Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001267145
Ethics application status
Approved
Date submitted
21/08/2019
Date registered
12/09/2019
Date last updated
5/02/2020
Date data sharing statement initially provided
12/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Transition program for adolescents and young adults with autism in Australia
Scientific title
Development and Evaluation of a Transition to Adulthood Program for Adolescents and Young Adults with Autism in Australia
Secondary ID [1] 299070 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autism spectrum disorders 314103 0
Condition category
Condition code
Neurological 312478 312478 0 0
Other neurological disorders
Mental Health 312479 312479 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The TRANSITION program was developed in Sweden specifically for adolescents and adults with Autism Spectrum Disorders. The program aimed at improving adult transition outcomes of young people with autism in major life areas of employment, education community participation and quality of life. The TRANSITION program runs for 24 weeks and consists of a combination of group-based workshops covering important adult life domains and a mentor program. During the initial session, TRANSITION participants meet individually with their assigned mentor to discuss their current situation, formulate goals and action plans. Following the initial meeting, the participants will take part in weekly group based workshops, each involving 10 participants and two facilitators. The group workshops will cover seven life domains such as work, education, finances, housing, health, leisure/participation in society and relationships/social networks. Each group will include a presentation on one of two life domains, and group discussions. After the 5-week face-to-face group workshops, participants will meet with their mentor on a weekly basis for four months. Mentoring meetings can be conducted face-to-face, phone call, SMS, or email communication (approximately 30 minutes to 1 hour each meeting). The mentoring sessions will focus on facilitating the participants to work towards their goals and completing their personalised action plans. Mentoring meetings are completed in an individual setting.

The mentors and facilitators running the TRANSITION program are required to have clinical expertise in autism, specifically professionals with a background in psychology, occupational therapy, special education, speech pathology or social work. TRANSITION mentors and facilitators will receive training to deliver the group and mentoring components of the TRANSITION program. The training will be conducted by the Swedish developers of the TRANSITION program, approximately 1-2 months prior to the intervention commencement. This training will be a one-off workshop, over 3 days (approximately 7.5 hours each day).

TRANSITION mentors and group facilitators are required to complete a Fidelity Scale after each session, to assess program adherence. Ongoing supervision will also be provided.
Intervention code [1] 315339 0
Treatment: Other
Intervention code [2] 315340 0
Behaviour
Comparator / control treatment
Participants allocated to the control group will receive no intervention or 'usual care' (participants continuing the interventions they are currently receiving).
Control group
Active

Outcomes
Primary outcome [1] 321121 0
Quality of life: Assessment Quality of Life- 8D (AQoL-8D) measures physical and psychosocial quality of life. It has five dimensions, containing 35 items relating to independent living, pain, senses, mental health, happiness, coping, relationships and self-worth.
Timepoint [1] 321121 0
Timepoint 1: Week 0 (pre-intervention), 2: Week 24 (post-intervention)-primary timepoint and 3(12 months post completion of intervention)
Secondary outcome [1] 374054 0
Environment support (facilitators and barriers): The Measure of the Quality of the Environment (MQE) evaluates facilitators and barriers in the environment impacting on participation outcomes.
Timepoint [1] 374054 0
Timepoint 1: Week 0 (pre-intervention), 2: Week 24 (post-intervention) and 3(12 months post completion of intervention)
Secondary outcome [2] 374677 0
Adaptive functioning: Adaptive Behavior Assessment System – 3rd Edition (ABAS-3) Assess adaptive skills, including communication, community use, functional academics, home living, health and safety, leisure, self-care, self-direction, social, work.
Timepoint [2] 374677 0
Timepoint 1: Week 0 (pre-intervention), 2: Week 24 (post-intervention) and 3(12 months post completion of intervention)
Secondary outcome [3] 379594 0
Self-efficacy will be measured using the Generalized self-efficacy scale (GSE), providing a measure of global self-efficacy and problem solving.
Timepoint [3] 379594 0
Timepoint 1: Week 0 (pre-intervention), 2: Week 24 (post intervention) and 3 (12 months post completion of intervention)
Secondary outcome [4] 379595 0
Health: EQ-5D-5L is an assessment of participants health rating. Comprise of five dimensions; mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Timepoint [4] 379595 0
Timepoint 1: Week 0 (pre-intervention), 2: Week 24 (post intervention) and 3 (12 months post completion of intervention)
Secondary outcome [5] 379596 0
Anxiety and depression: The Hospital Anxiety and Depression Scale is a questionnaire to measure the levels of anxiety and depression.
Timepoint [5] 379596 0
Timepoint 1: Week 0 (pre-intervention), 2: Week 24 (post intervention) and 3 (12 months post completion of intervention)

