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Is adapted group cognitive behavioural therapy effective in treating anxiety for children and adolescents with intellectual disabilities?

Is adapted group cognitive behavioural therapy effective in treating anxiety for children and adolescents with intellectual disabilities?

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12620000399998
Enrollment
6
Registered
2020-03-23
Start date
Unknown
Completion date
2020-04-30
Last updated
2021-02-16

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

Conditions

None listed

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.

Interventions

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

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?

Sponsors

University of Technology Sydney
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

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

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.

Exclusion criteria

High risk. No access to a computer or tablet. No anxiety. Severe or profound intellectual disability.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026