Autism Spectrum DisorderNCT02439671
Transition Support Program for Young Adults With Autism Spectrum Disorders
A study testing McGill Transition Support Program in people with Autism Spectrum Disorder, run by McGill University at 1 site in Canada.
Trial summary
This study investigates a service delivery model to better support young adults with autism spectrum disorders (ASD) in the transition from school to the community. The effectiveness of the "McGill Transition Support Program", a small-group format intervention (meeting once a week for 2 hours over 10 weeks) focusing… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- McGill Transition Support Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- May 2012to Jul 2016
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- proficient and able to communicate in English
- between the ages of 18 and 30 years upon entering the study
- ASD classification according to scores on either or both the Social Communication Questionnaire-Lifetime (SCQ) and the Autism Diagnostic Observation Schedule-2 (ADOS-2, Module 4 revised algorithm)
- Either or both non-verbal IQ, assessed by Raven's Progressive Matrices, or verbal IQ assessed by Wechsler Abbreviated Scales of Intelligence, verbal subtests, in the normal range
Who cannot join
- current enrollment in another similar transition support service, that is, a group-format service that has the goals of improving the areas of social interaction and communication, self-determination and advocacy, and working with others skills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Service Delivery Model to Better Support Young Adults With Autism Spectrum Disorders in the Transition From School to the Community
This study investigates a service delivery model to better support young adults with autism spectrum disorders (ASD) in the transition from school to the community. The effectiveness of the "McGill Transition Support Program", a small-group format intervention (meeting once a week for 2 hours over 10 weeks) focusing on communication, self-determination and working with others skills, is measured by multiple pre- and post-program-assessments in a "staggered enrollment trial", a variant of a randomized controlled trial (RCT).
Read the detailed description
The difficulties characterizing Autism Spectrum Disorder (ASD) are often associated with childhood; however, ASD is a lifespan diagnosis that continues to impact opportunities in the community. There is currently a very significant gap in support services for young adults with ASDs that has grave consequences both for individuals and their families in terms of vocational success and social inclusion and for society as a whole in terms of the financial burden of long-term adult care.
Individuals on the higher end of the autism spectrum do not have intellectual disability and possess good language skills. Yet they often show significant difficulty with applying their skills during demanding social interactions, which is detrimental to their ability to form relationships and navigate interactions in the workplace. In the few studies of outcomes of adults with ASD it is reported that fewer than 5% of adults at the highest end of the spectrum were living independently and only 12% were employed viably. This underscores the tremendous need for targeted services for young adults with ASD without intellectual disability.
The McGill Transition Support Program was developed to target participants' self-expressed needs in communication, self-determination and working with others skills, which have been associated with better quality of life. Besides the intake, pre- and post-program measures sessions, the participants, aged 18 - 30 years, take part in ten 2-hour group meetings. The study design has been termed a "staggered enrollment trial", that is participants were randomly assigned to take part in the program in the next available cycle or to the waiting list for a subsequent cycle. Pre- and post-program assessment include social problem solving stories, quality of life and self-determination measures, a communication task and a needs and skills questionnaire.
- Conditions
- Autism Spectrum Disorder
- Being tested
- McGill Transition Support Program
- Keywords
- Transition Support Program for young adults
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
McGill Transition Support ProgramBehavioural
The McGill Transition Support Program is manual-based, including 15 modules of curriculum, five in each of the following domains of skills:
- Social communication (e.g. listening, perspective taking)
- Self-determination (e.g. problem-solving, self-advocacy)
- Working with others (e.g. knowing your context, teamwork)
Nine out of the 15 modules are selected for each group according to the common needs endorsed by participants on a needs assessment questionnaire. Each group consists of 4 adults and two facilitators who were graduate students in Speech Language Pathology or Educational Psychology.
