Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615000119594
Ethics application status
Approved
Date submitted
21/01/2015
Date registered
10/02/2015
Date last updated
9/03/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Planning the Transition to Employment for Adolescents with High Functioning Autism/Asperger's Syndrome
Scientific title
Planning the Transition to Employment for Adolescents on the Autism Spectrum: Development of the Better OutcOmes & Successful Transitions for Autism (BOOST-A) Program
Secondary ID [1] 286026 0
Nil
Universal Trial Number (UTN)
Trial acronym
Better OutcOmes & Successful Transitions for Autism (BOOST-A)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Conditions 293999 0
Condition category
Condition code
Mental Health 294294 294294 0 0
Autistic spectrum disorders
Physical Medicine / Rehabilitation 294295 294295 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is the Better OutcOmes & Successful Transitions for Autism (BOOST-A). The BOOST-A is an online protocol that will guide adolescents with high functioning autism/Asperger's Syndrome (HFA/AS) to plan their transition from school to employment. This will be done with the adolescent's 'transition team', which includes their parents/carers, relevant school staff, and any other professionals involved in their transition planning. The protocol has a strengths and interests based assessment, which will provide guidance on potential job pathways for the adolescent. It also assists with goal setting to promote engagement in activities to increase the likelihood that the adolescent will be successful in obtaining employment post-school. The protocol was developed based on a literature review of best-practice in transition planning, as well as a survey and interviews of adolescents with HFA/AS, their parents/carers and professionals about the ideal transition planning process.

The protocol involves a number of phases:
Phase 1 and 2: Preparation and Assessment. Duration is 1-2 hours. Completed online with the adolescent and the parent.
Phase 3: Goal setting. Done with the team at a meeting that would run for about 1 hour.
Phase 4: Review. Done with the team at a recurring meeting that will run for 0.5-1 hour.

Time frame:
Overall duration of intervention: Roughly 3-4 years (from Year 9 to Year 12). The current RCT will monitor 1 year of this process.
Phase 1 & 2: Over a period of 2 weeks.
Phase 3: Within 1 month of completing Phase 1 & 2 (by Week 6).
Phase 4: The meetings are held once a term, or every 3 months, for the period of roughly 3 years.

Strategies used to monitor adherence to the intervention include monitoring participant's usage of the online program (which stored data in a central database). Participants will also be asked to report on how often they've used the protocol and with whom.
Intervention code [1] 291009 0
Rehabilitation
Intervention code [2] 291064 0
Behaviour
Comparator / control treatment
The control/comparator group is the 'Treatment As Usual' Group. This group will engage in the standard transition planning practice for adolescents with HFA/AS, which is typically initiated by parents or the school staff. This may include: academic skill development, preparation for higher education, engagement in vocational education or training or work experience.
Control group
Active

Outcomes
Primary outcome [1] 294097 0
Outcomes Related to Successful Employment Post-School

This is a questionnaire developed by the researchers. It contains questions about different elements of transition planning (the have been linked in the literature to good post-school outcomes), asking the participants to rate their agreement with each question on a Likert scale of 1 to 7.
Timepoint [1] 294097 0
Baseline measure (0 months), halfway measure (6 months), and final measure (12 months).
Primary outcome [2] 294098 0
AIR Self-Determination Scale
Timepoint [2] 294098 0
Baseline measure (0 months), halfway measure (6 months), and final measure (12 months).
Primary outcome [3] 294099 0
Career Development Inventory – Australia – Short Form
Timepoint [3] 294099 0
Baseline measure (0 months), halfway measure (6 months), and final measure (12 months).
Secondary outcome [1] 312507 0
Learning Climate Questionnaire
Timepoint [1] 312507 0
Baseline measure (0 months), halfway measure (6 months), and final measure (12 months).
Secondary outcome [2] 312508 0
Personal Wellbeing Index
Timepoint [2] 312508 0
Baseline measure (0 months), halfway measure (6 months), and final measure (12 months).

