Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001474842
Ethics application status
Approved
Date submitted
14/09/2021
Date registered
28/10/2021
Date last updated
6/07/2023
Date data sharing statement initially provided
28/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Preliminary study of The Feelings Program for Autistic Adolescents with Mild Intellectual Disability delivered in Aspect Secondary School Classes to explore feasibility, participant experience and the effect on social emotional domains and mental health concurrent with delivery of the adapted Westmead Feelings Program group intervention.
Scientific title
Preliminary study of The Feelings Program for Autistic Adolescents with Mild Intellectual Disability (ID) delivered in Aspect Secondary School Classes to explore feasibility, participant experience and improvements in social emotional domains and mental health concurrent with delivery of the adapted Westmead Feelings Program (WFP) group intervention.
Secondary ID [1] 305311 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 323626 0
Intellectual disability 323627 0
Condition category
Condition code
Mental Health 321161 321161 0 0
Autistic spectrum disorders
Mental Health 321162 321162 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Feelings Program - Adolescent Version (TFP-A) was adapted from the Westmead Feelings Program (WFP) by the WFP author group for an adolescent target audience, with a diagnosis of autism spectrum disorder and co-occurring mild intellectual disability (ID).
In this single arm, within-subjects intervention study, in 2022, TFP-A will be delivered to students enrolled in a secondary autism-specific school-based setting (selected Autism Spectrum Australia (Aspect) Secondary School Classes).
Based on previous studies we have conducted in over 65 NSW schools and 8 Aspect Schools, TFP-A will be delivered in classroom groups as part of the normal PDHPE curriculum. A recent study of WFP in Aspect primary schools with children 7-12 years old indicated that it was feasible to conduct the program in the classroom setting and that it helped to fill a gap in the PDHPE curriculum. Furthermore, Aspect Schools also recognised a need for a similar program adapted for secondary school students. Aspect Schools will be asked to nominate school psychologists and teachers to assist in the implementation of TFP-A in their School secondary classes. Previous studies of WFP1 have found that teachers can facilitate the WFP.