The intervention follows a Self-Determination Learning Model of Instruction (SDLMI) that considers the individual's strengths and needs in the development of personal goals and plans for one's future. A workbook is used to accompany each module with the aim of having the participants practice and generalize the main content messages.
| Study group | Role | What they receive |
|---|---|---|
| Immediate intervention | Experimental | Participant assigned to McGill Transition Support Program in next available session Receives: Behavioral: McGill Transition Support Program |
| Waiting List control | No intervention | Participant assigned to waiting list for one session prior to receiving McGill Transition Support Program in following session |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Social problem-solving task (Channon & Crawford, 2010)
Measured: 4-6 weeks prior to session, 4-6 weeks after session
Change in Arc's Self-Determination Scale (SDS; Wehmeyer & Kelchner, 1995)
Measured: 4-6 weeks prior to session, 4-6 weeks after session, and 12 month follow-up post-Program
Change in Quality of Life Questionnaire (Shalock & Keith, 1993)
Measured: 4-6 weeks prior to session, abridged version: 4-6 weeks after session and 12 month follow-up post-Program
Secondary outcomes (5)
Curriculum-specific workbook questions
Measured: every week for 9 weeks at the end of group intervention meetings
Participant Program Evaluation Survey (Flanagan & Nadig, 2012)
Questionnaire composed of qualitative (open-ended) questions
Measured: 4-6 weeks after Program and 12 month follow-up post-Program
Parent Program Evaluation Survey (Flanagan & Nadig, 2012)
(Questionnaire composed of quantitative (Likert-type) and qualitative (open-ended) questions)
Measured: 4-6 weeks after Program
Questionnaire on vocational, educational and living situation outcomes
Measured: 12 month follow-up post-Program
Communication task (Nadig, Vivanti, & Ozonoff, 2009)
Measured: 4-6 weeks prior to session, 4-6 weeks after session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startMay 2012
- Primary completionJul 2015
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aparna Nadig, McGill University
- Investigators
- Aparna Nadig, Ph.D., Principal investigator, School of Communication Sciences and Disorders, McGill UniversityTara Flanagan, Ph.D., Principal investigator, Department of Educational and Counselling Psychology, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02439671
- Sponsor's protocol ID
- Max Bell / McGill x-209094
- Status last verified
- May 2017
- First submitted
- 4 May 2015
- Last updated
- 9 May 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Channon S, Crawford S. Mentalising and social problem-solving after brain injury. Neuropsychol Rehabil. 2010 Oct;20(5):739-59. doi: 10.1080/09602011003794583. Epub 2010 Jun 1.
PubMed 20526955Ganz ML. The lifetime distribution of the incremental societal costs of autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):343-9. doi: 10.1001/archpedi.161.4.343.
PubMed 17404130Mercer SL, DeVinney BJ, Fine LJ, Green LW, Dougherty D. Study designs for effectiveness and translation research :identifying trade-offs. Am J Prev Med. 2007 Aug;33(2):139-154. doi: 10.1016/j.amepre.2007.04.005.
PubMed 17673103Nadig A, Vivanti G, Ozonoff S. Adaptation of object descriptions to a partner under increasing communicative demands: a comparison of children with and without autism. Autism Res. 2009 Dec;2(6):334-47. doi: 10.1002/aur.102.
PubMed 19998354Taylor JL, Seltzer MM. Changes in the autism behavioral phenotype during the transition to adulthood. J Autism Dev Disord. 2010 Dec;40(12):1431-46. doi: 10.1007/s10803-010-1005-z.
PubMed 20361245Howlin P, Goode S, Hutton J, Rutter M. Adult outcome for children with autism. J Child Psychol Psychiatry. 2004 Feb;45(2):212-29. doi: 10.1111/j.1469-7610.2004.00215.x.
PubMed 14982237Barnard J, Harvey V, Potter D, Prior A. Ignored or ineligible? The reality for adults with autism spectrum disorders. The National Autistic Society report for Autism Awareness Week. 2001. London: NAS publications.
Flangan T, Nadig A. Transition Support Needs Assessment. 2012
Graetz JE. Autism grows up: opportunities for adults with autism. Disability and Society. 2010;25(1):33-47.
Hendricks DR, Wehman P. Transition from school to adulthood for youth with autism spectrum disorders. Focus on Autism and Other Developmental Disabilities. 2009;24(2):77-88.
Levy A, Perry A. Outcomes in adolescents and adults with autism: A review of the literature. Research in Autism Spectrum Disorders. 2011;5(4):1271-1282.
Lord C, Rutter M, DiLavore PC, Risi S. Autism Diagnostic Observation Schedule (ADOS). 1999. Los Angeles, CA: Western Psychological Association.
Raven J, Raven JC, Court JH. Manual for Raven's Progressive Matrices and Vocabulary Scales. 2003, updated 2004. San Antonio, TX: Pearson Assessment.
