrum disorders (ASDs). An important long-term goal of this project was to develop a model for delivery of social skills training that could be tested in a larger trial and ultimately exported to schools and community settings. To accomplish these aims, we designed a randomized clinical trial to evaluate a structured social skills program for school age children with pervasive developmental disorders (PDDs)compared to a Wait List control group. Specific aims included gathering preliminary evidence on the efficacy of the intervention on various parent measures of behavior, as well as an assessment of overall social functioning by an independent rater who would be blind to treatment assignment. The Social Skills Development program uses semi-structured activities and peer tutors to promote interpersanal skills. To evaluate acceptability of the program, we planned to track attendance, attrition and parent satisfaction in the trial. Finally, to evaluate the durability of gains achieved during the Social Skills Development program, we re-assessed the subjects initially randomized to the active treatment group at 9 months post-treatment.
- Conditions
- Pervasive Developmental Disorders
- Being tested
- Social Skills Training
- Keywords
- autism, pervasive developmental disorders, social skills intervention
- Medical subject headings
- Child Development Disorders, Pervasive, Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Social Skills TrainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression for Improvement
Measured: 16 weeks
Secondary outcomes (1)
Social Competence Inventory
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJul 2003
- Primary completionJan 2005
- Study completionJan 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pervasive Developmental DisordersStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Organization of Autism Research, Renfield Foundation
- Responsible party
- Sponsor
- Investigators
- Lawrence D Scahill, MSN,PhD, Principal investigator, Yale University Child Study Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147236
- Sponsor's protocol ID
- 0402026356
- Acronym
- SSD_ASD
- Status last verified
- May 2014
- First submitted
- 21 May 2014
- Last updated
- 26 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial of a Structured Social Skills Development Progam for Children With Autism Spectrum Disorders
- ClinicalTrials.gov ID
- NCT02147236
- Acronym / sponsor ID
- SSD_ASD / 0402026356
- Conditions
- Pervasive Developmental Disorders
- Keywords
- autism, pervasive developmental disorders, social skills intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Organization of Autism Research, Renfield Foundation
- Study start
- Jul 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jan 2005 (actual)
- First posted
- 26 May 2014 (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.
To evaluate whether a structured social skills program, called Social Skills Development,is superior to a wait list control group on measures of interpersonal interaction. The Social Skills Development (SSD) is a 16-week, group intervention that uses activities and peer tutors to promote interpersonal skills in children 8 to 11 years of age with Autism Spectrum Disorders.Following a diagnostic and social skills assessment,children are randomly assigned to SSD or wait list for 16 weeks. Children who were randomized to the wait list are offered SSD at Week 16. Children randomized to SSD are followed for 9 months to assess the durability of gains during the first 16 weeks.
Detailed description
This project is designed to evaluate the acceptability and initial efficacy of a structured group treatment intervention for enhancing social behavior in 40 children with autism spectrum disorders (ASDs). An important long-term goal of this project was to develop a model for delivery of social skills training that could be tested in a larger trial and ultimately exported to schools and community settings. To accomplish these aims, we designed a randomized clinical trial to evaluate a structured social skills program for school age children with pervasive developmental disorders (PDDs)compared to a Wait List control group. Specific aims included gathering preliminary evidence on the efficacy of the intervention on various parent measures of behavior, as well as an assessment of overall social functioning by an independent rater who would be blind to treatment assignment. The Social Skills Development program uses semi-structured activities and peer tutors to promote interpersanal skills. To evaluate acceptability of the program, we planned to track attendance, attrition and parent satisfaction in the trial. Finally, to evaluate the durability of gains achieved during the Social Skills Development program, we re-assessed the subjects initially randomized to the active treatment group at 9 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 8 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 8 to 11 years
- Full Scale IQ score > 70
- PDD diagnosis (autism, Asperger's, PDD-Not Otherwise Specified)
Key exclusion criteria (1 listed)
- concurrent, untreated psychiatric disorder(such as anxiety, depression or conduct 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 |
|---|---|---|
| Social Skills Training | Behavioural | – |
Primary outcome
Clinical Global Impression for Improvement
Time frame: 16 weeks
1 secondary outcome
Social Competence Inventory
Time frame: 16 weeks
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 26 May 2014.
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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.
Lawrence D Scahill, MSN,PhD principal investigator
Yale University Child Study 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 Social Skills Training in people with Pervasive Developmental Disorders, run by Yale 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: finished, as of the sponsor's last update on 26 May 2014. 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?
Clinical Global Impression for Improvement (time frame: 16 weeks). 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 26 May 2014.