Aspect staff, including school psychologist, school coordinators and experienced educators will facilitate TFP-A. Teaching staff will also provide positive behaviour support and learning support in their role as co-facilitators. There may be between 3-10 students in each class. All members of the class will be invited to attend the TFP-A sessions. All sessions will be facilitated by a psychologist or experienced educator (with at least 5 years experience working with autistic adolescents with mild ID). The Aspect facilitators will be trained by authors of WFP to become facilitators of TFP-A. Facilitator training will include a total of 10 hours of training (via zoom) held over 3 days. Training will include 7 hours over 2 days in Term 4, 2021 and 3 hours on one day in Term 1, 2022. To pass the training, staff need to achieve 80% or above on an online quiz and demonstrate competence in delivering the program through a 10min video demonstration task.
The manualised program provides step by step instructions on how to run the group and includes paper-based and computer-based visual supports and audio-video content. TFP-A consists of 18-20 sessions, each of 60 minute during, held fortnightly. It is expected that the program will start in Term 1, 2022 and will be completed in Term 4, 2022. The booster session will be held in Term 2, 2023. TFP-A is grouped into 3 modules covering 1) identifying and expressing emotions, 2) problem solving and perspective taking and 3) emotional regulation. A booster session will be held 6 months after the last clinical session and is a review and consolidation of the material already covered in the program. The booster session will be for 60 minutes. Co-facilitators will be asked to complete an implementation checklist of during the sessions as a measure of fidelity.
In the group intervention sessions student participants will engage in a class lesson which includes watching videos, discussing the content of videos and completing worksheets based on their own examples. For example in lesson 1 students watch a video to learn about good and not-so-good feelings, they then have a class discussion on different good and not-so-good feelings, followed by completing a worksheet that consolidates their learning. They are then asked to complete a worksheet based on their own example. At the end of each lesson students are given takeaway tasks based on the same worksheet. It is expected that worksheet will require 15 minutes to complete, with the support of a parent / carer in the home environment. All worksheets will be reviewed by the facilitators and co-facilitators to ensure that students are completing the worksheets accurately, and that students understand the material being taught. There are consolidation sessions at the end of each module which can provide facilitators time to support additional learning. There are two versions of worksheets available for facilitators to use, a basic version and a more complex version. All students will be provided with both worksheets in the first module, however based on progress and accurate completion of the worksheet, students will be provided with the worksheet that best meets their learning needs in Module 2 and Module 3 (ie reduced cognitive content).
TFP-A is held at school in class-time for students, however there is also separate online parent content. The online parent program will include videos, written resources and guidance to develop their skills as emotion coaches for their child. There will also be opportunities for parents to meet with other parents in an online session, facilitated by TFP-A facilitators. The aim of the parent sessions is also to build parent capacity and confidence in supporting their child's emotional needs in a home and community context. This will include using the strategies and language taught in TFP-A. Parents will be invited to attend a face to face session (or online session if required by general health recommendations during the global pandemic) before the commencement of the program (in Term 1, 2022). Parents will be provided training on the purpose of TFP-A and their role as an emotion coach. They will be introduced to the online training program and taught how to access the program and the elements covered over the year in TFP-A. Each fortnight over the course of TFP-A (Term 1, Term 2 and Term 3) parents will be asked to complete short online training modules, each one lasting for 10-30 minutes. There are 10 modules in total covering generalisation of skills in autism, emotion communication, recognising emotion body signs, recognising emotion-based behaviour, linking situations, thoughts and feelings, problem solving, perspective taking and a range of emotion regulation strategies. There will also be an additional 5 modules that focus on the role of the parent regarding parent attunement, modeling emotion regulation, mindfulness, parenting teenagers and trouble shooting. Each online training module will have a learning check with 2-3 questions to assess if a parent has grasped the concepts being taught. Parents will also be asked to attend a group training session at the start of each Term to provide them with additional support and opportunity to practice new skills with the facilitator. Face to face session will be for 1 hour duration. It is asked that parents complete all the online training sessions and attend the 3 face to face parent sessions. Attendance records will be kept of group sessions and progress of online material will be accessed through the learning management system (LMS).
Intervention code [1] 321720 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328955 0
Determine if the TFP-A is feasible based on feedback from adolescents, their parents and teachers in both a 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] 328955 0
Feasibility questionnaire conducted at the end of each of the 3 modules and 6 month follow up booster session with adolescents (Term 1, Term 2 and Term 3, 2022 & Term 1, 2023)
Feasibility questionnaire conducted at the end of 18-20 sessions (post-treatment, end of Term 3, 2022) and at 6 month follow up with parents and teachers (end of Term 1, 2023).
Primary outcome [2] 328956 0
Evaluate changes in adolescent participants in individually developed social-emotional goals concurrent with the delivery of TFP-A.

Goal Attainment Scale (GAS) goals will be individually developed in collaboration with teachers and parents for each participant, including two goals in the home and one goal in the school context. The GAS goal is developed to create a measurable and achievable goal for each participant with defined outcomes of current skill (0), expected improvement (+1), greater than expected improvement (+2), and decline of skill (-1) and greater than expect decline in skill (-2). This scale is developed with the researcher, teacher and parent.

Change will be described on a case-by-case basis using pre- and post-treatment scores, with a score of 0 meaning there was no change, 1 meaning there was improvement as expected, and 2 meaning there was a greater than expected improvement. Conversely a score of -1 would indicate a decline in skill area and -2 would be a greater than expected decline in skill. Percentage change scores will also be described.
Timepoint [2] 328956 0
Baseline - pre-treatment (By Term 1 2022)
Post-treatment (after 18th session, at the end Term 3, 2022)
Primary outcome [3] 329148 0
Evaluate changes in adolescent participants in emotions competence concurrent with the delivery of TFP-A and at 6 month follow up.

Behavioural Emotional Competency Child and Adolescent Task (BECCA Task; Wong, Ford, Gardner & Dossetor, 2021) is an observation based assessment of emotional competence including use of emotion communication, emotion regulation and emotional perspective taking.