Rutter M, Bailey A, Berument SK, Lord C, Pickles A. Social Communication Questionnaire (SCQ). 2003. Los Angeles, CA: Western Psychological Services.
Schalock R, Keith K. Quality of Life Questionnaire. 1993, 2004 Revision. Worthington, OH: IDS Publishing.
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Service Delivery Model to Better Support Young Adults With Autism Spectrum Disorders in the Transition From School to the Community
- ClinicalTrials.gov ID
- NCT02439671
- Acronym / sponsor ID
- Max Bell / McGill x-209094
- Conditions
- Autism Spectrum Disorder
- Keywords
- Transition Support Program for young adults
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- McGill UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 12 May 2015 (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 investigates a service delivery model to better support young adults with autism spectrum disorders (ASD) in the transition from school to the community. The effectiveness of the "McGill Transition Support Program", a small-group format intervention (meeting once a week for 2 hours over 10 weeks) focusing on communication, self-determination and working with others skills, is measured by multiple pre- and post-program-assessments in a "staggered enrollment trial", a variant of a randomized controlled trial (RCT).
Detailed description
The difficulties characterizing Autism Spectrum Disorder (ASD) are often associated with childhood; however, ASD is a lifespan diagnosis that continues to impact opportunities in the community. There is currently a very significant gap in support services for young adults with ASDs that has grave consequences both for individuals and their families in terms of vocational success and social inclusion and for society as a whole in terms of the financial burden of long-term adult care.
Individuals on the higher end of the autism spectrum do not have intellectual disability and possess good language skills. Yet they often show significant difficulty with applying their skills during demanding social interactions, which is detrimental to their ability to form relationships and navigate interactions in the workplace. In the few studies of outcomes of adults with ASD it is reported that fewer than 5% of adults at the highest end of the spectrum were living independently and only 12% were employed viably. This underscores the tremendous need for targeted services for young adults with ASD without intellectual disability.
The McGill Transition Support Program was developed to target participants' self-expressed needs in communication, self-determination and working with others skills, which have been associated with better quality of life. Besides the intake, pre- and post-program measures sessions, the participants, aged 18 - 30 years, take part in ten 2-hour group meetings. The study design has been termed a "staggered enrollment trial", that is participants were randomly assigned to take part in the program in the next available cycle or to the waiting list for a subsequent cycle. Pre- and post-program assessment include social problem solving stories, quality of life and self-determination measures, a communication task and a needs and skills questionnaire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Immediate intervention | Experimental | Behavioral: McGill Transition Support ProgramParticipant assigned to McGill Transition Support Program in next available session |
| Waiting List control | No intervention | –Participant assigned to waiting list for one session prior to receiving McGill Transition Support Program in following session |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- proficient and able to communicate in English
- between the ages of 18 and 30 years upon entering the study
- ASD classification according to scores on either or both the Social Communication Questionnaire-Lifetime (SCQ) and the Autism Diagnostic Observation Schedule-2 (ADOS-2, Module 4 revised algorithm)
- Either or both non-verbal IQ, assessed by Raven's Progressive Matrices, or verbal IQ assessed by Wechsler Abbreviated Scales of Intelligence, verbal subtests, in the normal range
Key exclusion criteria (1 listed)
- current enrollment in another similar transition support service, that is, a group-format service that has the goals of improving the areas of social interaction and communication, self-determination and advocacy, and working with others skills
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 |
|---|---|---|
| McGill Transition Support ProgramThe McGill Transition Support Program is manual-based, including 15 modules of curriculum, five in each of the following domains of skills: * Social communication (e.g. listening, perspective taking) * Self-determination (e.g. problem-solving, self-advocacy) * Working with others (e.g. knowing your context, teamwork) Nine out of the 15 modules are selected for each group according to the common needs endorsed by participants on a needs assessment questionnaire. Each group consists of 4 adults and two facilitators who were graduate students in Speech Language Pathology or Educational Psychology. The intervention follows a Self-Determination Learning Model of Instruction (SDLMI) that considers the individual's strengths and needs in the development of personal goals and plans for one's future. A workbook is used to accompany each module with the aim of having the participants practice and generalize the main content messages. | Behavioural | Immediate intervention |
Primary outcome
Change in Social problem-solving task (Channon & Crawford, 2010)
Time frame: 4-6 weeks prior to session, 4-6 weeks after session
Change in Arc's Self-Determination Scale (SDS; Wehmeyer & Kelchner, 1995)
Time frame: 4-6 weeks prior to session, 4-6 weeks after session, and 12 month follow-up post-Program
Change in Quality of Life Questionnaire (Shalock & Keith, 1993)
Time frame: 4-6 weeks prior to session, abridged version: 4-6 weeks after session and 12 month follow-up post-Program
5 secondary outcomes
Curriculum-specific workbook questions
Time frame: every week for 9 weeks at the end of group intervention meetings
Participant Program Evaluation Survey (Flanagan & Nadig, 2012)
Time frame: 4-6 weeks after Program and 12 month follow-up post-Program
Parent Program Evaluation Survey (Flanagan & Nadig, 2012)
Time frame: 4-6 weeks after Program
Questionnaire on vocational, educational and living situation outcomes
Time frame: 12 month follow-up post-Program
Communication task (Nadig, Vivanti, & Ozonoff, 2009)
Time frame: 4-6 weeks prior to session, 4-6 weeks after session
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 9 May 2017.
