Anxiety Disorders and SymptomsNCT05676554
The Efficacy of a Growth-Mindset Intervention for Adolescents: A Randomised Controlled Trial
A study testing An Enhanced Psychological Mindset Session for Adolescents in people with Anxiety Disorders and Symptoms and Depression, Anxiety, run by University of East Anglia at 1 site in United Kingdom.
Trial summary
This study is exploring an animated learning resource that could be used online to promote mental health. It is computer based and delivered in a single session, lasting 30 minutes. Read more about this study
- Who is it for?
- Ages 14 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders and Symptoms, Depression, Anxiety, Adolescent - Emotional Problem
- What is being tested?
- An Enhanced Psychological Mindset Session for Adolescents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Feb 2023to 23 May 2024
- Phase
- Interventional
- 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 14 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Ages 14-18 years old
- Currently in the United Kingdom
Who cannot join
- Not currently in the United Kingdom
- Participants who cannot read/write English (by self-selecting to take part in the research they will be able to read English sufficiently to continue),
Trial locations and contacts
1 site in 1 country.
About this study
This study is exploring an animated learning resource that could be used online to promote mental health. It is computer based and delivered in a single session, lasting 30 minutes. It teaches young people about thoughts, feelings, personality and the brain, it includes ideas about "mindsets" - or beliefs about the brain - which may be helpful in day-to-day life.
The investigators will use social media to recruit 14-18-year-olds to take part in our research. They will be randomly put into one of two groups - either a group who receive the online session first or a group who receive the session later (at the end of the study).
Read more
The animated learning resource aims to promote and protect mental health. The investigators predict it might have some benefits for emotional wellbeing, though the investigators do not know for certain. Young people who take part might learn something new or find it rewarding to know they have been part of research which could be used to help promote mental health.
It is important to know that this is a research study and not a form of treatment for mental health problems.
Read the detailed description
The study will be advertised on different social media platforms and shared online by the researcher. Participants will be able to click the link for more information where detailed study information will be provided and a link to the study on Qualtrics. The participants will then be able to tick to consent to taking part in the research, then allocated a research identification number which will be linked to their email address.
Once consented demographic information will be collected and baseline measures will be administered (RCADS-11; AFQ-Y8; IPTQ 3 items). Once baseline measures are completed the participants will be randomised by an independent source (via Qualtrics) to either treatment or control (so neither participants or researchers know until after enrolment).
Following randomisation, those who are allocated to the treatment arm will complete 'An Enhanced Psychological Mindset Session for Adolescents' online. A feasibility randomised control trial by Perkins et al. (2021) demonstrated that their enhanced psychological mindset session for adolescents (which is used in this current study) is feasible, acceptable, and potentially scalable. Their single session intervention (SSI) was developed specifically for adolescents and aims to promote emotional wellbeing through encouraging a "growth mindset" as research suggests those with growth mindsets who believe personal traits can change are less likely to experience mental health problems (Schleider et al., 2015).
In total the intervention (watching the video, questions and letter task) takes approximately 30 minutes to complete and the feasibility study took a maximum of 2 hours (including to go through information sheet, consenting process, measures and follow ups). Once the intervention has been completed participants will then be contacted four weeks later for a follow up and asked to complete all measures again. At the end of the trial when all the treatment arm participants have completed the intervention, the control group will be given the link to access it. There will also be a prize draw for those who complete the follow up with a chance to win an amazon voucher (15 £10 vouchers).
- Being tested
- An Enhanced Psychological Mindset Session for Adolescents
- Keywords
- Growth Mindset
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An Enhanced Psychological Mindset Session for AdolescentsOther
It is a ten-minute psychoeducation video (animation) delivered on the internet, followed by five minutes of stories from fictional students about how they used the concepts. Participants then complete three multiple choice questions aimed to assess their understanding and ability to apply concepts from the video, followed by 'letter of advice' task where participants have to give advice to a fictional younger student based on the information presented in the animation and videos.
