Étude de faisabilité Molehill Mountain : protocole d'un essai pilote non randomisé d'une nouvelle intervention contre l'anxiété fondée sur une application pour les personnes autistes

Titre original en anglais : Molehill Mountain feasibility study: Protocol for a non-randomised pilot trial of a novel app-based anxiety intervention for autistic people

Cette publication est incluse dans le projet « Contributions académiques de personnes autistes sur l’autisme ». un auteur·ice de cette publication est identifié·e comme autiste dans le projet.

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Oakley, B., Boatman, C., Doswell, S., Dittner, A., Clarke, A., Ozsivadjian, A., Kent, R., Judd, A., Baldoza, S., Hearn, A., Murphy, D., Simonoff, E., & Group, T. M. M. A. (2023). Molehill Mountain feasibility study: Protocol for a non-randomised pilot trial of a novel app-based anxiety intervention for autistic people. PLOS ONE, 18(7), e0286792. https://doi.org/10.1371/journal.pone.0286792

Date de publication: 05/07/2023 Ajout dans AutiHub: 25/09/2026 Type: Article Langue de l’article: Anglais
Source éditeur (DOI) Texte intégral Source OpenAlex

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Auteurs

Auteur·ices des publications
13
Auteur·ices de la publication identifié·es comme autistes
1 / 13 (7,7 %)
  1. Bethany Oakley
  2. Charlotte Boatman
  3. Sophie Doswell
  4. Antonia Dittner
  5. Andrew Clarke
  1. Ann Ozsivadjian
  2. Rachel Kent
  3. Adrian Judd
  4. Saffron Baldoza *
  5. Amy Hearn
  1. Declan Murphy
  2. Emily Simonoff
  3. The Molehill Mountain Advisory Group

Résumé

Jusqu'à 50 % des personnes autistes présentent une anxiété concomitante, qui a des répercussions importantes sur leur qualité de vie. Par conséquent, le développement de nouvelles interventions (et/ou l'adaptation de celles existantes) qui améliorent l'anxiété a été indiqué comme une priorité pour la recherche et la pratique cliniques par la communauté autiste. Malgré cela, il existe très peu de thérapies efficaces fondées sur des données probantes, accessibles aux personnes autistes, qui ciblent l'anxiété ; et celles qui sont disponibles (par exemple, la thérapie cognitivo-comportementale adaptée à l'autisme ; TCC) peuvent être difficiles d'accès. Ainsi, l'étude actuelle fournira une preuve de concept précoce concernant la faisabilité et l'acceptabilité d'une nouvelle approche thérapeutique fondée sur une application, qui a été développée avec et adaptée pour les personnes autistes afin de les aider à gérer l'anxiété en utilisant des approches de TCC adaptées recommandées par le National Institute for Health and Care Excellence (NICE) du Royaume-Uni. Cet article décrit la conception et la méthodologie d'un essai pilote non randomisé en cours, approuvé sur le plan éthique (22/LO/0291), qui vise à recruter environ 100 participants âgés de 16 ans ou plus ayant un diagnostic d'autisme existant et des symptômes d'anxiété autoévalués d'intensité légère à sévère (enregistrement de l'essai NCT05302167). Les participants seront invités à utiliser une intervention autonome fondée sur une application, « Molehill Mountain ». Les critères de jugement principaux (Generalised Anxiety Disorder Assessment, Hospital Anxiety and Depression Scale) et secondaires (utilisation de médicaments/services et échelle d'atteinte des objectifs) seront évalués au départ (semaine 2 +/- 2), au terme de l'étude (semaine 15 +/- 2) et lors de trois suivis (semaines 24, 32 et 41 +/- 4). Les participants seront également invités à remplir un questionnaire sur l'acceptabilité de l'application ou à participer à un entretien au terme de l'étude. Les analyses porteront sur : 1) l'acceptabilité, l'utilisabilité et la faisabilité de l'application (au moyen du questionnaire/de l'entretien et des données d'utilisation de l'application) ; et 2) la population cible, la performance des mesures de résultats et le moment/la durée idéaux de l'intervention (au moyen des mesures de résultats principales/secondaires et du questionnaire/de l'entretien), les deux objectifs étant en outre éclairés par un groupe consultatif dédié de parties prenantes. Les données probantes issues de cette étude orienteront l'optimisation et la mise en œuvre futures de Molehill Mountain dans un essai contrôlé randomisé, afin de fournir un nouvel outil facilement accessible aux adultes autistes et susceptible d'améliorer les résultats en matière de santé mentale.

