Helping GPs in Ireland support young people's mental health: A pilot study of an online training programme
| ISRCTN | ISRCTN18075379 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18075379 |
| Sponsor number | TRI-CRF-25-04 |
| Sponsor | Trinity College Dublin |
| Funders | Irish College of General Practitioners, Irish Network of Healthcare Educators, Irish Medical Council, HSE National Office of Suicide Prevention, Trinity College Dublin School of Medicine, Trinity College Dublin Office of the Dean of Research |
- Submission date
- 15/01/2026
- Registration date
- 09/03/2026
- Last edited
- 10/03/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Other
Plain English summary of protocol
Background and study aims
There has been an increase in mental health presentations among young people in Ireland over the past 10 years and recent reports suggest this has been exacerbated during and following the Covid-19 pandemic. GPs are often the first point of contact for Adolescent Mental Health (AMH) presentations and form a critical point in the care pathway. However, many GPs do not feel equipped to confidently deal with adolescents presenting with mental health issues.
An online educational intervention for GPs on the topic of Adolescent Mental Health has being developed by the research team. This research study is taking place to evaluate the online educational intervention exploring the impact of the educational intervention on GPs’ awareness, practice, and self-perceived knowledge and confidence in relation to Adolescent Mental Health presentations. The study is being carried out to determine the feasibility of delivering and implementing this new online educational intervention and to explore its impact.
Who can participate?
The eligibility criteria for this study are:
1. General Practitioner currently active in clinical practice
2. The GP must be practicing within the Republic of Ireland
3. ICGP member
What does the study involve?
This study is a pilot randomised controlled trial that will last 3 months for participants. This means that participants will be randomly allocated to either an intervention group (which will receive the training on Adolescent Mental Health during the study) or a control group (which will receive the training on Adolescent Mental Health after the study is complete). This study involves participants completing online questionnaires on the topic of Adolescent Mental Health. These questionnaires will be administered using a TCD Licenced Qualtrics platform.
What are the possible benefits and risks of participating?
While taking part in this study may not directly benefit participants, their participation will help the research team to understand more about how GPs can support young people who are concerned about their mental health. It will inform educational policy and practice for GPs to effectively manage Adolescent Mental Health at primary care level. GPs will be able to use this training towards their annual CPD requirements.
There are no direct risks to taking part in this study. Some GPs may find the issues raised in the online training uncomfortable or upsetting. However, there is a low probability of this transient risk of harm occurring given that GPs are very familiar with receiving training on challenging clinical situations and sensitive topics. Participants will be given a short list of contacts at the end of the online module and encouraged to make contact with them if they have been affected by any of the topics raised during the training.
There is a risk that a connection could be made to the identity of the participant from a data breach. Great care will be taken to ensure the confidentiality of all information and the risk to participants of a breach of confidentiality is considered very low.
Where is the study run from?
Discipline of Public Health and Primary Care, Institute of Population Health, School of Medicine, Trinity College Dublin, Russell Centre, Tallaght Cross, D24 DH74.
When is the study starting and how long is it expected to run for?
The study will start in February 2026 and run until February 2027.
Who is funding the study?
The research study is funded by:
1. The Irish College of General Practitioners through their Research and Education Grant Scheme. The HSE National Office of Suicide Prevention and the Irish College of General Practitioners also funded the development of the online educational intervention.
2. The Irish Network of Healthcare Educators and the Irish Medical Council, through their Research in Medical Education Award Scheme.
3. The TCD School of Medicine and TCD Office of the Dean of Research through their TCD MED Research Impact Award Scheme.
Who is the main contact?
