Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000136202
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
30/01/2018
Date last updated
9/01/2020
Date data sharing statement initially provided
29/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Westmead Feelings Program Trial for Children with Autism and Intellectual Disability in Special Education Schools
Scientific title
An Acceptability and Feasibility Study of the Westmead Feelings Program for Children with Autism and Intellectual Disability in Special Education Schools
Secondary ID [1] 293765 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 306158 0
Learning Disabilities 306159 0
Condition category
Condition code
Mental Health 305270 305270 0 0
Autistic spectrum disorders
Mental Health 305271 305271 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Emotion-based Social Skills Training, also known as the Westmead Feelings Program 1: emotion-based learning for children with Autism Spectrum Disorder and Intellectual Disability (WFP 1) is a mental health promotion intervention that teaches children with Autism Spectrum Disorders and Intellectual Disabilities emotion competence skills and reduces anxious and depressive symptomatology. Three modules comprise of WFP 1: 1) understanding emotions, 2) problem solving and perspective taking, and 3) managing emotions. WFP comprises of sessions for children, and sessions for parents and teachers so they can become emotion coaches for their children and promote the generalization and maintenance of skills across situations and time.

Sessions are delivered by facilitators who are educators with experience supporting children with Autism Spectrum Disorder who have completed two-days of WFP Training and Certification to ensure knowledge, competence and skills are developed to deliver WFP. The WFP intervention is a manualised, 16-session group-based intervention for children which consists of evidence-based teaching strategies known to benefit children with Autism Spectrum Disorder including video modelling, social scripts, role plays, and take home tasks. Children are given workbooks that summarise session content. Child sessions last for one hour, and conducted face-to-face on a weekly basis by WFP facilitators for 5 weeks per WFP module, with a two week break between modules, and 1 booster session three months later. Parent sessions consist of manualised psychoeducation and skills-based training around understanding the impact of Autism on the emotion skills and wellbeing of their child and how to utilise WFP teachings in home and community environments. Six parent sessions are delivered face-to-face by WFP facilitators and are of 1-hour duration. Parent sessions are held at the beginning and end of each of three WFP modules with a booster session three months later. Parents are given presentation handouts of each session they attend to summarise session content, as well as weekly handouts summarising what their child learnt in their session and who parents can promote generalisation and practice of session content at home and in the community.

Fidelity of WFP delivery will be checked by a research psychologist in 13% of the sample (i.e. two sites) using a session fidelity checklist which describes the content to be covered in sessions and strategies/activities to be utilised. One child session and one parent session will be checked for fidelity.
Intervention code [1] 300020 0
Prevention
Intervention code [2] 300080 0
Treatment: Other
Comparator / control treatment
This is a single-arm study with one group. This group will act as their own control group, with measures comparing a treatment as usual period, to a period of receiving WFP. The treatment as usual period will be 4 weeks. Treatment as usual consists of the Personal Development and Physical Health lessons included in the normal school curriculum.
Control group
Active

