- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02439671
Transition Support Program for Young Adults With Autism Spectrum Disorders
A Service Delivery Model to Better Support Young Adults With Autism Spectrum Disorders in the Transition From School to the Community
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montreal, Quebec, Canada
- McGill University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Immediate intervention
Participant assigned to McGill Transition Support Program in next available session
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The McGill Transition Support Program is manual-based, including 15 modules of curriculum, five in each of the following domains of skills:
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. |
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No Intervention: Waiting List control
Participant assigned to waiting list for one session prior to receiving McGill Transition Support Program in following session
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Change in Social problem-solving task (Channon & Crawford, 2010)
Time Frame: 4-6 weeks prior to session, 4-6 weeks after session
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4-6 weeks prior to session, 4-6 weeks after session
|
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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
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4-6 weeks prior to session, 4-6 weeks after session, and 12 month follow-up post-Program
|
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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
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4-6 weeks prior to session, abridged version: 4-6 weeks after session and 12 month follow-up post-Program
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Curriculum-specific workbook questions
Time Frame: every week for 9 weeks at the end of group intervention meetings
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every week for 9 weeks at the end of group intervention meetings
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|
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Participant Program Evaluation Survey (Flanagan & Nadig, 2012)
Time Frame: 4-6 weeks after Program and 12 month follow-up post-Program
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Questionnaire composed of qualitative (open-ended) questions
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4-6 weeks after Program and 12 month follow-up post-Program
|
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Parent Program Evaluation Survey (Flanagan & Nadig, 2012)
Time Frame: 4-6 weeks after Program
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(Questionnaire composed of quantitative (Likert-type) and qualitative (open-ended) questions)
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4-6 weeks after Program
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Questionnaire on vocational, educational and living situation outcomes
Time Frame: 12 month follow-up post-Program
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12 month follow-up post-Program
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Communication task (Nadig, Vivanti, & Ozonoff, 2009)
Time Frame: 4-6 weeks prior to session, 4-6 weeks after session
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4-6 weeks prior to session, 4-6 weeks after session
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aparna Nadig, Ph.D., School of Communication Sciences and Disorders, McGill University
- Principal Investigator: Tara Flanagan, Ph.D., Department of Educational and Counselling Psychology, McGill University
Publications and helpful links
General 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.
- Ganz 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.
- Mercer 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.
- Nadig 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.
- Taylor 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.
- Howlin 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.
- Barnard 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.
- Wechsler D. Wechsler Abbreviated Scales of Intelligence (WASI). 1999. San Antonio, TX: The Psychological Corporation/Harcourt Assessment.
- Wehmeyer ML, Field S. Self-determination: Instructional and assessment strategies. 2007. Thousand Oaks, CA: Corwin Press.
- Wehmeyer ML. Student self-report measure of self- determination for students with cognitive disabilities. Education and Training in Mental Retardation and Developmental Disabilities. 1996;31:282-293.
- Wehmeyer ML, Kelchner K. The Arc's Self-Determination Scale. 1995. Arlington, TX: Arc National Headquarters.
- Nadig A, Flanagan T, White K, Bhatnagar S. Results of a RCT on a Transition Support Program for Adults with ASD: Effects on Self-Determination and Quality of Life. Autism Res. 2018 Dec;11(12):1712-1728. doi: 10.1002/aur.2027. Epub 2018 Nov 19.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Max Bell / McGill x-209094
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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