The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000434190
Ethics application status
Approved
Date submitted
6/03/2019
Date registered
18/03/2019
Date last updated
18/03/2019
Date data sharing statement initially provided
18/03/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fearless Me!: A Pilot Randomised Controlled Trial (RCT) of an Innovative Treatment Program for Children with Intellectual Disability and Anxiety
Scientific title
Fearless Me!: A Pilot Randomised Controlled Trial (RCT) of an Innovative Treatment Program for Children with Intellectual Disability and Anxiety
Secondary ID [1] 297625 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
intellectual disability 311916 0
anxiety 311917 0
Condition category
Condition code
Mental Health 310498 310498 0 0
Anxiety
Mental Health 310499 310499 0 0
Learning disabilities

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This research aims to trial the Fearless Me! program to see whether Cognitive Behaviour
Therapy is an effective treatment for anxiety in children with intellectual disabilities. The Fearless Me! program has been specifically adapted for the needs of children with intellectual disabilities in the mild, moderate and borderline ranges.

Data will be collected from parents/carers and children participating. The materials used will be:
- Spence Anxiety Questionnaire (parent version and child version)
- Strengths and Difficulties Questionnaire (parent version and child version)
- Child Anxiety Life Interference Scale
- Developmental Behaviour Checklist
- Emotions Development Questionnaire
- Visual Analogue Rating scale of anxiety
- Kaufmann Brief Intelligence Test
- Paediatric Quality of Life Inventory
- Screen for Child Anxiety Related Disorders

Parents/carers will make contact with the research team and complete a screener to assess for suitability in the program. This will involve confirmation of a mild or moderate intellectual disability, or IQ in the borderline range. Children are required to be between 8 - 18 years of age (inclusive), with anxiety concerns and no active self harm/suicidality. Parents will complete the screen for child anxiety related disorders.

There will be an initial assessment session, followed by ten weekly therapy sessions, and then a follow up assessment session post treatment. There will also be a three month and 12 month follow up. All sessions (therapy and assessments) will be conducted by psychologists with either provisional or full registration, and be involved in weekly supervision sessions. The Kaufmann Brief Intelligence Test will be used as a screen of intellectual functioning.
For those in the waitlist control group, they will receive the initial assessment, wait ten weeks, and then complete the follow up assessment, before then receiving the treatment.

The weekly therapy sessions will consist of cognitive behaviour therapy treatment. This will involve teaching children to identify, distinguish between and link their thoughts, emotions and behaviours. This will be done using the online program and tasks which have been created to practice this skill. The program will also involve setting behavioural goals to overcome fears, and the teaching of relaxation strategies. The website will be used at home to monitor progress with the behavioural goals, practice the skill of identifying unhelpful thinking styles and challenging these thoughts, as well as access to videos which demonstrate relaxation techniques. It is expected that children/parents will use the program at home for approximately 1 hour per week. Additional use is at the parents discretion.

The intervention will mostly be delivered face-to-face. There is a website which is used as an adjunct to face to face therapy which parents and children are encouraged to use at home in order to practice skills taught in sessions. All face to face sessions will involve one therapist, the child and a parent/carer present. All sessions will be held at the University of Technology Sydney.

Intervention code [1] 313877 0
Treatment: Other
Intervention code [2] 313916 0
Behaviour
Comparator / control treatment
Wait-list control group.
Participants in the wait-list control group will complete an initial assessment session, wait ten weeks, and the complete a follow up assessment session. There will not be a three and 12 month follow up for those in the wait list group. Following participants completing the follow up assessment session after 12 weeks, they will receive the ten weekly therapy sessions.
Control group
Active

