i-Minds: a digital intervention for young people exposed to online sexual abuse
| ISRCTN | ISRCTN43130832 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43130832 |
| IRAS number | 301517 |
| Secondary identifying numbers | IRAS 301517, CPMS 51349 |
- Submission date
- 21/03/2022
- Registration date
- 12/04/2022
- Last edited
- 25/11/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Online sexual abuse (OSA) of young people has increased, can have serious effects on their development and mental health, and has become an important priority for health and social care services. The National Institute for Health and Care Excellence (NICE) has recognised the identification of effective interventions for improving the wellbeing of young people who have experienced OSA and preventing further harm as a research priority. Young people can report OSA to government agencies and social media companies, but there are currently few tried and tested (evidence-based) or helpful treatments available. The NHS urgently needs an accessible intervention to support young people who have experienced OSA. Interventions aimed at improving mentalisation (the ability to understand one's own thoughts and feelings and those of others) is increasingly applied to treat young people with varied mental health difficulties. Young people who have experienced OSA are reluctant to seek in-person support and are generally comfortable receiving online support. A digital intervention aimed at improving mentalisation in OSA may reduce the risk for future harm and help young people become more resilient and able to manage distress that might result from OSA experiences.
Who can participate?
Young people aged 12-18 years who have experienced OSA that has led to distress who are receiving support from a service such as the NHS or Kooth for their mental health, though OSA does not necessarily have to be the primary focus of their support.
What does the study involve?
Participants use an app-based intervention over the period of 6 weeks. The intervention is largely based on mentalisation approaches which aim to boost the ability to understand the mental states of oneself and others. This approach has seen increasing application in the support of young people's mental health. The purpose of the i-Minds app is to help people better mentalise and therefore make them less vulnerable to the ongoing risk of online harm and further re-victimisation online. It is not intended to prevent or treat a medical condition.
What are the possible benefits and risks of participating?
The study hopes that the intervention may reduce distress by supporting young people to develop their mentalisation capacity and gain valuable psychoeducational insight into OSA and how best to avoid further re-victimisation in the future. Whilst all possible steps have been implemented to ensure the safety of young people taking part in the study, it is possible that when accessing the materials in the app, young people may become upset due to reliving memories of the OSA. Appropriate support will be provided throughout the study and there are a number of methods used in the app to help calm and soothe young people if they start to feel upset.
Where is the study run from?
University of Manchester (UK)
When is the study starting and how long is it expected to run for?
March 2018 to April 2023
Who is funding the study?
National Institute for Health Research (NIHR) (UK)
Who is the main contact?
Prof. Sandra Bucci
sandra.bucci@manchester.ac.uk
Contact information
Principal Investigator
School of Psychological Sciences
University of Manchester
2nd Floor, Zochonis Building
Brunswick Street
Manchester
M13 9PL
United Kingdom
 ORCID ID |
0000-0002-6197-5333 |
|---|---|
| Phone | +44 (0)1613060422 |
| sandra.bucci@manchester.ac.uk |
Study information
| Study design | Multi-center non-randomized mixed methods feasibility clinical trial and nested qualitative study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | i-Minds: a digital intervention to improve mental health and interpersonal resilience for young people who have experienced online sexual abuse - a non-randomised feasibility clinical trial and nested qualitative study |
| Study acronym | i-Minds |
| Study hypothesis | As this is a feasibility clinical trial, there are no a-priori hypotheses. Instead, the study aims to determine the feasibility, acceptability and usability of the digital intervention (an app) and how to best integrate the app into existing routine care pathways. |
| Ethics approval(s) |
Approved 15/12/2021, West of Scotland Research Ethics Committee 4 (Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0213; WestofScotland.ResearchEthicsCommittee4@ggc.scot.nhs.uk), ref: 21/WS/0160 |
| Condition | App-based support for young people who have experienced distress associated with online or technology-facilitated sexual abuse |
| Intervention | Non-randomised mixed methods feasibility clinical trial with all participants receiving the intervention (novel app-based intervention using a mentalisation-based approach to improve resilience and reduce risk of re-victimisation and further harm associated with online sexual abuse). The intervention window is 6 weeks. |
| Intervention type | Other |
| Primary outcome measure | 1. Feasibility of delivering the app will be assessed via recruitment and retention data congruent with all relevant fields of the CONSORT statement for feasibility studies. Assessment will take place across the recruitment and data collection period (months 1-11 of trial). 2. Usability, safety and acceptability: 2.1. Usability assessed by the proportion of participants who complete intervention, dropout rates, reason for withdrawal, app usage and engagement (using secure software analytics guided by AMUsED framework) 2.2. Safety assessed using detailed adverse events/serious adverse events reports 2.3. Acceptability assessed using in-depth interviews with trial participants (YP-OSA) to examine whether expectations met, level of support needed to engage with the app, overall impressions, likes/dislikes about the app, how it helped/did not help, changes required, barriers to participation/engagement. Assessment will take place across the recruitment and data collection period (months 1-11 of trial). |
