Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000081213
Ethics application status
Approved
Date submitted
9/01/2018
Date registered
19/01/2018
Date last updated
9/11/2021
Date data sharing statement initially provided
9/11/2021
Date results provided
9/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Westmead Feelings Program pilot study for adolescents with autism and mild intellectual disability
Scientific title
Pilot study of the Westmead Feelings Program 1 adapted for adolescents with autism and mild intellectual disability to explore feasibility, participant experience and improvements in social emotional domains and mental health concurrent with delivery of the adapted WFP group intervention in a clinical and school based pilot.
Secondary ID [1] 293645 0
Nil known
Universal Trial Number (UTN)
U1111-1206-8065
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 305930 0
Intellectual disability 305931 0
Condition category
Condition code
Mental Health 305126 305126 0 0
Autistic spectrum disorders
Mental Health 305127 305127 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is a multi-centre intervention study based in a clinical setting and a mainstream school, support unit class.
Westmead Feelings Program 1 (WFP1, Ratcliffe et al. 2017) is the first therapy program for children with ASD/ID aimed at improving emotional intelligence and emotions competence with a focus on preventing mental illness. WFP1 teaches children with ASD/ID skills in emotions understanding, perspective taking and problem solving, and emotions management. Parents and teachers are delivered sessions to provide them with strategies to scaffold learning in home and school environments. Previous studies have shown the effectiveness of WFP where children with ASD showed significantly improved emotions competence and reduced mental health symptoms both post treatment and at 6-month follow-up (e.g. Ratcliffe et al., 2014; Ratcliffe et al., under review). However, in those studies, WFP was delivered to children. Given the potential benefits to adolescents and the need for programs that can be implemented for young people on the spectrum who also have a mild intellectual disability, this study aims to explore the lived experience of adolescents with Autism and mild ID, their emotional and social needs and to develop an adaptation of the WFP1 to be trialed in a clinical and school based pilot study.
WFP1 is a manualised program which consists of 16 group session of 60-90 minute duration each. The sessions involve discussion, teaching of new skills, video modelling, role play and completion of worksheets. Evidence based autism support strategies such as the use of visual supports and positive behaviour support are utilized in the delivery of the program. There are 3 modules of 5 sessions each and 1 booster session at 6 months follow up. One module will be conducted per school term (for the clinical trial - Term 2, 3 & 4 in 2018; for the school trial Term 1, 2 & 3 in 2019) with weekly session followed by a break between school terms. The program content teaches adolescent participants about their feelings (eg happy, sad, angry and worried), perspective taking, problem solving and emotional regulation strategies to assist them when they feel not so good emotions.
The program will be delivered by the researchers who are all psychologists or a social worker. They have each had over 10 years working with young people with autism and intellectual disabilities. One researcher shall attend the sessions as an observer to make notes regarding program content and adherence to the program. A checklist of the activities to be conducted at each session shall be created to assist the facilitators in implementing the program and for the observer to use to assess fidelity. At the end of each session the researchers shall review the checklist and make adjustments for the next session if required.
Clinic Pilot - There will be 3-6 adolescents in this pilot study. Adolescent participants must have a minimum of a phrase level of expressive verbal communication skills and a minimum ability to follow short simple sentences and instructions. Information regarding communication skills and social skills will also be collected through a background information questionnaire to parents and adolescents. Throughout the study, questionnaires will be used to collect data on the variables of interest and will be completed by adolescent, parent and teacher participants.
School based pilot - Based on previous studies we have conducted in over 60 NSW schools, the WFP1 adapted for adolescents school-based pilot will be delivered in one classroom group as part of the normal PDHPE curriculum. Many support unit classes have students with a variety of support needs, including emotional, intellectual and physical impairments. All members of the class will be invited to attend the WFP1 adapted for adolescents sessions. Students who attend but do not have Autism or an intellectual disability will also be asked to consent to participating in the study. The class teacher will also be invited to attend the WFP sessions and consent to being a part of the study. Questionnaires will be used to collect data on the variables of interest and will be completed by adolescent, parent and teacher participants.