Up to 50% of autistic people experience co-occurring anxiety, which significantly impacts their quality of life. Consequently, developing new interventions (and/ or adapting existing ones) that improve anxiety has been indicated as a priority for clinical research and practice by the autistic community. Despite this, there are very few effective, evidence-based therapies available to autistic people that target anxiety; and those that are available (e.g., autism adapted Cognitive Behavioural Therapy; CBT) can be challenging to access. Thus, the current study will provide an early-stage proof of concept for the feasibility and acceptability of a novel app-based therapeutic approach that has been developed with, and adapted for, autistic people to support them in managing anxiety using UK National Institute for Health and Care Excellence (NICE) recommended adapted CBT approaches. This paper describes the design and methodology of an ethically approved (22/LO/0291) ongoing non-randomised pilot trial that aims to enrol approximately 100 participants aged ≥16-years with an existing autism diagnosis and mild-to-severe self-reported anxiety symptoms (trial registration NCT05302167). Participants will be invited to engage with a self-guided app-based intervention—‘Molehill Mountain’. Primary (Generalised Anxiety Disorder Assessment, Hospital Anxiety and Depression Scale) and secondary outcomes (medication/ service use and Goal Attainment Scaling) will be assessed at baseline (Week 2 +/- 2), endpoint (Week 15 +/- 2) and three follow-ups (Weeks 24, 32 and 41 +/- 4). Participants will also be invited to complete an app acceptability survey/ interview at the study endpoint. Analyses will address: 1) app acceptability/ useability and feasibility (via survey/ interview and app usage data); and 2) target population, performance of outcome measures and ideal timing/ duration of intervention (via primary/ secondary outcome measures and survey/ interview)–with both objectives further informed by a dedicated stakeholder advisory group. The evidence from this study will inform the future optimisation and implementation of Molehill Mountain in a randomised-controlled trial, to provide a novel tool that can be accessed easily by autistic adults and may improve mental health outcomes.

Bibliographie citée par cette référence

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Vue d’ensemble de la bibliographie citée

Ces indicateurs décrivent la bibliographie citée par cette publication. Un nom d’auteurice est compté chaque fois qu’il apparaît dans une référence citée : une même personne peut donc être comptée plusieurs fois. Les noms qui ne sont pas encore associés à un·e auteurice déjà présent·e dans AutiHub sont traités comme inconnus, pas comme non autistes. Dernier calcul : 02/10/2026 01:01.

Références citées
64
Avec un DOI
60
Sans DOI, à partir du texte brut de la bibliographie
4
6 / 64 (9,4 %) références citées comprennent au moins une personne identifiée comme autiste.
Références avec données à compléter
2 / 64 (3,1 %)
Références avec noms d’auteurices détectés
63 / 64 (98,4 %)
Sans nom d’auteurice détecté
1
Sans titre structuré
1
Sans identifiant stable
4
Références avec noms bruts d’auteurices restant à vérifier
0
Références avec problème de récupération des métadonnées externes
1
Ces indicateurs portent sur les références citées affichées sur cette page, après fusion des doublons techniques. Une référence sans DOI peut quand même soutenir les statistiques d’auteurices lorsqu’un titre et des noms d’auteurices sont disponibles.
Noms d’auteurices détectés dans la bibliographie citée
378
À partir du DOI ou de métadonnées externes
378
À partir du texte brut validé de la bibliographie
0
Noms bruts déjà validés
0
Noms bruts restant à vérifier
0
204 / 378 (54,0 %) noms sont associés à un·e auteurice déjà présent·e dans AutiHub. 174 / 378 (46,0 %) noms ne sont pas encore associés.
Noms associés à une personne identifiée comme autiste
18 / 378 (4,8 %)
Calculé sur l’ensemble des noms d’auteurices détectés dans la bibliographie citée. Parmi les noms associés à un·e auteurice déjà présent·e dans AutiHub : 18 / 204 (8,8 %). Personnes distinctes identifiées comme autistes : 14 / 289 (4,8 %).
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