- Background: PubMed 20526955Channon S, Crawford S. Mentalising and social problem-solving after brain injury. Neuropsychol Rehabil. 2010 Oct;20(5):739-59. doi: 10.1080/09602011003794583. Epub 2010 Jun 1.
- Background: PubMed 17404130Ganz ML. The lifetime distribution of the incremental societal costs of autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):343-9. doi: 10.1001/archpedi.161.4.343.
- Background: PubMed 17673103Mercer SL, DeVinney BJ, Fine LJ, Green LW, Dougherty D. Study designs for effectiveness and translation research :identifying trade-offs. Am J Prev Med. 2007 Aug;33(2):139-154. doi: 10.1016/j.amepre.2007.04.005.
- Background: PubMed 19998354Nadig A, Vivanti G, Ozonoff S. Adaptation of object descriptions to a partner under increasing communicative demands: a comparison of children with and without autism. Autism Res. 2009 Dec;2(6):334-47. doi: 10.1002/aur.102.
- Background: PubMed 20361245Taylor JL, Seltzer MM. Changes in the autism behavioral phenotype during the transition to adulthood. J Autism Dev Disord. 2010 Dec;40(12):1431-46. doi: 10.1007/s10803-010-1005-z.
- Background: PubMed 14982237Howlin P, Goode S, Hutton J, Rutter M. Adult outcome for children with autism. J Child Psychol Psychiatry. 2004 Feb;45(2):212-29. doi: 10.1111/j.1469-7610.2004.00215.x.
- BackgroundBarnard J, Harvey V, Potter D, Prior A. Ignored or ineligible? The reality for adults with autism spectrum disorders. The National Autistic Society report for Autism Awareness Week. 2001. London: NAS publications.
- BackgroundFlangan T, Nadig A. Transition Support Needs Assessment. 2012
- BackgroundGraetz JE. Autism grows up: opportunities for adults with autism. Disability and Society. 2010;25(1):33-47.
- BackgroundHendricks DR, Wehman P. Transition from school to adulthood for youth with autism spectrum disorders. Focus on Autism and Other Developmental Disabilities. 2009;24(2):77-88.
- BackgroundLevy A, Perry A. Outcomes in adolescents and adults with autism: A review of the literature. Research in Autism Spectrum Disorders. 2011;5(4):1271-1282.
- BackgroundLord C, Rutter M, DiLavore PC, Risi S. Autism Diagnostic Observation Schedule (ADOS). 1999. Los Angeles, CA: Western Psychological Association.
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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.
Aparna Nadig, Ph.D. principal investigator
School of Communication Sciences and Disorders, McGill University
Tara Flanagan, Ph.D. principal investigator
Department of Educational and Counselling Psychology, McGill 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 McGill Transition Support Program in people with Autism Spectrum Disorder, run by McGill University at 1 site in Canada.
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 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 9 May 2017. 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 Canada. 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 in Social problem-solving task (Channon & Crawford, 2010) (time frame: 4-6 weeks prior to session, 4-6 weeks after session). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02439671, which also lists 20 linked publications.
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 9 May 2017; AzTrials last refreshed its copy on 29 Oct 2026.