NCT05302167

Molehill Mountain Feasibility Study.

Feasibility Study of an Adapted App-based Anxiety Intervention ('Molehill Mountain') for Autistic People.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: King's College London · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

Up to half of autistic people experience anxiety symptoms, which can have a significant impact on everyday wellbeing. However, there are currently very few effective, evidence-based interventions to support autistic people in managing anxiety; and many autistic people face barriers in accessing inperson health and social care services. Therefore, developing new interventions (and/ or adapting existing ones) that improve anxiety, in a way that meets the needs of autistic people, represents the autism community's number one priority for research and clinical practice. Addressing this priority, the investigators will test the acceptability and feasibility of a new, app-based therapeutic approach for anxiety ('Molehill Mountain') that has been developed with, and adapted for, autistic people aged 12-years and over using adapted Cognitive Behavioural therapy principles. This means that information will be collected from autistic people accessing clinical services on whether they would choose to use the anxiety app, whether the app is simple to administer and use, how it is used, how it can be improved, and whether it is effective in reducing anxiety symptoms and/ or enhancing other outcomes, such as everyday wellbeing and functioning. The evidence from this project will inform the future optimisation and implementation of Molehill Mountain in a randomised-controlled trial, with the ultimate aim of transforming long-term healthcare delivery for autistic people.

Conditions

• Anxiety
• Autism

Interventions

Type	Name	Description
BEHAVIORAL	Molehill Mountain app	The Molehill Mountain app (currently Version 2) was developed jointly by King's College London (Lead: Prof Emily Simonoff; Advisors: Dr Ann Ozsivadjian and Dr Rachel Kent) and UK autism charity Autistica (Product Owner: Andy Clarke; Product Designer: Joanna Alpe) for use by autistic people aged ≥12-years (https://www.autistica.org.uk/molehill-mountain). The app was designed based on a self-guided paper-and-pencil CBT toolkit adapted for autism by Professor Emily Simonoff. Since the first version of Molehill Mountain (a two-week long programme) was launched in 2016, and based on surveys of autistic people and five rounds of prototype testing, the Molehill Mountain V2 app was relaunched in April 2021 as a three-month long app-based programme with enhanced interactive features. This 3-month V2 Molehill Mountain app, with enhanced interactive features supporting short daily logins, that will be implemented in the current study.
DEVICE	Molehill Mountain app	As above.

Timeline

• Start date: 2022-09-06
• Primary completion: 2024-10-24
• Completion: 2024-10-24
• First posted: 2022-03-31
• Last updated: 2024-10-26

Locations

2 sites across 1 country: United Kingdom