Change on sub-scales in the 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] 329148 0
Baseline - pre-treatment (By Term 1 2022)
Post-treatment (after 18th session, at the end Term 3, 2022)
Secondary outcome [1] 400944 0
Explore any parent and teacher reported changes in social-cognition (the ability to think about the social implications of emotions in others and impact of own behaviour) to determine if there is any change after attending TFP-A.

Change will be reported in terms of change in clinical significance levels in the SRS2 (Social Cognition subscale).

Change will be described on a case-by-case basis using pre- and post-treatment scores and 6 month follow up. Percentage change scores will also be described.
Timepoint [1] 400944 0
Baseline - pre-treatment (By Term 1 2022)
Post-treatment (after 18th session, at the end Term 3, 2022)
6 month follow up (Term 1, 2023)
Secondary outcome [2] 401646 0
Evaluate changes in adolescent participants in parent and teacher reported emotions competence concurrent with the delivery of TFP-A and at 6 month follow up..

Emotions Development Questionnaire (EDQ; Wong, Lopes & Heriot, 2009) has been previously designed by researchers exploring earlier studies to assess change in the level of emotional competence for participants, as reported by parents and teachers.

Change on the EDQ will be described on a case-by-case basis using pre- and post-treatment, and 6 month follow up scores as a total score and also in each of the four domains (emotional expression, emotion regulation, problem solving and perspective taking). Percentage change scores will also be described.
Timepoint [2] 401646 0
Baseline - pre-treatment (By Term 1 2022)
Post-treatment (after 18th session, at the end Term 3, 2022)
6 month follow up (Term 1, 2023)
Secondary outcome [3] 401649 0
Explore any parent (CBCL) reported changes in anxiety, depression and aggression to determine if there is any change after attending TFP-A.

Change will be reported in terms of change in clinical significance levels in the CBCL (Anxiety, Depression and Aggression subscales).

Change will be described for each sub-scale on a case-by-case basis using pre- and post-treatment scores and 6 month follow up. Percentage change scores will also be described.. Percentage change scores will also be described.
Timepoint [3] 401649 0
Baseline - pre-treatment (By Term 1 2022)
Post-treatment (after 18th session, at the end Term 3, 2022)
6 month follow up (Term 1, 2023)
Secondary outcome [4] 402388 0
Explore any teacher (TRF) reported changes in anxiety, depression and aggression to determine if there is any change after attending TFP-A.

Change will be reported in terms of change in clinical significance levels in the TRF (Anxiety, Depression and Aggression subscales).

Change will be described for each sub-scale on a case-by-case basis using pre- and post-treatment scores and 6 month follow up. Percentage change scores will also be described.. Percentage change scores will also be described.
Timepoint [4] 402388 0
Baseline - pre-treatment (By Term 1 2022)
Post-treatment (after 18th session, at the end Term 3, 2022)
6 month follow up (Term 1, 2023)

Eligibility
Key inclusion criteria
The selected Aspect School Secondary classes will be chosen based on the consent of the School Principal. School Principals will take into consideration the number of students that meet the inclusion criteria; Adolescents aged 11-16 years old with a mild Intellectual Disability (IQ between 50 and 75) who are enrolled to attend an Aspect School secondary class in 2022 (Year 7-11 in 2022).

Students on the autism spectrum often have complex presentations, and it is likely that classes may include students with a variety of support needs, including emotional, intellectual and physical impairments. Students who attend but do not have a mild intellectual disability will be asked to consent to participating in the study, but will be reported on separately .
Minimum age
11 Years
Maximum age
16 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All student in the class who have the consent of parents to participate in the study will be included. Parent who do not consent to being a part of the study will be excluded from the parent component of the program and no data will be collected on their child.

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 study. All participants will receive the same intervention, but it will be delivered by different facilitators and across different classed in Aspect Schools. Each group will participate in the sessions in class during Personal Development, Health and Physical Education lessons, delivered by a TFP-A trained Aspect staff member.

