i-Minds Professional Stakeholders Qualitative Study

December 20, 2022 updated by: Sandra Bucci

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Edinburgh, United Kingdom, EH1 3EG
        • NHS Lothian
    • Lancashire
      • Manchester, Lancashire, United Kingdom, M13 9WL
        • Greater Manchester Mental Health NHS Foundation Trust
      • Manchester, Lancashire, United Kingdom, M13 9WL
        • Manchester University Foundation Trust
      • Manchester, Lancashire, United Kingdom, OL6 7SR
        • Pennine Care NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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)

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Qualitative study with healthcare professionals
Healthcare professionals working in Child and Adolescent Mental Health Services, Sexual Assault Referral Centres or with e-therapy providers
Other: Interviews/Focus groups
Qualitative study (no intervention delivered)
Other Names:
  • Qualitative Interviews / Focus Groups

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sandra Bucci

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Edinburgh
NHS Lothian
Manchester University NHS Foundation Trust
Greater Manchester Mental Health NHS Foundation Trust
Pennine Care NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 16, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 20, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NIHR131848

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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