The main contact for this study is Dr. Dónal Wallace (wallacd1@tcd.ie)
Contact information
Principal investigator, Scientific, Public
Discipline of Public Health and Primary Care, Institute of Population Health, School of Medicine, Trinity College Dublin, Russell Centre, Tallaght Cross
Dublin
D24 DH74
Ireland
 ORCID ID |
0000-0001-6998-6726 |
|---|---|
| Phone | +353 1 896 3737 |
| wallacd1@tcd.ie |
Study information
| Primary study design | Interventional | |
|---|---|---|
| Allocation | Randomized controlled trial | |
| Masking | Open (masking not used) | |
| Control | Uncontrolled | |
| Assignment | Parallel | |
| Purpose | Health services research | |
| Participant information sheet | 48845 GP Participant PIL Version 3 14.3.25.pdf | |
| Scientific title | Promoting AdolesCEnt Mental Health through GP training (PACE-GP): A pilot RCT and process evaluation of an online educational intervention designed to support GPs in Ireland to manage adolescent mental health presentations | |
| Study acronym | PACE-GP | |
| Study objectives | 1. To conduct a pilot RCT of an online educational intervention to evaluate the impact of the intervention on participating GPs’ awareness, practice, and self-perceived knowledge and confidence. 2. To evaluate the potential for wider implementation of the GP educational intervention using the Medical Research Council process evaluation components of recruitment, context, implementation and mechanism of impact. 3. To produce and disseminate outputs of this study to the project’s target audiences through national and international communications and dissemination to specific target audiences, using tailored messages and channels for each audience including: GPs, researchers, policy makers, the media and general public. | |
| Ethics approval(s) |
Approved 08/07/2024, Irish College of GPs Research Ethics Committee (Irish College of GPs, 15 Hogan Place, Dublin, D02 DK23, Ireland; +353 1 6763705; research@icgp.ie), ref: ICGP_REC_2024_2002 | |
| Health condition(s) or problem(s) studied | Adolescent mental health (primary care recognition and management) | |
| Intervention | A pilot RCT will be conducted to evaluate the online educational intervention on the topic of Adolescent Mental Health (AMH). Alongside the pilot RCT, the research team will conduct a process evaluation and fidelity assessment of intervention delivery and receipt, to explore the implementation of the intervention. The pilot RCT is first outlined after which the process evaluation is described. PILOT RANDOMISED CONTROLLED TRIAL In the pilot RCT, 120 GPs will be randomly allocated to a control or intervention group, receiving either intervention: new online training on AMH; or control: no online training on AMH. An allocation ratio of 1:1 will be used. Intervention participants will complete a self-reported questionnaire before (Baseline) and immediately after (Time 2) receiving the online training to assess their knowledge, perceived AMH practice, awareness of AMH issues and confidence on a range of issues relating to AMH presentations, with a three-month follow up questionnaire (Time 3). Control participants will receive the questionnaire at Baseline and Time 3. Collection of data at Time 2 in the intervention group is to measure immediate intervention effect but the primary study end-point is at Time 3, three months following randomisation/intervention. Data will be collected from self-report surveys by participating GPs using the Qualtrics survey platform. Questionnaires will be based on an evaluation of an educational tool for Dementia in Australian GPs. All baseline questionnaires will also collect demographic information. As a form of wait list control, GP participants in the control group will be offered access to the intervention at Time 3, once they have completed their 3 month follow up questionnaire. Study Population Approximately 120 GP participants will be recruited to take part, through advertisements on social media, GPbuddy, Forum journal, ICGP Membership ezine email, and at the monthly ICGP Webinar meeting. Randomisation GP participants will be randomised to either the intervention group or control group using the randomiser feature within Qualtrics. Intervention and Intervention delivery The AMH intervention itself consists of an online educational tool for GPs on the subject of Adolescent Mental Health. Content includes core issues around AMH presentations, communication with adolescents, primary care management of AMH presentations and best use of resources as they exist in Ireland currently. It will take approximately 60 minutes for GPs to undertake the training. This intervention has been designed in close consultation with subject matter expert, Dr. Anna Beug, and based on the research team’s findings in the literature review and analysis of the focus group interviews. The intervention will be run through the ICGP Education Platform, the ICGP’s online learning platform. Sample Size Considerations In this pilot RCT, the research team primarily want to assess the feasibility of delivering and implementing the GP AMH online educational tool. While we do not seek to demonstrate the benefit of the intervention, we will consider its potential impact, which will be used to inform a formal sample size calculation for the main trial. The research team will aim to recruit 120 GP participants as based on similar work by Eldridge et al. and our prior experience, this would be a large enough sample to inform feasibility of delivering and implementing this intervention. Blinding Blinding of participant GPs will not be possible due to the nature of the intervention. The trial statistician will not be blinded to GP participant group allocation for practical reasons. Recruitment Approximately 120 GP participants will be recruited to take