Child Sexual Abuse, Confirmed, SequelaNCT05006053
i-Minds Professional Stakeholders Qualitative Study
An observational study of Child Sexual Abuse, Confirmed, Sequela, run by Sandra Bucci at 4 sites in United Kingdom.
Trial summary
The main aim of this study is to understand healthcare professionals' perceptions, as well as the barriers and enablers (and unintended consequences), relevant to the uptake of the digital intervention and its future integration into existing NHS infrastructure. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Child Sexual Abuse, Confirmed, Sequela
- What is being tested?
- Interviews/Focus groups
- How many people
- 26 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 1 Sep 2021to 31 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Healthcare professionals who work within NHS services in Greater Manchester and Edinburgh that provide mental health and / or sexual assault support to young people (for example, Child and Adolescent Mental Health Services (CAMHS) and Sexual Assault Referral Centres (SARC)) or organisations that provide digital mental health support nationwide to young people (e.g. Kooth)
Who may be able to join
- Participants will be up to 30 healthcare professionals who work within NHS services that provide mental health and / or sexual assault support to young people (for example, Child and Adolescent Mental Health Services (CAMHS) and Sexual Assault Referral Centres (SARC)) or organisations that provide digital mental health support to young people (e.g. Kooth).
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
NHS Lothian
Edinburgh, EH1 3EG
Greater Manchester Mental Health NHS Foundation Trust
Manchester, Lancashire, M13 9WL
Manchester University Foundation Trust
Manchester, Lancashire, M13 9WL
Pennine Care NHS Foundation Trust
Manchester, Lancashire, OL6 7SR
About this study
Official title: A Qualitative Study of Healthcare Professionals' Perceptions About a Digitally Mediated Intervention for Young People Who Have Experienced Online Sexual Abuse and Its Integration Into Existing NHS and E-therapy Infrastructure
The main aim of this study is to understand healthcare professionals' perceptions, as well as the barriers and enablers (and unintended consequences), relevant to the uptake of the digital intervention and its future integration into existing NHS infrastructure. We will use a qualitative study design and utilise semi-structured interviews and focus groups to gather the views and opinions from up to 30 healthcare professionals who work with young people to provide mental health and / or sexual assault care across two sites: Greater Manchester, UK and Edinburgh, Scotland.
- Conditions
- Child Sexual Abuse, Confirmed, Sequela
- Being tested
- Interviews/Focus groups
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interviews/Focus groupsOther
Also called Qualitative Interviews / Focus Groups
Qualitative study (no intervention delivered)
| Study group | Role | What they receive |
|---|---|---|
| Qualitative study with healthcare professionals | Healthcare professionals working in Child and Adolescent Mental Health Services, Sexual Assault Referral Centres or with e-therapy providers Receives: Other: Interviews/Focus groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
i-Minds Professional Stakeholders Qualitative Study
We will conduct semi-structured interviews and focus groups either by phone or online with up to 30 healthcare professionals who work within Child and Adolescent Mental Health Services, Sexual Assault Referral Centres or with an e-therapy provider. We will seek healthcare professionals' perspectives on the development of an online intervention designed to support young people who have experienced online sexual abuse (YP-OSA), including its advantages and disadvantages, how it compares with what services currently offer to YP-OSA, who it might benefit, what it should target, what will encourage or discourage YP to engage in the intervention, and how it could be scaled up and integrated sustainably within existing services. Data will be used to support the design of an online intervention for YP-OSA and the development of study information material and standard operating procedures of the subsequent feasibility study aimed at testing the intervention with YP-OSA.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start1 Sep 2021
- Primary completion31 Jan 2022
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Child Sexual Abuse, Confirmed, SequelaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandra Bucci
- Sponsor type
- University, hospital or other
- Collaborators
- University of Edinburgh, Greater Manchester Mental Health NHS Foundation Trust, NHS Lothian, Pennine Care NHS Foundation Trust, Manchester University NHS Foundation Trust
- Responsible party
- Sponsor-investigator, Sandra Bucci, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006053
- Sponsor's protocol ID
- NIHR131848
- Status last verified
- Dec 2022
- First submitted
- 29 Jul 2021
- Last updated
- 22 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Qualitative research data will be shred within the research team but consent is not being sought to share data outside of the immediate research team
Publications
Bucci S, Varese F, Quayle E, Cartwright K, Larkin A, Chan C, Chitsabesan P, Green V, Hewins W, Machin M, Newton A, Niebauer E, Norrie J, Radford G, Richards C, Sandys M, Selby V, Shafi S, Ward J, Whelan P, Schwannauer M. A digital intervention to improve mental health and interpersonal resilience in young people who have experienced technology-assisted sexual abuse: a feasibility clinical trial. Child Adolesc Ment Health. 2026 Feb;31(1):23-32. doi: 10.1111/camh.70060. Epub 2026 Jan 6.
