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Trial registered on ANZCTR


Registration number
ACTRN12620000399998
Ethics application status
Approved
Date submitted
1/03/2020
Date registered
23/03/2020
Date last updated
23/03/2020
Date data sharing statement initially provided
23/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is adapted group cognitive behavioural therapy effective in treating anxiety for children and adolescents with intellectual disabilities?
Scientific title
Is adapted group cognitive behavioural therapy effective in treating anxiety for children and adolescents with intellectual disabilities?
Secondary ID [1] 300664 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 316460 0
Intellectual disabilities 316461 0
Condition category
Condition code
Mental Health 314707 314707 0 0
Learning disabilities
Mental Health 314782 314782 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single case design. 10 group therapy sessions using the Fearless Me! program. There will be 3-6 participants in each session. All sessions will be held at the University of Technology Sydney in Ultimo.
Upon making initial contact with the researchers, potential participants will be screened via a phone call with the parent/carer according to the inclusion and exclusion criteria. If eligible for the study, they will be provided with the information sheet and consent form and required to provide consent to participate in the study. The parent/carer will provide consent on behalf of the children.
During the intervention, the child and a parent/carer (does not need to be the same carer each time) will be required to attend weekly sessions. There will be 14 study visits in total: one pre-assessment session, ten intervention sessions, and one post intervention session, followed by a three-month follow-up assessment and twelve-month follow-up assessment. The first session, assessment session, the three and twelve-month follow-up and the qualitative interview will be in an individual format not group format (i.e. only the psychologist, child and carer present). The ten therapy sessions will be delivered in a group format. The Fearless Me! program developed by Hronis et al. (2018) was developed to specifically to treat children and adolescents with ID and anxiety. The Fearless Me! program is CBT adapted to meet the needs of children and adolescents with ID either individually or in a group.The Fearless Me! program targets the way children think, and the actions they take to improve their mood and reduce anxiety.
The Fearless Me! program consists of three modules:
1. Keep Calm
2. Stop and Think
3. Facing Fears
The Keep calm module involves children watching videos called Balloon Breathing and Squeeze and relax which teaches children relaxation strategies including progressive muscle relaxation and breathing. Stop and Think Module helps children identify and challenge their thoughts. Facing fears module focusses on helping children work towards their goals with small behavioural steps. Each module involves psycho-education, talking about their experiences and engaging in computer activities.
A feasibility study has shown early evidence for this treatment program (Hronis et al., 2018). The study investigated whether the Fearless Me! program would show reductions in measures of anxiety for children and adolescents with ID in a school setting. The program was delivered in a group format to classes of children with clinical and non-clinical anxiety, supported by School Learning Support Officers. The study was a case series and indicated the biggest reductions in measures of anxiety were in individuals with higher levels of anxiety at the study outset. This program will be used in a group setting, with sessions running weekly for 45-60 minutes each. Sessions will be run by a registered provisional psychologist and Clinical Psychologist.
Measures will include:
- Kaufman Brief Intelligence Test
- Developmental Behaviour Checklist (DBC; Einfeld & Tonge 1995)
- Spence Children’s Anxiety scale (SCAS; parent version and child brief version)
- Emotions Development Questionnaire (Wong et al., 2009)
- State Trait Anxiety Inventory for Children (Spielberger, 1973)
- Screen for Child Anxiety Related Disorders (Birmaher et al., 1997)
- Visual Mood Scale (child)
- Child Anxiety Life Interference Scale (CALIS)
- Paediatric Quality of Life Inventory (Ped-QL)
- Consumer Satisfaction Questionnaire.