Outcomes
Primary outcome [1] 304440 0
Acceptability of teacher-implemented WFP1, as measured by items on the "Teacher Questionnaire" designed specifically for this study. Acceptability will be measured by the percentage of teachers who scored >4 on acceptability items measured on a 5-point likert scale.
Timepoint [1] 304440 0
At completion of the intervention,
Primary outcome [2] 304494 0
Feasibility of teacher-implemented WFP1, as measured by items on the "Teacher Questionnaire" designed specifically for this study. Feasibility will be measured by the percentage of teachers who scored >4 on feasibility items measured on a 5-point likert scale.
Timepoint [2] 304494 0
At completion of the intervention.
Secondary outcome [1] 341939 0
Child wellbeing as measured by the child-completed Friendship Questionnaire (adapted for this study from the Friendship Qualities Scale, Bukowski, Hoza & Boivin, 1994) and Student Questionnaire (developed for this study). Child wellbeing will be measured as the percentage of children who scored 3 on child wellbeing items measured on a 3-point likert scale. Child wellbeing is also measured by the parent and teacher aide completed Parent Questionnaire (developed for this study) and Teacher Aide Questionnaire (developed for this study). Child wellbeing on Parent and Teacher Aide Questionnaires will be measured by the percentage of parents/teachers who scored >4 on child wellbeing items measured on a 5-point likert scale.
Timepoint [1] 341939 0
Child-reported measures of child wellbeing are taken on 5 occasions: pre-treatment, during treatment at the end of Module 1, during treatment at the end of Module 2, post-treatment, and at 3-month follow-up. Parent and teacher aide measures of child wellbeing are taken post-treatment and at 3-month follow-up.
Secondary outcome [2] 341940 0
Parent mental health as measured by the Depression Anxiety Stress Scales (Lovibond & Lovibond, 1995) as the percentage of parents with depression, anxiety or stress subscale scores that are above clinical cut-offs.
Timepoint [2] 341940 0
Parent mental health will be measured on three occasions: pre-treatment, post-treatment, and at 3-month follow-up.
Secondary outcome [3] 341941 0
Parent-teacher engagement as measured on the Teacher Questionnaire (developed for this study), and Parent Questionnaire (developed for this study). Parent-teacher engagement will be measured by the percentage of parents/teachers who scored >4 on parent-teacher engagement items measured on a 5-point likert scale.
Timepoint [3] 341941 0
Parent-teacher engagement will be measured on 3 occasions: pre-treatment, post-treatment, and 3-month follow-up.
Secondary outcome [4] 342139 0
Child mental health as measured by the Developmental Behaviour Checklist (Einfield & Tonge, 2002) and Child Behaviour Checklist (Achenbach & Rescorla, 2001). Child mental health will be indicated by the percentage of children with total and subscale scores that are above clinical cut-offs. Outcomes will be measured as the proportion of participants with changes in mental health scores.
Timepoint [4] 342139 0
Measures of child mental health will be taken pre-treatment, post-treatment, and at 3-month follow-up.
Secondary outcome [5] 342140 0
Child social skills as measured by the Social Skills Improvement Scale (Gresham & Elliott, 2008) completed by parents and teacher aides, Teacher Aide Questionnaire (developed for this study), and Parent Questionnaire (developed for this study). Outcomes on the Social Skills Improvement Scale will be measured as the proportion of participants with changes in social skills subscale and total scores. Child social skills as reported on the Teacher Aide Questionnaire and Parent Questionnaire will be measured by the percentage of parents/teachers who scored >4 on child social skills items measured on a 5-point likert scale.
Timepoint [5] 342140 0
Measures of child social skills will be taken on 3 occasions: pre-treatment, post-treatment, and 3-month follow-up.
Secondary outcome [6] 342141 0
Child emotions competence as measured on the Emotions Development Questionnaire (Wong, Heriot & Lopes), Emotion Regulation Checklist (Shields & Cicchetti, 1997). Outcomes will be measured as the proportion of participants with changes in emotions competence scores.
Timepoint [6] 342141 0
Measures of child emotions competence will be taken on 3 occasions: pre-treatment, post-treatment, and at 3-month follow-up.

Eligibility
Key inclusion criteria
Child participants: a suspected or confirmed diagnosis of Autism Spectrum Disorder and enrolled in an Autism Spectrum Australia school classroom of a teacher participant where the majority of children have a cognitive ability between 50 and 75.
Parent participants: parent of a participating child. Up to two parents or carers per child will be invited to participate in this study.
Teacher participants: NSW Aspect school classroom teachers of children with ASD/ID at the time of the study. Teachers will be prioritised who have higher numbers of students within the specified IQ range in their class.
Minimum age
8 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Parent participants: difficulties understanding the English language. WFP sessions and questionnaires contain content including psychological concepts that are difficult for people to understand if they have difficulties with the English language.

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



Intervention assignment
Other design features
Not applicable.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
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.

Associations between treatment and study outcomes will be described by within-participant changes over time. These 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 subject will be used where required.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/02/2018
Actual
12/02/2018
Date of last participant enrolment
Anticipated
1/05/2018
Actual
1/05/2018
Date of last data collection
Anticipated
29/03/2019
Actual
27/12/2019
Sample size
Target
75
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 298381 0
Hospital
Name [1] 298381 0
The Children's Hospital at Westmead
Country [1] 298381 0
Australia
Funding source category [2] 298391 0
Charities/Societies/Foundations
Name [2] 298391 0
Autism Spectrum Australia
Country [2] 298391 0
Australia
Primary sponsor type
Hospital
Name
The Children's Hospital at Westmead
Address
crn Hawkesbury Road and Hainsworth St
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 297507 0
Charities/Societies/Foundations
Name [1] 297507 0
Autism Spectrum Australia
Address [1] 297507 0
Building 1, Level 2
14 Aquatic Drive
Frenchs Forest NSW 2086
Country [1] 297507 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299374 0
Sydney Children's Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 299374 0
Ethics committee country [1] 299374 0
Australia
Date submitted for ethics approval [1] 299374 0
30/08/2017
Approval date [1] 299374 0
10/10/2017
Ethics approval number [1] 299374 0
HREC/17/SCHN/347

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

Contacts
Principal investigator
Name 80214 0
Dr Michelle Wong
Address 80214 0
Dept Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 80214 0
Australia
Phone 80214 0
+61298452005
Fax 80214 0
Email 80214 0
[email protected]
Contact person for public queries
Name 80215 0
Michelle Wong
Address 80215 0
Dept Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 80215 0
Australia
Phone 80215 0
+61298452005
Fax 80215 0
Email 80215 0
[email protected]
Contact person for scientific queries
Name 80216 0
Michelle Wong
Address 80216 0
Dept Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country 80216 0
Australia
Phone 80216 0
+61298452005
Fax 80216 0
Email 80216 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
All participant data has been deidentified and will be analyzed and reported as group data.


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
No additional documents have been identified.