As part of both the clinical and school trial, parents will also be invited to attend 3 WFP parent information sessions (at the beginning, at the end of the 16 sessions and at 6 months follow up). The sessions will be held by the researchers (psychololgists and/or social worker).
During WFP sessions, questionnaires will be completed by adolescents on four occasions (during the final sessions of WFP Module 1, Module 2, Module 3, and the Booster Session) to maximize the reliability and validity of adolescent self-reports.
Intervention code [1] 299907 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304289 0
Determine if the small sample pilot study of the adapted WPF is feasible based on feedback from adolescents, their parents and teachers in both a clinical and school based setting. Feasibility will be assessed by a researcher-developed questionnaire, with adolescent, parent and teacher versions. Feasibility as reported by adolescents will be measured on a 3-point Likert Scale, where a mean score of three indicates feasibility. Feasibility as reported by parents and teachers will be measured on a 5-point Likert Scale, where a mean score of four or five indicates feasibility.
Timepoint [1] 304289 0
Feasibility questionnaire conducted at the end of each of the 3 modules and 6 month follow up booster session with adolescents (Term 2, Term 3 and Term 4, 2018 & Term 2, 2019)
Feasibility questionnaire conducted at the end of 15 sessions (post-treatment, end of Term 4, 2018) and at 6 month follow up with parents and teachers (end of Term 2, 2019).
Primary outcome [2] 304290 0
Determine if the experience of attending the adapted WPF was positive, based on feedback from adolescents in both a clinical and school based setting, Positive experience will be assessed by a researcher-developed questionnaire adolescent versions. Positive experience as reported by adolescents will be measured on a 3-point Likert Scale, where a mean score of three indicates a positive experience of the program element being measured.
Timepoint [2] 304290 0
Questionnaires related to the adolescent participant's experience of the adapted WFP will be conducted at the end of each of the 3 modules and 6 month follow up booster session with adolescents (Term 2, Term 3 and Term 4, 2018 & Term 2, 2019)
Primary outcome [3] 304365 0
Evaluate changes in adolescent participants in emotions competence concurrent with the delivery of the adapted WFP and at 6 month follow up.
Emotions Development Questionnaire (Wong, Lopes & Heriot, 2009) has been previously designed by researchers exploring earlier versions of WFP to assess change in the level of Emotional Competence for participants, as reported by parents and teachers.
Change on each outcome measure will be described on a case-by-case basis using pre- and post-treatment scores. Percentage change scores will also be described.
Timepoint [3] 304365 0
Baseline - pre-treatment (early Term 2, 2018)
Post-treatment (after 15th session, at the end Term 4, 2018)
6 month follow up (Term 2, 2019)
Secondary outcome [1] 341513 0
Explore the association between parent mental health and adolescent emotions competence, social skills and wellbeing to determine if there is any correlation between the depression, anxiety and stress scores for parents on the DASS-42 (Lovibond & Lovibond, 1995) to measures from the primary outcomes for adolescents as described above.
Timepoint [1] 341513 0
Baseline - pre-treatment (early Term 2, 2018)
Post-treatment (after 15th session, at the end Term 4, 2018)
6 month follow up (Term 2, 2019)
Secondary outcome [2] 342042 0
Determine if the experience of attending the adapted WPF was positive, based on feedback from the parents of the adolescent participants in both a clinical and school based setting, Positive experience will be assessed by a researcher-developed questionnaire - parent version. Positive Experience as reported by parents will be measured on a 5-point Likert Scale, where a mean score of four or five indicates a positive experience of the program element being measured.
Timepoint [2] 342042 0
Questionnaires related to the parents experience of the adapted WFP will be conducted at the end of 15 sessions (post-treatment, end of Term 4, 2018) and at 6 month follow up parent session (end of Term 2, 2019).