Eligibility
Key inclusion criteria
Individuals aged 16 to 30 years old
Clinical consensus of diagnosis of ASD as defined by the Diagnostic Statistical Manual of Mental Disorders version 5 or IV, sighted via participants' diagnostic reports and confirmed with clinically significant scores on the Social Responsiveness Scale (SRS)
Intellectual quotient scores > 70 as measured by the Wechsler Abbreviated Scale of Intelligence- Second Edition (WASI-II)
Minimum age
16 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Insufficient English language skills
Presence of intellectual disability as measured using the Weschler Abbreviated Scale of Intelligence-II (i.e. participants scoring below the 70 threshold will be excluded)
Severe depressive symptoms (e.g. presence of suicidal ideation) using the Suicidal Ideation Attributes Scale (SIDAS)

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)
Allocation will be conducted following completion of baseline assessments. The administrators at Therapy Focus (facilitators of the TRANSITION program) will contact the holder of the allocation schedule who is "off-site" to the administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by an online number generator
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Approximately 48 participants will be recruited in the pilot feasibility trial. Based on the analysis of estimations of effect sizes using Cohen’s d (ß-value of 0.8 and a-value of 0.05), a
standardised difference of 0.8 or larger will be detectable with 24 participants in each group. This would ensure that the study is adequately powered to detect a large effect size for all the outcomes.

The target number of participants for the randomised controlled trial is 90 participants. A minimum of 56 participants would be required to detect an large Cohen effect size of 0.8 with a ß-value of 0.9 and a-value of 0.05, However, based on previous studies, a sample of 90 participants would be sufficient to detect any significant findings.


Statistical analysis will be conducted to compare the performance between both groups. A Kolmogorov-Smirnov test will be firstly used to determine the distribution of the data. Following to this, univariate analyses using a Mann-Whitney U test or an independent t-test will be used to determine association between the primary and secondary outcomes. Multivariate analyses will then be conducted using modelling to account for the repeated measures contributed by each participant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
6/01/2020
Date of last participant enrolment
Anticipated
1/08/2022
Actual
Date of last data collection
Anticipated
31/12/2023
Actual
Sample size
Target
90
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment postcode(s) [1] 27620 0
6102 - Bentley

Funding & Sponsors
Funding source category [1] 303605 0
Government body
Name [1] 303605 0
Department of Communities
Country [1] 303605 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Kent Street, Bentley, Perth, Western Australia 6102
Country
Australia
Secondary sponsor category [1] 303696 0
Other
Name [1] 303696 0
Therapy Focus
Address [1] 303696 0
1140 Albany Highway, Suite 5, Bentley Plaza, Bentley WA 6102
Country [1] 303696 0
Australia
Other collaborator category [1] 280916 0
Other
Name [1] 280916 0
Karolinska Institute - Center for Neurodevelopmental Disorders at Karolinska Institute (KIND)
Address [1] 280916 0
CAP Research Center
Gävlegatan 22 (Entré B), floor 8
SE-11330 Stockholm, Sweden
Country [1] 280916 0
Sweden

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304134 0
Curtin University Human Research Ethics Office
Ethics committee address [1] 304134 0
Ethics committee country [1] 304134 0
Australia
Date submitted for ethics approval [1] 304134 0
19/08/2019
Approval date [1] 304134 0
23/09/2019
Ethics approval number [1] 304134 0
HRE2019-0633

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

Contacts
Principal investigator
Name 95926 0
Prof Sonya Girdler
Address 95926 0
School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Kent Street, Bentley, Perth, Western Australia 6102
Country 95926 0
Australia
Phone 95926 0
+61 8 9266 3630
Fax 95926 0
Email 95926 0
[email protected]
Contact person for public queries
Name 95927 0
Sonya Girdler
Address 95927 0
School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Kent Street, Bentley, Perth, Western Australia 6102
Country 95927 0
Australia
Phone 95927 0
+61 8 9266 3630
Fax 95927 0
Email 95927 0
[email protected]
Contact person for scientific queries
Name 95928 0
Sonya Girdler
Address 95928 0
School of Occupational Therapy, Social Work and Speech Pathology, Curtin University, Kent Street, Bentley, Perth, Western Australia 6102
Country 95928 0
Australia
Phone 95928 0
+61 8 9266 3630
Fax 95928 0
Email 95928 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approval has not been obtained to published individual participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4157Study protocol    Study protocol will be published as a journal arti... [More Details]
4158Informed consent form    378217-(Uploaded-19-08-2019-19-52-21)-Study-related document.docx



Results publications and other study-related documents

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

Documents added automatically
No additional documents have been identified.