The implementation study aims to recruit 30 autistic adolescents with co-occurring mild ID. Each group will include 3-10 participants which are within the maximum numbers for effective clinical group delivery and maximum numbers for school-based group delivery. Although the minimum number for effective clinical group delivery is 3, as the sessions are being held in a school-based setting it is not anticipated that class sizes will be that small. The program will aim to facilitate 5-8 groups over the school year. The final number will depend on how many families consent the study and meet criteria, as well as how many staff Aspect are willing to be trained as a facilitator of TFP-A and released to conduct the sessions. However, it is anticipated that students from two Aspect Schools in NSW will be invited to participate in the study.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Based on similar studies previously conducted by DPT, 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.

The sample size of 30 participants has been selected primarily on practical considerations.

A study of 30 participants will have 80% power at 5% two-sided alpha to detect a large change of 0.75 standard deviations in a continuous measure using a paired t-test, assuming a low level of correlation between pre- and post-program measures in the same participant. Our previous studies have observed SDs of up to 18 in EDQ scores, so a change of 0.75 SDs is equivalent to a change of 13.5 points on a scale with a range of 100 points. However, the primary purpose of the study is to describe outcomes rather than formal hypothesis testing. The single-arm study design is a limitation, but promising findings will provide support for a larger study and estimates for the study design.

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 variation 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, Vineland.

Associations between treatment and study outcomes will be described by within-participant changes over time. Within-participant changes over time in the outcome measures will be presented with 95% confidence intervals. Exploratory analyses will examine associations between participant characteristics and study outcomes. Statistical models that take into account the potential correlation between repeated observations in the same participant will be used where required.

Outcome measures for which clinical cut-offs are available, will be used to categorise participants at baseline and after the program as well as report on percentage who experience clinically significant change.

Quantitative data to determine if the program has been viewed as being feasible will be analysed in the following way:
• For parents and teachers, quantitative data will be collected from questions that ask participants to provide ratings about the level of effort or burden required to be involved in TFP-A (including location, time of day), elements of the TFP-A (teaching techniques, language, facilitators) individual child factors (group program, communication and learning support needs) and their reported experience of the materials, involvement, and benefit of the TFP-A. These measures, aimed at collecting information regarding feasibility, will be on a 5-point likert scale, where 5 = very positive. A mean score on any one item equal to or above 4 will indicate acceptable feasibility.
• For adolescents, quantitative data will be collected from number of children recruited, consented, attendance records, retention in the program and completion of youth workbook tasks. Adolescent participants will also be asked questions about whether a skill or technique is feasible/helpful on a 3-point likert scale, where 3 = very feasible/helpful. A mean score on any one item of 3 will indicate that a skill or technique is feasible or helpful.
In the event that a particular skill or technique is found to not be feasible or unhelpful, questionnaires ask participating adolescents, parents and professionals to provide reasons for why they scored the item negatively. The TFP-A program content may be adjusted to take account of this feedback, or may indicate that further testing is needed on a larger sample size to better understand the concerns raised.

To determine feasibility, should 80% of participants respond positively (score of 4 or 5 for 5 point Likert scale, or score of 3 on a 3 point Likert scale) we will conclude the domain being assessed is feasible. If a domain is not assessed to be feasible, we will utilize qualitative data to inform program adjustments.