Secondary outcome [3] 342043 0
Determine if the experience of attending the adapted WPF was positive, based on feedback from the teachers of the adolescent participants in both a clinical and school based setting, Positive experience will be assessed by a researcher-developed questionnaire - teacher version. Positive Experience as reported by teachers will be measured on a 5-point Likert Scale, where a mean score of four or five indicates a positive experience of the program element being measured.
Timepoint [3] 342043 0
Questionnaires related to the teacher experience of the adapted WFP will be sent out to teachers at the end of 15 sessions (post-treatment, end of Term 4, 2018) and at 6 month follow up (end of Term 2, 2019).
Secondary outcome [4] 342044 0
Evaluate changes in adolescent participants social skills concurrent with the delivery of the adapted WFP and at 6 month follow up.
Changes in social skills and friendships will be assessed by parent and teacher report on the Social Skills Improvement Scale (Gresham & Elliott, 2008) and the adolescent self report of the Friendships Questionnaire adapted by the researchers, Wong & Gibbs (2017) from the Friendship Qualities Scale (Bukowski, Hoza & Boivin, 1994).
Change on each outcome measure will be described on a case-by-case basis using pre- and post-treatment scores, clinical cut-off scores. Percentage change scores will also be described.
Timepoint [4] 342044 0
Baseline - pre-treatment (early Term 2, 2018)
Post-treatment (after 15th session, at the end Term 4, 2018)
6 month follow up (Term 2, 2019)
Secondary outcome [5] 342045 0
Evaluate changes in adolescent participants wellbeing, concurrent with the delivery of the adapted WFP and at 6 month follow up.
Changes in adolescent wellbeing will be assessed using parent and teacher reports from the Developmental Behaviour Checklist (Einfield & Tonge, 2002), Emotion Regulation Checklist (Shields & Cicchetti, 1997), Emotion Deregulation Index (derived from the Child Behaviour Checklist, Achenbach, 2001), and the WellSEQ adolescent self report measure of Wellbeing (English version currently being developed and tested in collaboration with the researchers and the developers of the original Swedish version, Bostrom & Erikkson, 2015).
Change on each outcome measure will be described on a case-by-case basis using pre- and post-treatment scores, clinical cut-off scores. Percentage change scores will also be described.
Timepoint [5] 342045 0
Baseline - pre-treatment (early Term 2, 2018)
Post-treatment (after 15th session, at the end Term 4, 2018)
6 month follow up (Term 2, 2019)

Eligibility
Key inclusion criteria
Adolescent participants: Adolescents eligible to participate in the Clinic pilot of the adapted WFP study will be 12-16 years old with a diagnosis of ASD and IQ between 50 and 75. Confirmation of diagnosis will be through assessments conducted by staff at Children's Hospital Westmead, Department of Psychological Medicine using the ADOS2, SRS, ABAS3 and WISC5. As indicated on the parent background information questionnaire, adolescent participants must have a minimum of a phrase level of expressive verbal communication skills and a minimum ability to follow short simple sentences and instructions.
All participants must speak English and be willing to attend the clinic sessions.
The Support Unit selected for inclusion in the adapted WFP school based pilot will be selected through communications with the NSW Department of Education, Learning and Wellbeing Officer, who will recommend one appropriate high school with a suitable support unit class. The selected class will be in a mainstream (regular) school and may also include students that do not have ASD and/or Mild ID. For the purpose of this study the recommendations of the Learning and Wellbeing Officer will be of a Support Unit that is comprised of at least 4 adolescent students (aged 12-16) that have ASD and Mild Intellectual Disability all of whom have parental consent to participate in the study.
Adolescent participants: Adolescents eligible to participate in the school based pilot will be aged 12-16 years old and attend the Support Unit class. Once consent is given, the school counsellor will review student files to confirm a previous diagnosis of ASD and IQ between 50 and 75. Confirmation of severity will be through ABAS-3 and SRS assessment completed by parents. Parents and teachers will provide feedback on the adolescent participant’s expressive and receptive communication skills as well as outcome measures.
