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Courage Quest Plus: Testing an optimal way of conducting exposure treatment for children with anxiety

Courage Quest Plus: Testing the optimal method of conducting exposure treatment for symptom reduction and remission in children with anxiety

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623001256662
Enrollment
37
Registered
2023-12-05
Start date
2024-07-10
Completion date
Unknown
Last updated
2025-09-08

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 overarching goal of this research is to improve the efficacy of exposure by optimising a digital exposure-focused intervention (the Courage Quest intervention). This intervention (named Courage Quest Plus) is for children aged 8 to 12 years with one or more anxiety disorders. We are aiming to answer the following research question: Testing Courage Quest Plus. What is the optimal method of delivery of exposure? More specifically, what are the key features that optimise outcomes of exposure, i.e., lead to greatest reductions in anxiety symptoms and remission of anxiety and related disorders, as conducted via the Courage Quest Plus intervention, in children aged 8 to 12 years. We aim to evaluate this through using a fractional factorial design. Although we cannot test all optimization features in one study, we will test 5 features based on the literature in a fractional factorial design, i.e., i) expectancy violation, ii) positive affect, iii) parent training, iv) relaxation, and v) rewards. We hypothesise that the optimal intervention includes expectancy violation, positive affect, parent training, and attachment-based rewards, and does not include relaxation.

Interventions

Brief Name: Courage Quest Plus: Testing an optimal way of conducting exposure treatment for children with anxiety Feature 1: Parent training Feature 2: Relaxation Feature 3: Positive affect Feature 4: Expectancy violation Feature 5: Rewards What: Courage Quest Intervention: Courage Quest Plus is based on the Courage Quest intervention, which is a 10-week digital intervention that aims to equip children and their parents with strategies to overcome child anxiety. It takes the form of a web- an

Brief Name: Courage Quest Plus: Testing an optimal way of conducting exposure treatment for children with anxiety Feature 1: Parent training Feature 2: Relaxation Feature 3: Positive affect Feature 4: Expectancy violation Feature 5: Rewards What: Courage Quest Intervention: Courage Quest Plus is based on the Courage Quest intervention, which is a 10-week digital intervention that aims to equip children and their parents with strategies to overcome child anxiety. It takes the form of a web- and mobile-based website. Parents complete a basic training module within the Courage Quest intervention to familiarise themselves with the app and activities. The training module comprises information about how to use the app and some psychoeducation for parents. Subsequently, both parents and children will then access the intervention content which includes more psychoeducation (e.g., learning about anxiety) and graded exposure (e.g., facing fears and worries gradually). The content is delivered through weekly modules. Participants will complete the intervention over a 10-week period (approximately 20 minutes to 1.25 hours per week). The weekly module may take longer if a participant is allocated to a condition that requires extra information, i.e., positive affect, parent training, and relaxation modules. The parent and child complete the content together on an internet-enabled device (e.g., laptop or tablet). The content will be delivered in the form of videos, brief text with auditory explanations, and examples. The child and parent will be presented with activities and “digital worksheets” to complete online. In the first few modules, participants will set up their exposures. Prior to completing each exposure exercise, participants will be asked to complete a feelings rating, indicating how anxious they feel at that moment (from 1-8). Participants then conduct their exposure and are shown the feeling scale again. Participants have 1 week to complete weekly modules. Adherence will be assessed at the post-intervention survey. Parents will be asked what strategies they used to help their child complete exposures, through a multiple choice question. They will also be asked a free text question to assess if they used other strategies they were not assigned to in their condition. Furthermore, during the second and third therapist calls (see procedures section below for more information), the therapist will also ask the open-ended question of “Is there anything you did to help your child get through exposure”, as an additional integrity check. Courage Quest Plus Intervention: Participants in the Courage Quest Plus intervention will complete Courage Quest plus up to five additional features. These features are summarised below. 1. The parent training feature will involve enhancing parenting training by including more videos and role-plays for the parent to practice delivery of exposure. This will be done by adding role-play videos for the parent to watch and additional written instructions and examples for parents. 2. The positive affect feature will involve the induction of positive mood prior to the exposure. We will provide a series of short funny clips or one longer video for the child to watch just before the exposure practice. 3. The relaxation feature will provide families with breathing exercises to use before the exposure. This involves teaching children how to train their attention to their breath, which can improve physiological responses to stress. 4. The expectancy violation feature will add questions to the delivery of the exposure practice to consciously state the expected outcomes and probability of outcome prior to the exposure and then reflect on actual outcomes and probability after the exposure. 5. In the rewards feature, participants will score points when completing modules and completing exposure tasks. Subsequently, participants will be able to use their points to claim rewards. Participants who are not in the rewards condition will be given basic instructions on giving their child labelled praise, and will be asked to not provide rewards for progress in this intervention. Procedures: Participants will be asked to complete screening questions to assess eligibility. If eligible, participants will then be given the consent form, asked some risk screening questions. After this, participants will be asked to complete a diagnostic interview online for a final eligibility check. If eligible, participants will complete a baseline assessment. Then, they will be instructed to download the Courage Quest Plus website on their device and complete the intervention over 10 weeks. After the last intervention module, participants will then complete a post-intervention assessment (including outcome measures and diagnostic interview). Participants will also complete the diagnostic interview and outcome measures again at 6-month follow-up. Clinician support will also be provided to parents via 3 x 20 minute telephone/telehealth conversations to problem solve any difficulties the families may be experiencing with the program. These support sessions will be scheduled via email at a time convenient to the parent after the first, fifth, and tenth weeks. Design: The study involves a fractional factorial design with five features. There are a total of 2^5 = 32 conditions possible. We, however, removed any conditions with both positive affect and relaxation as we did not believe that these two conditions would have any added benefit beyond each alone. Furthermore, this would reduce the burden on participants as it would be difficult to deliver both during exposure sessions. Omitting these conditions yielded a final total of 24 conditions, detailed below. Condition 1: Courage Quest only Condition 2: Courage Quest + EV Condition 3: Courage Quest + PA Condition 4: Courage Quest + RX Condition 5: Courage Quest + RW Condition 6: Courage Quest + PT Condition 7: Courage Quest + EV + PA Condition 8: Courage Quest + EV + RX Condition 9: Courage Quest + EV + RW Condition 10: Courage Quest + EV + PT Condition 11: Courage Quest + PA + RW Condition 12: Courage Quest + RX + RW Condition 13: Courage Quest + PA + PT Condition 14: Courage Quest + RX + PT Condition 15: Courage Quest + RW + PT Condition 16: Courage Quest + EV + PA + RW Condition 17: Courage Quest + EV+ PA + PT Condition 18: Courage Quest + EV+ RX+PT Condition 19: Courage Quest + EV + RX + RW Condition 20: Courage Quest +EV + RW + PT Condition 21: Courage Quest + PA + RW +PT Condition 22: Courage Quest + RX + RW+ PT Condition 23: Courage Quest + PT + EV + PA + RW Condition 24: Courage Quest + PT + EV + RX + RW Who provided: The intervention is a parent-guided online intervention. However, clinician support to parents will be provided by an AHPRA-registered psychologist. How: The intervention will be delivered online through an app that can be accessed over the internet. It will be provided individually. Where: As part of this trial, the intervention will be available to any families who meet eligibility within Australia. Participants will be able to complete the intervention in their own homes or places of convenience. When and how much: The intervention includes one module per week over 10-weeks, with each module taking approximately 20 minutes to 1.25 hours per week. The time differences will depend on what condition the participant is in, such that the module may take longer if a participant is allocated to a condition that requires extra information, including positive affect, parent training, and relaxation. Participants will also be directed to conduct exposure exercises as home tasks between sessions, though the amount of time spent on this will be dependent on each participant. How well: App usage data will be collected through direct export from the Courage Quest Plus intervention. This will serve as a measure of treatment fidelity. Furthermore, therapist support sessions will be audio-recorded (with the participant’s consent) and a proportion of the sessions will be transcribed (approximately 25%) by independent raters so that the research team can ensure the integrity and consistency of therapist support sessions.