There will also be a qualitative component to the post-treatment assessment. A semi-structured qualitative interview will be conducted at the post intervention time point. The interview guide will ask both the child and parent about their experience of the intervention including any positive or negative experiences and outcomes. Questions asked during the interviews may include: What was your experience of the program?; What parts of the program did you find valuable or helpful?; What parts of the program did you find not valuable or unhelpful?; and Are there any changes that we should make to the program?
Intervention code [1] 316992 0
Behaviour
Intervention code [2] 317065 0
Treatment: Other
Comparator / control treatment
There will be no control group. This study uses a case series design and each participant will be compared to their own baseline data.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 323049 0
Levels of anxiety and this interference with the child's life. To measure this, parents will be asked to complete the Spence Children’s Anxiety Scale (SCAS) (Parent Report) (Spence, 1998).
Timepoint [1] 323049 0
The initial interview with each participant will take place approximately 3 weeks prior to the start of the intervention. Two follow-up phone calls will take place 2 weeks and 1 week before the start of the intervention. The follow-up assessment will occur approximately 1 week after the last intervention session. There will be a 3 month and 12 month follow-up after the completion of the intervention.
Secondary outcome [1] 380615 0
Strengths and Difficulties Questionnaire (Goodman, 1997)
Timepoint [1] 380615 0
This will be administered during the initial assessment interview 3 weeks prior to the start of the intervention and the follow-up assessment, approximately 1 week after the last intervention session. There will also be a 3 month and 12-month follow-up after the completion of the intervention where this will be administered.
Secondary outcome [2] 381308 0
Developmental Behavior Checklist 2 (DBC-2) (Einfeld & Tonge, 2018)
Timepoint [2] 381308 0
This will be administered during the initial assessment interview 3 weeks prior to the start of the intervention and the follow-up assessment, approximately 1 week after the last intervention session. There will also be a 3 month and 12-month follow-up after the completion of the intervention where this will be administered.
Secondary outcome [3] 381309 0
Child Anxiety Life Interference Scale (CALIS Parent Version) (Langley et al., 2004)
Timepoint [3] 381309 0
This will be administered during the initial assessment interview 3 weeks prior to the start of the intervention and the follow-up assessment, approximately 1 week after the last intervention session. There will also be a 3 month and 12-month follow-up after the completion of the intervention where this will be administered.
Secondary outcome [4] 381310 0
The Emotions Development Questionnaire – Parent Version (Wong, Heriot & Lopes, 2009),
Timepoint [4] 381310 0
This will be administered during the initial assessment interview 3 weeks prior to the start of the intervention and the follow-up assessment, approximately 1 week after the last intervention session. There will also be a 3 month and 12-month follow-up after the completion of the intervention where this will be administered.
Secondary outcome [5] 381311 0
Paediatric Quality of Life Inventory (Varni, Seid & Kurtin, 2001).
Timepoint [5] 381311 0
This will be administered during the initial assessment interview 3 weeks prior to the start of the intervention and the follow-up assessment, approximately 1 week after the last intervention session. There will also be a 3 month and 12-month follow-up after the completion of the intervention where this will be administered.
Secondary outcome [6] 381312 0
Kaufman Brief Intelligence Test.
Timepoint [6] 381312 0
This will be administered during the initial assessment interview 3 weeks prior to the start of the intervention.
Secondary outcome [7] 381313 0
State-Trait Anxiety Inventory for Children (Spielberger, 1973),
Timepoint [7] 381313 0
This will be administered during the initial assessment interview 3 weeks prior to the start of the intervention and the follow-up assessment, approximately 1 week after the last intervention session. There will also be a 3 month and 12-month follow-up after the completion of the intervention where this will be administered.
Secondary outcome [8] 381314 0
Screen for Child Anxiety Related Disorders (Birmaher et al., 1997),
Timepoint [8] 381314 0
This will be administered during the initial assessment interview 3 weeks prior to the start of the intervention and the follow-up assessment, approximately 1 week after the last intervention session. There will also be a 3 month and 12-month follow-up after the completion of the intervention where this will be administered.
Secondary outcome [9] 381315 0
Visual Mood Scale (child)
Timepoint [9] 381315 0
This will be administered during the initial assessment interview 3 weeks prior to the start of the intervention and the follow-up assessment, approximately 1 week after the last intervention session. There will also be a 3 month and 12-month follow-up after the completion of the intervention where this will be administered.
Secondary outcome [10] 381316 0
Consumer Satisfaction Questionnaire.
Timepoint [10] 381316 0
At follow-up interview, approximately 1 week post-intervention.