The school based pilot is a whole classroom intervention with students allocated to classes based on a range of disability criteria. It may be that students with an IQ below 50 and above 75 or students without an ASD diagnosis are members of the class invited to participate. These students will be also invited to participate in the research project and class sessions. Given adolescent participants will be recruited from one class taught by one class teacher, it may be that the burden of the teacher completing questionnaires on all participating students is too great to allow for participation and quality data collection. The Principal Information Sheet states that educators who are familiar with participating adolescents to the extent that they are able to reliably report on their emotion and social skills can complete questionnaires for this study. This may be a class teacher, teacher’s aide, Assistant Principal, or Well-being Coordinator.
Note: All parents of students in the support unit class will be invited to consent for the research study, involving the collection of data relating to the adapted WFP. If parents of the school pilot do not consent for their child to participate in this research study, their child will still receive the adapted WFP. Data will not be collected on non-consenting participants.
Minimum age
12 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
In the clinical pilot adolescent participants who are reported to have high levels of reported challenging behaviour, high levels of attention difficulties, are non-verbal (or very little verbal communication) and have been previously reported to have moderate to severe mental health issues will be exclude from the trial. WFP is delivered in a group format in a clinic setting which requires participants to be comfortable in settings where there is a level of verbal communication required. As the WFP is a mental health prevention program, if current mental health difficulties are too great it may limit the ability of the participant to participate in the program or benefit from the skill building elements of the program when delivered in a group format in a clinic setting.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Implementation, multi-centre study. All participants will receive the same intervention. One group will attend the group intervention in a clinical setting, the other group will participate in the sessions in class during Personal Development, Health and Physical Education lessons.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The clinic pilot will consist of 3-6 adolescent participants, which is the minimum and maximum numbers for effective clinical group delivery. The final number will depend on how many families are interested in being a part of the program, can attend 16 sessions at the selected clinic site and meet criteria.
The school based pilot will be held at a Department of Education school in a support unit class. Based on information from the Department of Education, Support Unit sizes that enrol high school students with ASD and/or Mild ID vary in size from a maximum of seven students (autism only class) to 18 students (mild intellectual disability class in a mainstream school). There would need to be a minimum of four participating students in the class with ASD and Mild ID for this study to be feasible. The school based program will be delivered to the whole class. Students that do not have ASD and Mild ID will still attend the sessions and will be invited to consent to being a part of the study. We estimate that it is likely that there will be 6 students in total who will consent to being part of the study.
Based on similar studies previously conducted, once participants are committed to the therapeutic program, response rates have been high (90-100%). We assume that data will be collected from at least 90% of the participating students who attend the pilot school-based program.
Therefore, Part C of the study is likely to have approximately 10 adolescents in total participating.
The study recognizes that the small sample size is a limitation in concluding whether or not the WFP adapted for adolescents is feasible / a positive experience. For example, even if all of the first 10 participants find the program feasible, it is still possible that the true rate of the not feasible outcome could be as high as around 25%.
The large amount of data collected, through questionnaires, for each participant is required to ensure that the study follows good research methods and uses recognised research reliable assessment tools. The burden to participants matches the potential benefits that will be gained as a result of this pilot study. Due to the real world nature of this research study, it was only financially possible to fund 2 test sites for the pilot program. A positive result in this study will most likely result in testing the program with a larger sample size.
The study shall collect and analysis quantitative and qualitative data.
For quantitative data, the analysis will be descriptive; given this is a pilot study with a small sample size. Participant characteristics, study outcomes, and other variables will be described using standard statistical methods: frequencies and percentages for categorical variables and mean (standard deviation) or median (interquartile range) for continuous variables. There may be significant differences within the profile of individual adolescent participant’s cognitive ability (e.g. Verbal IQ in the mild range of disability, Performance IQ in the borderline range of disability, and adaptive skills in the mild range of disability) as described by the WISC5, ABAS, or school counselor file review. Differences will be reported using the standard statistical methods described above. Pre- and post-treatment scores on outcome measures will be described on a case by case basis - clinical cut-offs for outcome measures, where available, will be used to describe clinically significant change, and percentage change scores will be described. Feasibility and experience of the WFP will be measure using likert scales. On a 5 point scale, a mean score on any one item equal to or above 4 will indicate acceptable feasibility / experience. On a 3 point scale, a mean score on any one item equal to 3 will indicate acceptable feasibility / experience.