part, through advertisements on social media, GPbuddy, Forum journal, ICGP Membership ezine email, and at the monthly ICGP Webinar meeting. The advertisement will contain a link to Qualtrics. Within Qualtrics participants will be able to view the Participant Information Leaflet and then complete the consent form. We will aim to recruit 30 GP participants per month over a 4 month period. Description of Study Procedures Once the consent form is completed by GP participants within Qualtrics, they will be asked to complete a Baseline questionnaire which will also include demographic questions. After participants have completed the Baseline questionnaire, the randomiser feature within Qualtrics will be used to allocate participants to either the control or intervention group, and participants will be advised what group they have been assigned to. The Intervention group will receive an email from the PI within 7 days containing the link to the online educational tool. Participants will be asked to complete the training within 3 weeks. If participants have not completed the training within 3 weeks, they will be emailed a maximum of up to 2 reminders by the PI. At the end of the online educational tool, there will be a link to Qualtrics where participants will complete the Time 2 questionnaire. In order for study participants to gain access to the online training module, the PI will email the names of participants to be granted access to the ICGP. Participants in the Intervention group will be given access to the online training within 1 week of completing their Baseline questionnaire. Following completion of the Baseline questionnaire the Control Group participants will be advised that they have been allocated to the Control group. 3 months post randomisation all participants in both the Control and Intervention groups will receive an automated email from Qualtrics with a link to the Time 3 questionnaire. Continuation Criteria The research team will use formal continuation criteria to determine if progressing this pilot RCT to a definitive pragmatic RCT is warranted based on data from the pilot RCT and process evaluation. The criteria for continuation (also referred to as progression criteria) will be based around pre-determined measures of feasibility, including participant recruitment, retention, data collection and the potential for intervention effectiveness. These continuation criteria will be monitored by the research team and will determine whether the ongoing trial is feasible to continue. PROCESS EVALUATION Alongside the pilot RCT, we will conduct a process evaluation and fidelity assessment of intervention delivery and receipt, involving GPs who received the online educational training, to explore the implementation of the intervention from multiple perspectives in line with the MRC Framework for the Process Evaluation of Complex Interventions. The following issues surrounding integration, context, fidelity, implementation and experiences of the intervention will be explored as part of the process evaluation. For the process evaluation, the 60 GP participants who received the educational intervention will also complete questionnaires (in the same questionnaire as the one used for the pilot RCT) at Time 2 and Time 3 that assess ratings of acceptability and appropriateness and will be invited to provide free-text comments reflecting on their immediate experience of the intervention. Quantitative data will be summarised with descriptive statistics and thematic analysis will be conducted for the qualitative data. At Time 3, all participants will be asked if they completed any other training on AMH in the preceding 3 months. Both the quantitative and qualitative results will inform the Continuation Criteria outlined above. The PPI advisors will be involved in establishing what would be seen as indicators of acceptability and in interpretation of process evaluation findings. | |
| Intervention type | Behavioural | |
| Primary outcome measure(s) |
| |
| Key secondary outcome measure(s) |
| |
| Completion date | 30/11/2026 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | All |
| Target sample size at registration | 120 |
| Key inclusion criteria | 1. General Practitioner currently active in clinical practice 2. The GP must be practicing within the Republic of Ireland 3. ICGP member 4. Age 18 years old or over |
| Key exclusion criteria | 1. Not active in clinical practice 2. Not practicing in the Republic of Ireland 3. Not an ICGP member 4. GP trainee |
| Date of first enrolment | 24/03/2026 |
| Date of final enrolment | 31/07/2026 |
Locations
Countries of recruitment
- Ireland
Study participating centre
Dublin
D24 DH74
Ireland
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Anonymised datasets generated during and/or analysed during the current study will be available upon request from study PI Dr. Dónal Wallace (wallacd1@tcd.ie) on completion of the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other files | GENERAL PRACTITIONER CONSENT FORM version 3 |
06/06/2025 | 15/01/2026 | No | No |
| Participant information sheet | Information Leaflet for General Practitioners version 3 |
14/03/2025 | 15/01/2026 | No | Yes |
| Protocol file | version 4 | 04/10/2025 | 15/01/2026 | No | No |
Additional files
- 48845 GP Participant PIL Version 3 14.3.25.pdf
- Information Leaflet for General Practitioners
- 48845 GP Consent Form V3 6.6.25.pdf
- GENERAL PRACTITIONER CONSENT FORM
- 48845 Protocol for pilot RCT and process evaluation Version 4 - 4.10.25.pdf
- Protocol file
Editorial Notes
10/03/2026: The date of first enrolment was changed from 02/03/2026 to 24/03/2026.
15/01/2026: 1. Trial's existence confirmed by Irish College of GPs
2. The study had REC amendments approved on 15/7/25. Further REC amendments were also approved on 30/10/25.