Eligibility
Key inclusion criteria
8-18 years old when the intervention is started.
Intellectual disability - borderline, mild or moderate.
Low levels of risk.
Anxiety.
Be able to attend weekly sessions.
Access to a computer or tablet.
Minimum age
8 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
High risk.
No access to a computer or tablet.
No anxiety.
Severe or profound intellectual disability.

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Single case design in which each participant's levels of anxiety are compared to their baseline measures.
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Visual analysis and reliable change index.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 305087 0
University
Name [1] 305087 0
University of Technology Sydney
Address [1] 305087 0
Building 20, 100 Broadway Ultimo NSW 2007
Country [1] 305087 0
Australia
Funding source category [2] 305128 0
Charities/Societies/Foundations
Name [2] 305128 0
James N Kirby Foundation
Address [2] 305128 0
Level 2/86-90 Bay St, Ultimo NSW 2007
Country [2] 305128 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
Building 20, 100 Broadway Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 305466 0
None
Name [1] 305466 0
None
Address [1] 305466 0
None
Country [1] 305466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305479 0
UTS Human Research Ethics Committee (HREC)
Ethics committee address [1] 305479 0
15 Broadway, Ultimo NSW 2007
Ethics committee country [1] 305479 0
Australia
Date submitted for ethics approval [1] 305479 0
03/10/2019
Approval date [1] 305479 0
06/02/2020
Ethics approval number [1] 305479 0
ETH19-4268

Summary
Brief summary
The proposed research aims to evaluate the Fearless Me! program, a CBT program specifically designed for children with ID and anxiety in a clinical group setting. The program was designed to be applied in an individual or group format. Thus far, the program has been evaluated with moderate success in a group format in a school setting, with clinical and non-clinical presentations (Hronis, et al. 2019). Fearless Me! is currently being assessed in an individual format for children with anxiety and ID, however, the program has not been tested in a clinical sample through a group format.

It is hypothesised that the intervention will result in better mental health outcomes, including reduced levels of anxiety, improved quality of life and improved emotional development.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 100506 0
Prof Ian Kneebone
Address 100506 0
Level 8 Building 20 UTS, 100 Broadway Chippendale NSW 2007

Country 100506 0
Australia
Phone 100506 0
+61 2 95144280
Fax 100506 0
Email 100506 0
Ian.Kneebone@uts.edu.au
Contact person for public queries
Name 100507 0
Ms Freya Wright
Address 100507 0
Level 8 Building 20 UTS, 100 Broadway Chippendale NSW, 2007
Country 100507 0
Australia
Phone 100507 0
+61431775619
Fax 100507 0
Email 100507 0
13441884@student.uts.edu.au
Contact person for scientific queries
Name 100508 0
Ms Freya Wright
Address 100508 0
Level 8 Building 20 UTS, 100 Broadway Chippendale NSW, 2007
Country 100508 0
Australia
Phone 100508 0
+61431775619
Fax 100508 0
Email 100508 0
13441884@student.uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Data from pre-assessment and post-assessment parent and child questionnaire results.
When will data be available (start and end dates)?
At the conclusion of the study, no end date determined.
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator, by emailing the Principal Investigator.
Freya Wright, email: 13441884@student.uts.edu.au
What supporting documents are/will be available?
Study protocol
Informed consent form
How or where can supporting documents be obtained?
Type [1] 7154 0
Study protocol
Citation [1] 7154 0
Link [1] 7154 0
Email [1] 7154 0
Ian.Kneebone@uts.edu.au
Other [1] 7154 0
Type [2] 7155 0
Informed consent form
Citation [2] 7155 0
Link [2] 7155 0
Email [2] 7155 0
Ian.Kneebone@uts.edu.au
Other [2] 7155 0
Summary results
No Results