Outcomes
Primary outcome [1] 319360 0
The primary outcome of the trial is to evaluate the effect of the Fearless Me! therapy program on anxiety, for children and adolescents with an intellectual disability. Change in anxiety will primarily be assessed by the Spence Anxiety Scale (child and parent versions), visual analogue scale, and Developmental Behaviour Questionnaire.
Timepoint [1] 319360 0
Post treatment (12 weeks), 3 month follow up, 12 month follow up
Secondary outcome [1] 367894 0
The secondary outcome of the trial is to evaluate the effect of the Fearless Me! therapy program on quality of life, for children and adolescents with an intellectual disability. Changes in quality of life will primarily be assessed by the Paediatric Quality of Life Inventory (Peds-QL; parent version).
Timepoint [1] 367894 0
Post treatment (12 weeks), 3 month follow up, 12 month follow up
Secondary outcome [2] 368250 0
Another outcome of the trial is to evaluate the effect of the Fearless Me! therapy program on the interference anxiety has in daily life, for children and adolescents with an intellectual disability. This will be assessed by the Child Anxiety Life Interference Scale
Timepoint [2] 368250 0
Post treatment (12 weeks), 3 month follow up, 12 month follow up
Secondary outcome [3] 368251 0
Another outcome of the trial is to evaluate the effect of the Fearless Me! therapy program on a child's emotional and social development. This will be assessed using the Strengths and Difficulties Questionnaire, and the Emotions Development Questionnaire
Timepoint [3] 368251 0
Post treatment (12 weeks), 3 month follow up, 12 month follow up

Eligibility
Key inclusion criteria
- aged 8 - 18 years
- clinical or subclinical anxiety
- diagnosed intellectual disability in the mild, moderate or borderline ranges
Minimum age
8 Years
Maximum age
18 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- active suicidality or self harm
- outside of the age range
- anxiety is not the primary concern
- severe intellectual disability

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Who is / are masked / blinded?



Intervention assignment
Other design features
Waitlist control group
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

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] 302167 0
Charities/Societies/Foundations
Name [1] 302167 0
James N Kirby Foundation
Address [1] 302167 0
Level 2/86-90 Bay St, Ultimo NSW 2007
Country [1] 302167 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo NSW 2007
Country
Australia
Secondary sponsor category [1] 302007 0
None
Name [1] 302007 0
Address [1] 302007 0
Country [1] 302007 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302848 0
Human Research Ethics, University of Technology Sydney
Ethics committee address [1] 302848 0
15 Broadway, Ultimo NSW 2007
Ethics committee country [1] 302848 0
Australia
Date submitted for ethics approval [1] 302848 0
Approval date [1] 302848 0
21/11/2018
Ethics approval number [1] 302848 0
ETH18-2384

Summary
Brief summary
This research aims to evaluate the effect of the Fearless Me! program on anxiety for children and adolescents with intellectual disabilities. The Fearless Me! program is a Cognitive Behaviour Therapy treatment which has been specifically adapted for the needs of children with mild and moderate intellectual disabilities. The Fearless Me! program is a weekly, ten session therapy program that aims to teach children and adolescents skills to manage and reduce their anxiety, and involves face to face therapy sessions, as well as an online website to practice skills. It is hypothesised that the program will reduce anxiety for those with clinical or subclinical levels of anxiety, and improve overall quality of life.
Trial website
www.fearlessme.com.au
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91598 0
Ms Anastasia Hronis
Address 91598 0
University of Technology Sydney
15 Broadway
Ultimo NSW 2007
Country 91598 0
Australia
Phone 91598 0
+61403972713
Fax 91598 0
Email 91598 0
anastasia.hronis@uts.edu.au
Contact person for public queries
Name 91599 0
Ms Anastasia Hronis
Address 91599 0
University of Technology Sydney
15 Broadway
Ultimo NSW 2007
Country 91599 0
Australia
Phone 91599 0
+61403972713
Fax 91599 0
Email 91599 0
anastasia.hronis@uts.edu.au
Contact person for scientific queries
Name 91600 0
Ms Anastasia Hronis
Address 91600 0
University of Technology Sydney
15 Broadway,
Ultimo NSW 2007
Country 91600 0
Australia
Phone 91600 0
+61403972713
Fax 91600 0
Email 91600 0
anastasia.hronis@uts.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results