Quantitative data to determine if the program has been effective, will be analysed in the following ways:
• Information at pre-treatment assessment with the adolescent and their parent will include the development of two Goal Attainment Scales (GAS) based on the individually identified social emotional goals of each adolescent participant in the home/community context. Social-emotional goals also form a part of the Individual Education Plan at Aspect Schools. An additional school-based GAS will be developed with the teacher based on the individually identified social emotional goals of each adolescent participant in the school context. This is an approach frequently used in clinical research where standardised assessment measures are not sensitive enough to measure change or have not been developed to be used with adolescents on the autism spectrum with a mild ID. The GAS provides a scale from which to evaluated meaningful change in a child’s skills. At pre-treatment a scale is developed which provides observable behaviours in which to determine the individuals projected level of progress on goals that are personally meaningful and relevant. At post intervention each goal is assessed against the scale to determine if there has been no change (0), an expected improvement (1), a larger than expected improvement (2) or a small decline (-1) or large decline in the skill (-2).
• The analysis will be primarily descriptive and there will be no formal adjustment made for multiple statistical comparisons.
• For parents and teachers, quantitative data will be collected from questions that ask participants to provide ratings regarding the perceived benefits and the level of effort or burden required to be involved in TPF-A (including location, time of day), elements of the TFP-A (teaching techniques, language, facilitators) individual child factors (group program, communication and learning support needs) and their reported experience of the materials, training, and their involvement of TFP-A. These measures, aimed at collecting information regarding feasibility and acceptability of the program, on a 5-point likert scale, where 5 = very positive. A mean score on any one item equal to or above 4 will indicate acceptability.
Qualitative data drawn from the questionnaires and evaluation focus groups will be analysed using a thematic approach. A content analysis of sample student workbooks and behaviour assessment of emotional competence will be conducted in order to triangulate the findings regarding skill development.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/11/2021
Actual
2/12/2021
Date of last participant enrolment
Anticipated
31/03/2022
Actual
31/03/2022
Date of last data collection
Anticipated
1/05/2023
Actual
23/06/2023
Sample size
Target
30
Accrual to date
Final
28
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 20516 0
The Children's Hospital at Westmead - Westmead
Recruitment postcode(s) [1] 35294 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 309678 0
Hospital
Name [1] 309678 0
The Children's Hospital at Westmead
Country [1] 309678 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] 310700 0
Charities/Societies/Foundations
Name [1] 310700 0
Autism Spectrum Australia (Aspect)
Address [1] 310700 0
PO Box 361
Forestville, NSW 2087
Country [1] 310700 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309445 0
Sydney Children's Hospitals Network HREC
Ethics committee address [1] 309445 0
Ethics committee country [1] 309445 0
Australia
Date submitted for ethics approval [1] 309445 0
05/02/2021
Approval date [1] 309445 0
27/04/2021
Ethics approval number [1] 309445 0
2021/ETH00168

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

Contacts
Principal investigator
Name 114186 0
Mrs Anita Gardner
Address 114186 0
Department of Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, NSW, 2145
Country 114186 0
Australia
Phone 114186 0
+61 401036103
Fax 114186 0
Email 114186 0
[email protected]
Contact person for public queries
Name 114187 0
Anita Gardner
Address 114187 0
Department of Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, NSW, 2145
Country 114187 0
Australia
Phone 114187 0
+61 0298452005
Fax 114187 0
Email 114187 0
[email protected]
Contact person for scientific queries
Name 114188 0
Anita Gardner
Address 114188 0
Department of Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead, NSW, 2145
Country 114188 0
Australia
Phone 114188 0
+61 0298452005
Fax 114188 0
Email 114188 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Preliminary data will be available at the end of the intervention study (December 2022). Participants have also been asked to provide consent for de-identified data to be stored indefinitely in a secure online server at The Children's Hospital at Westmead. There is no end date for the availability of that data, however all other research data will be stored as per the Hospital policy, until such time as the youngest participant is 25 years old OR 15 years after publication of the research, whichever is the longest.
Available to whom?
De-identified data may be shared with universities or research partners where there is a research agreement signed and endorsed by The Sydney Children's Hospitals Network Governance and the Department of Psychological Medicine.
Available for what types of analyses?
The data will be available for any analysis that aims to achieve the aims in the approved proposal.
How or where can data be obtained?
Anyone wishing to obtain data will need to contact the research investigators at the Department of Psychological Medicine, The Children's Hospital at Westmead. To do so, they must email the principal investigator, Anita Gardner at [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13187Study protocolGardner, Wong & Ratcliffe (2020). A preliminary study of The Feelings Program for Autistic Adolescents with Mild Intellectual Disability. (Study Protocol) The Children's Hospital at Westmead; Sydney, Australia. [email protected] On request by email
13188Informed consent form  [email protected] On request by email
13189Clinical study report  [email protected] On request by email (once study is concluded).
13190Ethical approval  [email protected] On request by email



Results publications and other study-related documents

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