| Secondary outcome measures | 1. Exploration of whether the app brings about clinically meaningful change in outcomes, measured via a battery of questionnaires measuring mentalisation, problematic internet use, emotional distress, online abuse-related stress, emotion regulation, interpersonal sensitivity, views/attitudes towards close interpersonal relationships and resilience, app satisfaction. Assessment will take place at baseline (pre-app use) and post 6-week intervention window (post-treatment). 2. Exploration of differences in engagement and potential clinical benefit across key demographic groups, measured by a registration form requesting demographic (e.g. gender, ethnicity, age, sexual orientation, internet use, level of social deprivation) and clinical (e.g. diagnosis, treatment regime in referring service, other sources of support) details. Assessed at baseline. 3. Exploration of barriers and enablers to app integration and uptake into existing National Health Service (NHS) Child & Adolescent Mental Health Services (CAMHS) & Sexual Assault Referral Centres (SARC) and e-therapy provider pathways, assessed with qualitative interviews with healthcare professionals and service managers from referring services to examine ways to maximise uptake, utility, user experience, acceptability, satisfaction, reach of the app; how the app can be locally adapted and translated into practice; referral routes to the app via existing care pathways; strategic perceptions about whether the app can be scaled up. This will be assessed throughout the data collection period. |
| Overall study start date | 13/03/2018 |
| Overall study end date | 30/04/2023 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 46 |
| Participant inclusion criteria | 1. 12-18 years old 2. Have been exposed to online sexual abuse and report associated distress 3. Are receiving support from NHS CAMHS, SARC or e-therapy providers (Kooth) and will continue to be actively supported by the service over the duration of the trial 4. Willing to use an app designed to support YP-OSA 5. Proficient in speaking and writing in English 6. Have the capacity to consent 7. Consent to providing their username to the research team (Kooth participants only) |
| Participant exclusion criteria | 1. Have insufficient verbal and written command of English 2. Have moderate learning difficulties (as assessed by their direct care team) 3. Are at risk of current or recent (past month) suicidality |
| Recruitment start date | 01/05/2022 |
| Recruitment end date | 31/03/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Bury New Road
Prestwich
Manchester
M25 3BL
United Kingdom
Ashton-under-lyne
OL6 7SR
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
London
W2 6LG
United Kingdom
Sponsor information
Hospital/treatment centre
Trust Headquarters
Bury New Road
Prestwich
Manchester
M25 3BL
England
United Kingdom
| Phone | +44 (0)161 773 9121 |
|---|---|
| sarah.leo@gmmh.nhs.uk | |
| Website | https://www.gmmh.nhs.uk// |
"ROR" |
https://ror.org/05sb89p83 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/05/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | 1. Academic publications (peer-reviewed publications) 2. The researchers also aim to share findings with as many people as possible, including young people (YP) themselves, caregivers, mental health services, police, schools and education services, industry and voluntary sector organisations, and the general public. 3. Stakeholder conferences and presentations at academic conferences. 4. NIHR Health and Social Care Delivery Research (HSDR) final report 5. Project website, digital media animation to promote project visibility 6. Social media platforms: the researchers will advertise the study on the Greater Manchester Mental Health Complex Trauma and Resilience Research Unit (GMMH C-TRU) research unit Twitter feed. 7. Practitioner and public forums: Co-I EQ is a member of the Child Dignity Alliance Working Group (aligned to the #WeProtect Global Alliance), providing a route to disseminate our findings in the wider international child protection community and influence the potential for scaling up the research outputs to a global audience. 8. Events: conferences, network meetings, webinars and symposia. The researchers plan to host PPI engagement conferences in partnership with their advisory groups, and a stakeholder conference/cross-sectoral workshop to present and discuss the findings of this research. They will invite several national-level NHS representatives (Public Health Leads, DoH Directors of Mental Health, Public Health England) and agencies that have an online presence to explore avenues for potential uptake. 9. Leverage stakeholder contacts: the researchers will share results in accessible digital formats through partner sites and activities, youth-led initiatives and influence policy and practice through direct contact with NHS partners and governments. They will invite their collaborator YP and digital collaborators to share project findings through their multimedia channels and networks. 10. Government/policy development: the researchers will engage with the Home Office Child Protection Groups and the Scottish Government during stakeholder/network events as well as reporting findings into the revised national strategy on sexual assault referral centres (SARCs) through NHSE CYP Mental Health Policy Team and the Health and Justice Team. The researchers already have membership of key online child protection working groups within the Home Office and the Scottish Government that will enable this. Their NCA–CEOP collaborator will play a central role in disseminating information to YP/practitioners on online safety and well-being, and Childnet International who work directly with YP, parents/caregivers, teachers and professionals and are the UK Safer Internet Centre Hub. |
| IPD sharing plan | Future requests to access data will be via the project’s CI (Prof. Sandra Bucci; sandra.bucci@manchester.ac.uk) and will be only approved on a case-by-case basis when sharing of data will not incur any risk of participant identification, and only when secondary users will be from a bona fide research organisation and have been granted suitable regulatory approval to further interrogate the data. The exact procedures for accessing the final datasets, as well as relevant meta-data and statistical code used in all quantitative analyses, will be approved by the PSC and made available to prospective future users upon request addressed to the CI and in keeping with our ethical approvals. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 3 | 09/05/2022 | 07/03/2023 | No | No |
| Protocol article | protocol | 21/03/2023 | 24/03/2023 | Yes | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Other publications | 28/03/2024 | 02/04/2024 | Yes | No | |
| Basic results | 25/11/2024 | No | No |
Additional files
Editorial Notes
25/11/2024: The following changes were made
1. Total final enrolment added.
2. The Intention to publish date was changed from 01/05/2024 to 01/05/2025.
3. Basic results added.
02/04/2024: Publication reference added.
24/03/2023: Publication reference added.
07/03/2023: Protocol uploaded (not peer reviewed).
06/05/2022: The trial website has been added.
04/04/2022: Trial's existence confirmed by the West of Scotland Research Ethics Committee 4.