The intervention itself was developed by Perkins et al (2021) based on promoting a growth mindset. It was deemed to be a feasible and acceptable tool to promote mental health (Perkins et al., 2021) in their feasibility trial.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | This arm will watch the growth mindset session Receives: Other: An Enhanced Psychological Mindset Session for Adolescents |
| Waitlist | No intervention | This arm will receive the intervention once they have completed the follow up at 4 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
11-item Revised Child Anxiety and Depression Scale (RCADS) (Radez et al., 2021)
Measures anxiety and depression symptoms. It contains six items addressing anxiety symptoms and five addressing depression symptoms, with the option of a two-item impact supplement. It is an 11 item self-report measure using a Likert scale from 0 (Never) to 3 (Always). Higher scores indicate higher reported symptoms with cut off scores provided to indicate clinically significant scores. The measure should take less than five minutes to complete
Measured: Baseline
11-item Revised Child Anxiety and Depression Scale (RCADS) (Radez et al., 2021)
Measures anxiety and depression symptoms
Measured: 4 week follow up
Secondary outcomes (4)
Three items from the Implicit Personality Theory Questionnaire (IPTQ) (Yeager et al., 2013)
Three items from the Implicit Personality Theory Questionnaire (IPTQ) will be used to assess participants views on whether personality is fixed or malleable (Yeager et al., 2013) these items are identical to the ones used in the feasibility study. The self-report three items are: "You have a certain personality, and it is something that you can't do much about," "Your personality is something about you that you can't change very much," and "Either you have a good personality or you don't, and there is really very little you can do about it." The items are rated on a Likert scale from 1 (really disagree) to 6 (really agree), with a higher score suggesting a more fixed mindset. This measure should take less than a few minutes to complete.
Measured: Baseline
Three items from the Implicit Personality Theory Questionnaire (IPTQ) (Yeager et al., 2013)
Used to assess participants views on whether personality is fixed or malleable
Measured: 4 week follow up
The Acceptance and Fusion Questionnaire for Youth-Short Form (AFQ-Y8; Greco et al., 2008)
Used to assess psychological flexibility (being present, aware, and accepting of our thoughts and emotions and acting on values rather than short-term impulses [(Hülsheger et al., 2013]), which captures third-wave cognitive behavioural (e.g., Neff, 2003; Hayes et al., 2011) constructs such as acceptance and values-accordant behaviour. This measure was also used in the feasibility study.
The AFQ-Y8 is an eight item self-report measure which uses a Likert scale from 0 (not at all true) to 5 (very true). Possible scores range from 0 to 32. There are no clinical cut off scores, but lower total scores indicate greater psychological flexibility.
Measured: Baseline
The Acceptance and Fusion Questionnaire for Youth-Short Form (AFQ-Y8; Greco et al., 2008)
Used to assess psychological flexibility
Measured: 4 week follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start3 Feb 2023
- Primary completion23 May 2024
- Study completion23 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorders and SymptomsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of East Anglia
- Sponsor type
- University, hospital or other
- Collaborators
- Norfolk and Suffolk NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05676554
- Sponsor's protocol ID
- ETH2223-0067
- Status last verified
- Jun 2024
- First submitted
- 20 Dec 2022
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of a Growth-Mindset Intervention for Adolescents: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05676554
- Acronym / sponsor ID
- ETH2223-0067
- Keywords
- Growth Mindset
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University of East AngliaUniversity, hospital or other
- Collaborators
- Norfolk and Suffolk NHS Foundation Trust
- Study start
- 3 Feb 2023 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 23 May 2024 (actual)
- First posted
- 9 Jan 2023 (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.
This study is exploring an animated learning resource that could be used online to promote mental health. It is computer based and delivered in a single session, lasting 30 minutes. It teaches young people about thoughts, feelings, personality and the brain, it includes ideas about "mindsets" - or beliefs about the brain - which may be helpful in day-to-day life.
The investigators will use social media to recruit 14-18-year-olds to take part in our research. They will be randomly put into one of two groups - either a group who receive the online session first or a group who receive the session later (at the end of the study).
The animated learning resource aims to promote and protect mental health. The investigators predict it might have some benefits for emotional wellbeing, though the investigators do not know for certain. Young people who take part might learn something new or find it rewarding to know they have been part of research which could be used to help promote mental health.
It is important to know that this is a research study and not a form of treatment for mental health problems.
Detailed description
The study will be advertised on different social media platforms and shared online by the researcher. Participants will be able to click the link for more information where detailed study information will be provided and a link to the study on Qualtrics. The participants will then be able to tick to consent to taking part in the research, then allocated a research identification number which will be linked to their email address.