Sponsors

UNSW Sydney
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
8 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

• Child aged 8 to 12 years • Child diagnosed with one or more anxiety disorders and/or obsessive-compulsive disorder (as determined on an online version of the ADIS-5) • Capacity to answer questions independently or with assistance if needed e.g., sufficient English comprehension capacity to complete the study Inclusion criteria for parents: - Parent of a child who meets inclusion criteria above - Capacity to support their child through the intervention e.g., sufficient English comprehension capacity to complete the study

Exclusion criteria

• Child has a primary diagnosis of oppositional defiant disorder or conduct disorder (i.e., most interfering diagnosis) (as determined by the ADIS-5) • Child has a primary diagnosis of attention deficit hyperactivity disorder (as determined by the ADIS-5) • Child has a diagnosed intellectual disability (as determined by parent self-report) that prevents them using the program • Child is currently receiving any psychological therapy for anxiety (other than school counsellor support), i.e., seeing a psychologist for anxiety and/or using a CBT-based program (e.g., Cool Kids or BRAVE) for anxiety (as determined through parent self-report). o Note: child will be eligible if they are receiving other types of (i.e., non-CBT-based) psychological treatment, including supportive counselling, and treatment for other difficulties (i.e., not anxiety) o Note: child will be eligible if their medication is stable across the intervention • Child is reported to have life-threating suicidal ideation and/or had serious suicidal ideation in the last month (as determined by parent self-report). A clinician (Dr Francis, Dr Sicouri, Dr Aji, Dr Chen, or Prof Hudson) will also complete a risk assessment follow-up with parents. This follow-up will occur via telephone within 72 hours of the self-report. • Child is reported to be at imminent and significant risk of harm, including experiencing child abuse and neglect. If indicated, psychologists will complete a risk assessment and comply by mandatory reporting guidelines. • Previously or currently completing the Courage Quest pilot study or efficacy trial.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026