Qualitative data will be analysed using a thematic approach. “Thematic analysis is a method for identifying, analysing, and reporting patterns (themes) within data” (Braun & Clark, 2006, p7). An essentialist or realist method will be used, involving an inductive approach to generate themes which report on the experiences, meanings and the reality of participants’ responses. This is a data driven approach whereby alignment between participant opinion can be identified, in addition to where differences lie. Individual responses will be grouped into themes which are presented in tables to demonstrate this alignment and differences.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/02/2018
Actual
5/03/2018
Date of last participant enrolment
Anticipated
30/11/2018
Actual
5/03/2019
Date of last data collection
Anticipated
30/04/2020
Actual
30/10/2020
Sample size
Target
38
Accrual to date
Final
38
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9689 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 18458 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 298262 0
Hospital
Name [1] 298262 0
The Children's Hospital at Westmead
Country [1] 298262 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
Locked Bag 4001
Westmead, NSW 2145
Country
Australia
Secondary sponsor category [1] 297454 0
Hospital
Name [1] 297454 0
Sydney Children's Hopitals Network
Address [1] 297454 0
Locked Bag 4001
Westmead, NSW, 2145
Country [1] 297454 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299265 0
Sydney Children's Hospitals Network Human Research Ethics Committee (EC00130)
Ethics committee address [1] 299265 0
Ethics committee country [1] 299265 0
Australia
Date submitted for ethics approval [1] 299265 0
20/10/2017
Approval date [1] 299265 0
15/11/2017
Ethics approval number [1] 299265 0
HREC/17/SCHN/386
Ethics committee name [2] 299330 0
State Education Research Applications Process (SERAP)
Ethics committee address [2] 299330 0
Ethics committee country [2] 299330 0
Australia
Date submitted for ethics approval [2] 299330 0
27/12/2017
Approval date [2] 299330 0
Ethics approval number [2] 299330 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 2318 2318 0 0
/AnzctrAttachments/374195-Ethics approval letter - 15 Nov 2017 - Exec officer 13 Nov 2017.pdf (Ethics approval)
Attachments [2] 2320 2320 0 0
/AnzctrAttachments/374195-Teaching social emotional skills to school ages children with autism.pdf (Publication)

Contacts
Principal investigator
Name 79838 0
Mrs Anita Gardner
Address 79838 0
Department of Psychological Medicine
The Children's Hospital Westmead
Locked Bag 4001
Westmead, NSW, 2145
Country 79838 0
Australia
Phone 79838 0
+61 2 9845 2005
Fax 79838 0
+61 2 9845 2009
Email 79838 0
[email protected]
Contact person for public queries
Name 79839 0
Anita Gardner
Address 79839 0
Department of Psychological Medicine
The Children's Hospital Westmead
Locked Bag 4001
Westmead, NSW, 2145
Country 79839 0
Australia
Phone 79839 0
+61 2 9845 2005
Fax 79839 0
+61 2 9845 2009
Email 79839 0
[email protected]
Contact person for scientific queries
Name 79840 0
Anita Gardner
Address 79840 0
Department of Psychological Medicine
The Children's Hospital Westmead
Locked Bag 4001
Westmead, NSW, 2145
Country 79840 0
Australia
Phone 79840 0
+61 2 9845 2005
Fax 79840 0
+61 2 9845 2009
Email 79840 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
Beyond the scope of ethics approval


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14018Ethical approval  [email protected]
14019Study protocol  [email protected]
14020Informed consent form  [email protected]
14021Clinical study report  [email protected]



Results publications and other study-related documents

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