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Fearless Me!: A Pilot Randomised Controlled Trial (RCT) of an Innovative Treatment Program for Children with Intellectual Disability and Anxiety

Fearless Me!: A Pilot Randomised Controlled Trial (RCT) of an Innovative Treatment Program for Children with Intellectual Disability and Anxiety

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619000434190
Enrollment
10
Registered
2019-03-18
Start date
2019-02-21
Completion date
2019-08-01
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

University of Technology Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Primary purpose
Treatment

Eligibility

Sex/Gender
All
Age
8 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

- aged 8 - 18 years - clinical or subclinical anxiety - diagnosed intellectual disability in the mild, moderate or borderline ranges

Exclusion criteria

- active suicidality or self harm - outside of the age range - anxiety is not the primary concern - severe intellectual disability

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026