Condition category
Mental and Behavioural Disorders
Date applied
12/11/2020
Date assigned
23/11/2020
Last edited
04/12/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
COVID-19 presents significant and diverse challenges for young people, and many report feelings of anxiety, loneliness, and a lack of control. Consequently, there is an urgent need for digital tools to support young people’s mental health and wellbeing during this period. Young people often turn to their peers for support and express a preference for peer-to-peer support above other types of support, but currently, there is a lack of evidence-based peer-to-peer interventions.

An online peer support training programme designed to help equip young people with the skills and confidence to provide support to their peers during the COVID-19 pandemic has recently been evaluated. The findings from this indicated that peer support training increased young people’s ability to help others and their perceived ability for civic engagement, as well as their own sense of wellbeing. Following this, the study team worked together with a group of young people who completed this peer support training, and the partner charity Youth Era, to co-design a ‘Coping during COVID-19’ online training course for adolescents.

The ‘Coping during COVID-19’ online training course is aimed at youth who have been particularly affected by the pandemic and is designed to help motivate, empower, and support them to build coping skills and resilience. The course will be delivered online to a class of 60, with small group activities facilitated by young people trained in providing peer support.

This study will evaluate whether this online training course improves young people's wellbeing, connectedness, perceived coping skills, self-esteem, and sense of purpose and meaning, relative to a wait-list control group. The study will also explore the young people’s experiences of receiving the training and self-reported impacts, and the experiences of the youth who deliver the training.

Who can participate?
Young people aged 16-18 years who live in the UK

What does the study involve?
Participants will be randomly allocated to either a training group or a wait-list group. Participants allocated to the training group will complete the online training course, ‘Coping during COVID-19’, delivered over a period of 5 days. The course will be delivered to a total class of 60, and participants will work in small groups of 7, guided by a young person trained in peer support. Participants' wellbeing will be assessed 1 week and 2 weeks later. After the 2-week assessment, the wait-list group will be eligible to receive the training.

What are the possible benefits and risks of participating?
Participants will take part in a co-produced ‘Coping during COVID-19’ online training programme. The programme is designed to help motivate, empower, and support youth to build coping skills and resilience, especially during the COVID-19 pandemic. There are no known risks of participating in the training.

Where is the study run from?
The University of Oxford, Department of Psychiatry (UK). Training will be delivered online. YouthEra (UK) will provide training materials.

When is the study starting and how long is it expected to run for?
From October 2020 to March 2021

Who is funding the study?
Westminster Foundation (UK)

Who is the main contact?
Dr Gabriela Pavarini
gabriela.pavarini@psych.ox.ac.uk

Trial website

https://www.oxneurosec.com/coping

Contact information

Type

Scientific

Primary contact

Dr Gabriela Pavarini

ORCID ID

http://orcid.org/0000-0001-5574-4021

Contact details

University of Oxford
Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
+44 (0)7599480095
gabriela.pavarini@psych.ox.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

Peer-delivered training to improve adolescent wellbeing during the COVID-19 outbreak: a randomised controlled trial

Acronym

Study hypothesis

Does peer delivered training improve adolescents’ wellbeing during the COVID-19 outbreak, relative to a wait-list?

Ethics approval

Approved 10/11/2020, University of Oxford, Medical Sciences Interdivisional Research Ethics Committee (Research Services, University of Oxford, Wellington Square, Oxford, OX1 2JD, UK; +44 (0)1865 616577; ethics@medsci.ox.ac.uk), ref: R69810/RE001

Study design

Randomized controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Internet

Trial type

Quality of life

Patient information sheet

https://www.oxneurosec.com/coping

Condition

Adolescent mental wellbeing during COVID-19

Intervention

Current intervention as of 04/12/2020:
After providing consent and completing baseline measures, an independent researcher will randomise participants to either receive training or to the wait-list using randomisation software. Participants allocated to the training arm will complete an online training course, of 14 h total, delivered over a period of 5 days. Outcomes for both arms will be assessed 1 and 2 weeks.

_____

Previous intervention:
After providing consent and completing baseline measures, an independent researcher will randomise participants to either receive training or to the wait-list using randomisation software. Participants allocated to the training arm will complete an online training course, of 14 h total, delivered over a period of 5 days. Outcomes for both arms will be assessed 1 and 3 weeks post-randomisation.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale at 1 week

Secondary outcome measures

Current secondary outcome measures as of 04/12/2020:
1. Connectedness measured using the Social Connectedness Scale at 1 and 2 weeks
2. Perceived coping skills measured using items adapted from the COVID-19 Adolescent Symptom & Psychological Experience Questionnaire at 1 and 2 weeks
3. Self compassion measured using the Compassionate Engagement and Action Scales-Self-Compassion Scale at 1 and 2 weeks
4. Self-esteem measured using the Self-esteem Scale at 1 and 2 weeks
5. Sense of purpose measured using the Claremont Purpose Scale at 1 and 2 weeks
6. Mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale at 2 weeks

_____

Previous secondary outcome measures:
1. Connectedness measured using the Social Connectedness Scale at 1 and 3 weeks
2. Perceived coping skills measured using items adapted from the COVID-19 Adolescent Symptom & Psychological Experience Questionnaire at 1 week and 3
3. Self compassion measured using the Compassionate Engagement and Action Scales-Self-Compassion Scale at 1 and 3 weeks
4. Self-esteem measured using the Self-esteem Scale at 1 and 3 weeks post-randomisation
5. Sense of purpose measured using the Claremont Purpose Scale at 1 and 3 weeks
6. Mental wellbeing measured using the Warwick-Edinburgh Mental Wellbeing Scale at 3 weeks

Overall trial start date

01/10/2020

Overall trial end date

30/03/2021

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged between 16 and 18 years
2. UK resident
3. Sufficient English level to be able to take the course
4. Able to complete training and measures independently
5. Access to Wi-Fi for the duration of the course
6. Access to a computer, camera, and speakers for the duration of the course
7. Happy to be randomly assigned to one of two iterations of the training course
8. Consent to participate (this includes those aged 16 or 17 who are considered ‘competent youths’ as per best practice guidance 04) and provided baseline measures

Participant type

Healthy volunteer

Age group

Child

Gender

Both

Target number of participants

120

Total final enrolment

94

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

14/11/2020

Recruitment end date

03/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Oxford, Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom

Sponsor information

Organisation

University of Oxford

Sponsor details

Department of Psychiatry
Warneford Hospital
Oxford
OX3 7JX
United Kingdom
+44 (0)1865 618200
information@psych.ox.ac.uk

Sponsor type

University/education

Website

http://www.ox.ac.uk/

Funders

Funder type

Charity

Funder name

Westminster Foundation

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

The full study protocol is not yet available but will be uploaded prior to study completion. Planned publication of the study results in a high-impact peer-reviewed journal.

IPD sharing statement:
The data-sharing plans for the current study are unknown and will be made available at a later date.

Intention to publish date

31/05/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

04/12/2020: The following changes have been made: 1. The recruitment end date has been changed from 24/11/2020 to 03/12/2020. 2. The final enrolment number has been added. 3. The intervention has been changed. 4. The secondary outcome measures have been changed. 5. The plain English summary has been updated to reflect the above changes. 26/11/2020: Internal review. 19/11/2020: Trial’s existence confirmed by University of Oxford.