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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autism Spectrum Disorder

Learning Disabilities

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Mental Health

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]

Prevention

Intervention code [2]

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]

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]

At completion of the intervention,

Primary outcome [2]

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]

At completion of the intervention.

Secondary outcome [1]

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]

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]

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]

Parent mental health will be measured on three occasions: pre-treatment, post-treatment, and at 3-month follow-up.

Secondary outcome [3]

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]

Parent-teacher engagement will be measured on 3 occasions: pre-treatment, post-treatment, and 3-month follow-up.

Secondary outcome [4]

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]

Measures of child mental health will be taken pre-treatment, post-treatment, and at 3-month follow-up.

Secondary outcome [5]

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]

Measures of child social skills will be taken on 3 occasions: pre-treatment, post-treatment, and 3-month follow-up.

Secondary outcome [6]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Children's Hospital at Westmead

Address [1]

crn Hawkesbury Road and Hainsworth St
Westmead NSW 2145

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Autism Spectrum Australia

Address [2]

Building 1, Level 2
14 Aquatic Drive
Frenchs Forest NSW 2086

Country [2]

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]

Charities/Societies/Foundations

Name [1]

Autism Spectrum Australia

Address [1]

Building 1, Level 2
14 Aquatic Drive
Frenchs Forest NSW 2086

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Children's Hospitals Network Human Research Ethics Committee

Ethics committee address [1]

Research Office
The Children's Hospital at Westmead
crn Hawkesbury Rd and Hainsworth St
Westmead NSW 2145

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/08/2017

Approval date [1]

10/10/2017

Ethics approval number [1]

HREC/17/SCHN/347

Summary

Brief summary

One in 100 children is diagnosed with Autism. Up to 70% of children with Autism also experience mental illnesses including anxiety and depression. In addition to the impact of Autism on children, the mental illnesses they suffer from are of at least the same severity as that of their disability. However, unlike Autism, mental health problems are reversible and preventable. 

Emotion-based Social Skills Training (EBSST, also known as the Westmead Feelings Program) is a therapy program for children with Autism and co-occurring ID, their parents and teachers and includes a practitioner training and certification program. A controlled trial has demonstrated that school counsellor delivered EBSST improves emotions competence and reduces symptoms of mental disorder in children with ASD/ID. Utilising teachers in the delivery of mental health interventions is important given there are often barriers to therapy (such as cost, time, and travel) that prevent families from accessing much needed services. Additionally, school-based delivery can lead to positive changes within schools such as enhanced relationships between teachers, parents, and children. A pilot study demonstrated that special educator delivered EBSST is feasible and acceptable and results in qualitative improvements in child emotions competence and mental health.

The current project extends on these findings by investigating whether EBSST delivered by teachers in eight schools is acceptable and feasible from the perspective of children, parents and teachers. The project will also examine whether EBSST is associated with improvements in child emotions competence, social skills, and mental health symptoms post-treatment and at 3-month follow-up. For a subset of participants, the project will examine whether improvements in emotions competence, social skills, and mental health symptoms are different from a period of treatment-as-usual, compared to a period of EBSST delivery. The current project also examines the impact that EBSST has on the mental health of parents of children with ASD, who have been reported to experience high levels of stress and distress.

Sixteen teachers will be recruited to participate in the study to deliver EBSST to children in their classes and their parents. It is expected that approximately 75 children and 40 parents will participate. Teachers will deliver sixteen child EBSST sessions  and six parent EBSST sessions across three school terms. Teacher aides and parents will complete questionnaires about child emotions competence and child and parent mental health. Children will complete a questionnaire about how EBSST impacted their learning. It is hypothesised that teacher-delivered EBSST will be acceptable and feasible, and EBSST will be associated with concurrent improvements of child emotions competence, social skills, mental health, and parent mental health.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michelle Wong

Address

Dept Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61298452005

Fax

michelle.wong@health.nsw.gov.au

Contact person for public queries

Name

Michelle Wong

Address

Dept Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61298452005

Fax

michelle.wong@health.nsw.gov.au

Contact person for scientific queries

Name

Michelle Wong

Address

Dept Psychological Medicine
The Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145

Country

Australia

Phone

+61298452005

Fax

michelle.wong@health.nsw.gov.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.

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