Once consented demographic information will be collected and baseline measures will be administered (RCADS-11; AFQ-Y8; IPTQ 3 items). Once baseline measures are completed the participants will be randomised by an independent source (via Qualtrics) to either treatment or control (so neither participants or researchers know until after enrolment).
Following randomisation, those who are allocated to the treatment arm will complete 'An Enhanced Psychological Mindset Session for Adolescents' online. A feasibility randomised control trial by Perkins et al. (2021) demonstrated that their enhanced psychological mindset session for adolescents (which is used in this current study) is feasible, acceptable, and potentially scalable. Their single session intervention (SSI) was developed specifically for adolescents and aims to promote emotional wellbeing through encouraging a "growth mindset" as research suggests those with growth mindsets who believe personal traits can change are less likely to experience mental health problems (Schleider et al., 2015).
In total the intervention (watching the video, questions and letter task) takes approximately 30 minutes to complete and the feasibility study took a maximum of 2 hours (including to go through information sheet, consenting process, measures and follow ups). Once the intervention has been completed participants will then be contacted four weeks later for a follow up and asked to complete all measures again. At the end of the trial when all the treatment arm participants have completed the intervention, the control group will be given the link to access it. There will also be a prize draw for those who complete the follow up with a chance to win an amazon voucher (15 £10 vouchers).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: An Enhanced Psychological Mindset Session for AdolescentsThis arm will watch the growth mindset session |
| Waitlist | No intervention | –This arm will receive the intervention once they have completed the follow up at 4 weeks. |
Who may qualify
- Ages
- 14 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Ages 14-18 years old
- Currently in the United Kingdom
Key exclusion criteria (2 listed)
- Not currently in the United Kingdom
- Participants who cannot read/write English (by self-selecting to take part in the research they will be able to read English sufficiently to continue),
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 |
|---|---|---|
| An Enhanced Psychological Mindset Session for AdolescentsIt is a ten-minute psychoeducation video (animation) delivered on the internet, followed by five minutes of stories from fictional students about how they used the concepts. Participants then complete three multiple choice questions aimed to assess their understanding and ability to apply concepts from the video, followed by 'letter of advice' task where participants have to give advice to a fictional younger student based on the information presented in the animation and videos. The intervention itself was developed by Perkins et al (2021) based on promoting a growth mindset. It was deemed to be a feasible and acceptable tool to promote mental health (Perkins et al., 2021) in their feasibility trial. | Other | Intervention |
Primary outcome
11-item Revised Child Anxiety and Depression Scale (RCADS) (Radez et al., 2021)
Time frame: Baseline
Measures anxiety and depression symptoms. It contains six items addressing anxiety symptoms and five addressing depression symptoms, with the option of a two-item impact supplement. It is an 11 item self-report measure using a Likert scale from 0 (Never) to 3 (Always). Higher scores indicate higher reported symptoms with cut off scores provided to indicate clinically significant scores. The measure should take less than five minutes to complete
11-item Revised Child Anxiety and Depression Scale (RCADS) (Radez et al., 2021)
Time frame: 4 week follow up
Measures anxiety and depression symptoms
4 secondary outcomes
Three items from the Implicit Personality Theory Questionnaire (IPTQ) (Yeager et al., 2013)
Time frame: Baseline
Three items from the Implicit Personality Theory Questionnaire (IPTQ) (Yeager et al., 2013)
Time frame: 4 week follow up
The Acceptance and Fusion Questionnaire for Youth-Short Form (AFQ-Y8; Greco et al., 2008)
Time frame: Baseline
The Acceptance and Fusion Questionnaire for Youth-Short Form (AFQ-Y8; Greco et al., 2008)
Time frame: 4 week follow up
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 4 Jun 2024.
- Individual participant dataSharing planned: No
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Mental Health
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing An Enhanced Psychological Mindset Session for Adolescents in people with Anxiety Disorders and Symptoms and Depression, Anxiety, run by University of East Anglia at 1 site 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 2 inclusion and 2 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 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
11-item Revised Child Anxiety and Depression Scale (RCADS) (Radez et al., 2021) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Jun 2024.