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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02439671
Other study ID # Max Bell / McGill x-209094
Secondary ID
Status Completed
Phase N/A
First received May 4, 2015
Last updated May 8, 2017
Start date May 2012
Est. completion date July 2016

Study information

Verified date May 2017
Source McGill University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date July 2016
Est. primary completion date July 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years to 30 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
McGill Transition Support Program
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.

Locations

Country Name City State
Canada McGill University Montreal Quebec

Sponsors (1)

Lead Sponsor Collaborator
McGill University

Country where clinical trial is conducted

Canada, 

References & Publications (19)

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.

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. — View Citation

Flangan T, Nadig A. Transition Support Needs Assessment. 2012

Ganz ML. The lifetime distribution of the incremental societal costs of autism. Arch Pediatr Adolesc Med. 2007 Apr;161(4):343-9. — View Citation

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.

Howlin P, Goode S, Hutton J, Rutter M. Adult outcome for children with autism. J Child Psychol Psychiatry. 2004 Feb;45(2):212-29. — View Citation

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.

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. — View Citation

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. — View Citation

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.

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. — View Citation

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, Kelchner K. The Arc's Self-Determination Scale. 1995. Arlington, TX: Arc National Headquarters.

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.

* Note: There are 19 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Social problem-solving task (Channon & Crawford, 2010) 4-6 weeks prior to session, 4-6 weeks after session
Primary Change in Arc's Self-Determination Scale (SDS; Wehmeyer & Kelchner, 1995) 4-6 weeks prior to session, 4-6 weeks after session, and 12 month follow-up post-Program
Primary Change in Quality of Life Questionnaire (Shalock & Keith, 1993) 4-6 weeks prior to session, abridged version: 4-6 weeks after session and 12 month follow-up post-Program
Secondary Curriculum-specific workbook questions every week for 9 weeks at the end of group intervention meetings
Secondary Participant Program Evaluation Survey (Flanagan & Nadig, 2012) Questionnaire composed of qualitative (open-ended) questions 4-6 weeks after Program and 12 month follow-up post-Program
Secondary Parent Program Evaluation Survey (Flanagan & Nadig, 2012) (Questionnaire composed of quantitative (Likert-type) and qualitative (open-ended) questions) 4-6 weeks after Program
Secondary Questionnaire on vocational, educational and living situation outcomes 12 month follow-up post-Program
Secondary Communication task (Nadig, Vivanti, & Ozonoff, 2009) 4-6 weeks prior to session, 4-6 weeks after session
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