PubMed 41493931
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Qualitative Study of Healthcare Professionals' Perceptions About a Digitally Mediated Intervention for Young People Who Have Experienced Online Sexual Abuse and Its Integration Into Existing NHS and E-therapy Infrastructure
- ClinicalTrials.gov ID
- NCT05006053
- Acronym / sponsor ID
- NIHR131848
- Conditions
- Child Sexual Abuse, Confirmed, Sequela
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Sandra BucciUniversity, hospital or other
- Collaborators
- University of Edinburgh, Greater Manchester Mental Health NHS Foundation Trust, NHS Lothian, Pennine Care NHS Foundation Trust, Manchester University NHS Foundation Trust
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 31 Jan 2022 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main aim of this study is to understand healthcare professionals' perceptions, as well as the barriers and enablers (and unintended consequences), relevant to the uptake of the digital intervention and its future integration into existing NHS infrastructure. We will use a qualitative study design and utilise semi-structured interviews and focus groups to gather the views and opinions from up to 30 healthcare professionals who work with young people to provide mental health and / or sexual assault care across two sites: Greater Manchester, UK and Edinburgh, Scotland.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Qualitative study with healthcare professionals | – | Other: Interviews/Focus groupsHealthcare professionals working in Child and Adolescent Mental Health Services, Sexual Assault Referral Centres or with e-therapy providers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthcare professionals who work within NHS services in Greater Manchester and Edinburgh that provide mental health and / or sexual assault support to young people (for example, Child and Adolescent Mental Health Services (CAMHS) and Sexual Assault Referral Centres (SARC)) or organisations that provide digital mental health support nationwide to young people (e.g. Kooth)
Key inclusion criteria (1 listed)
- Participants will be up to 30 healthcare professionals who work within NHS services that provide mental health and / or sexual assault support to young people (for example, Child and Adolescent Mental Health Services (CAMHS) and Sexual Assault Referral Centres (SARC)) or organisations that provide digital mental health support to young people (e.g. Kooth).
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interviews/Focus groupsAlso: Qualitative Interviews / Focus GroupsQualitative study (no intervention delivered) | Other | Qualitative study with healthcare professionals |
Primary outcome
i-Minds Professional Stakeholders Qualitative Study
Time frame: 24 weeks
We will conduct semi-structured interviews and focus groups either by phone or online with up to 30 healthcare professionals who work within Child and Adolescent Mental Health Services, Sexual Assault Referral Centres or with an e-therapy provider. We will seek healthcare professionals' perspectives on the development of an online intervention designed to support young people who have experienced online sexual abuse (YP-OSA), including its advantages and disadvantages, how it compares with what services currently offer to YP-OSA, who it might benefit, what it should target, what will encourage or discourage YP to engage in the intervention, and how it could be scaled up and integrated sustainably within existing services. Data will be used to support the design of an online intervention for YP-OSA and the development of study information material and standard operating procedures of the subsequent feasibility study aimed at testing the intervention with YP-OSA.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Derived from this study: PubMed 41493931Bucci S, Varese F, Quayle E, Cartwright K, Larkin A, Chan C, Chitsabesan P, Green V, Hewins W, Machin M, Newton A, Niebauer E, Norrie J, Radford G, Richards C, Sandys M, Selby V, Shafi S, Ward J, Whelan P, Schwannauer M. A digital intervention to improve mental health and interpersonal resilience in young people who have experienced technology-assisted sexual abuse: a feasibility clinical trial. Child Adolesc Ment Health. 2026 Feb;31(1):23-32. doi: 10.1111/camh.70060. Epub 2026 Jan 6.
- Individual participant dataSharing planned: No. Qualitative research data will be shred within the research team but consent is not being sought to share data outside of the immediate research team
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Child Sexual Abuse, Confirmed, Sequela, run by Sandra Bucci at 4 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
i-Minds Professional Stakeholders Qualitative Study (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022; AzTrials last refreshed its copy on 26 Oct 2026.