Eligibility
Key inclusion criteria
Adolescents (N=80) with a diagnosis of HFA/AS who are in Year 8, 9, 10 or 11 at school in 2015.
Minimum age
13 Years
Maximum age
19 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals with co-morbid conditions will be excluded if they are deemed to introduce distinctly different characteristics from ASD that would potentially require additional consideration in post-school pathway planning.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A cluster RCT will be undertaken. Each local government area will be allocated to the protocol or control group. The area that the participant's school is in will determine whether they are in the protocol or control group. Participants will be asked to provide their school name when expressing interest in participating in the study, and at this point they will be randomised.

Allocation is not concealed (as it is done by postcode).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be used to generate the sequence in which each local government area will be allocated to either protocol or control group. This will involve computerised sequence generation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Group equivalence at baseline will be determined based on gender, socioeconomic status and ASD symptoms. The sample size allows for detection of a Cohen’s d (standardized difference) of 0.6 or larger with a beta-level of 0.2 and an a-level of 0.05. Outcomes will be analysed using a t-test and/or Mann-Whitney U depending on whether they outcomes use scale or ordinal variables. ANOVA will be used to analyse the difference; within individuals, within groups and between the groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
2/03/2015
Actual
15/06/2015
Date of last participant enrolment
Anticipated
Actual
20/11/2015
Date of last data collection
Anticipated
Actual
26/01/2017
Sample size
Target
80
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 290617 0
Commercial sector/Industry
Name [1] 290617 0
The Cooperative Research Centre for Living with Autism Spectrum Disorders (Autism CRC)
Country [1] 290617 0
Australia
Funding source category [2] 290618 0
University
Name [2] 290618 0
Curtin University
Country [2] 290618 0
Australia
Primary sponsor type
Individual
Name
Torbjorn Falkmer
Address
Level 3 Building 401
School of Occupational Therapy and Social Work
Curtin University
Kent Street
Bentley
Western Australia
6102
Country
Australia
Secondary sponsor category [1] 289303 0
Individual
Name [1] 289303 0
Marita Falkmer
Address [1] 289303 0
Level 2 Building 400
School of Occupational Therapy and Social Work
Curtin University
Kent Street
Bentley
Western Australia
6102
Country [1] 289303 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292247 0
Human Research Ethics Committee Curtin University
Ethics committee address [1] 292247 0
Ethics committee country [1] 292247 0
Australia
Date submitted for ethics approval [1] 292247 0
29/04/2014
Approval date [1] 292247 0
16/06/2014
Ethics approval number [1] 292247 0
HR 110/2014

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54306 0
Prof Torbjorn Falkmer
Address 54306 0
Level 3 Building 401
School of Occupational Therapy and Social Work
Curtin University Kent Street Bentley Western Australia 6102
Country 54306 0
Australia
Phone 54306 0
+61 8 9266 9051
Fax 54306 0
Email 54306 0
[email protected]
Contact person for public queries
Name 54307 0
Marita Falkmer
Address 54307 0
Level 2 Building 400
School of Occupational Therapy and Social Work
Curtin University Kent Street Bentley Western Australia 6102
Country 54307 0
Australia
Phone 54307 0
+61 8 9266 3605
Fax 54307 0
Email 54307 0
[email protected]
Contact person for scientific queries
Name 54308 0
Torbjorn Falkmer
Address 54308 0
Level 3 Building 401
School of Occupational Therapy and Social Work
Curtin University Kent Street Bentley Western Australia 6102
Country 54308 0
Australia
Phone 54308 0
+61 8 9266 9051
Fax 54308 0
Email 54308 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEvaluation of the effectiveness of an online transition planning program for adolescents on the autism spectrum: Trial protocol.2016https://dx.doi.org/10.1186/s13034-016-0137-0
EmbaseEffectiveness of the BOOST-ATM online transition planning program for adolescents on the autism spectrum: A quasi-randomized controlled trial.2017https://dx.doi.org/10.1186/s13034-017-0191-2
EmbaseProcess Evaluation of the BOOST-ATM Transition Planning Program for Adolescents on the Autism Spectrum: A Strengths-Based Approach.2018https://dx.doi.org/10.1007/s10803-017-3317-8
N.B. These documents automatically identified may not have been verified by the study sponsor.