AnxietyNCT04652362
A Single-session Growth Mindset Intervention for Children and Young People With Mental Health Difficulties
A study testing Growth Mindset Online Single-Session Intervention in people with Anxiety and Anxiety Disorders, run by Royal Holloway University at 1 site in United Kingdom.
Trial summary
The present study aims to evaluate whether an online, self-administered, single session intervention (SSI) increases children and adolescents' perceptions of control over external threats and their emotional experience and reduces self-reported symptoms of anxiety and low mood. Read more about this study
- Who is it for?
- Ages 8 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Anxiety Disorders, Depression
- What is being tested?
- Growth Mindset Online Single-Session Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Nov 2020to 1 Dec 2022
- 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 8 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Young person aged between the ages of 8 and 16 years-old
- Young person has difficulties with low mood or anxiety as identified by a parent or caregiver
- Young person has a parent or caregiver willing to take part in the research
- Both the young person and parent must be able to read and understand English to a level enabling them to access the assessment and intervention
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Holloway, University of London
London, TW20 0EX
About this study
Official title: A Single-session Growth Mindset Intervention for Children and Young People With Mental Health Difficulties: a Randomised Controlled Trial
The present study aims to evaluate whether an online, self-administered, single session intervention (SSI) increases children and adolescents' perceptions of control over external threats and their emotional experience and reduces self-reported symptoms of anxiety and low mood. Children and adolescents, identified by their parents as having difficulties with low mood or anxiety, will be randomised to receive either the growth mindset of personality intervention or an active comparison condition. Whether parental low mood and anxiety has a moderating impact on outcomes will also be investigated.
Read the detailed description
Despite considerable evidence for the efficacy of psychological interventions for anxiety and depression in children and young people (CYP) (James et al. 2015; Goodyer, 2017) a significant proportion of CYP fail to access such treatments (Children's Commissioner for England 2016). Reasons for this implementation gap are many but include lack of accessibility to Child and Adolescent Mental Health Services (CAMHS) which are operating with long waiting times, high symptom thresholds and constraints in terms of what they are able to offer (Murphy and Fonagy, 2013). In order to reduce the need to access gap, particularly for young people experiencing symptoms of anxiety and depression but whom may not reach service thresholds, there is a need for the development of novel interventions which are cost-effective and can be disseminated at scale (Milat, King, Bauman, \& Redman, 2012; Kazdin 2019). Single session interventions (SSI), particularly those which can be completed without therapist guidance, offer a scalable solution and have been found to be effective for a range of psychological difficulties in CYP (Schleider \& Weisz 2017). One such SSI targets the implicit beliefs CYP hold about the malleability of their personality (known as their 'mindset') and has been found to reduce adolescent depressive symptoms and parent-reported anxiety over a 9-month period, relative to an active control condition (Schleider and Weisz, 2018). Investigation into trajectories of change found that changes in anxiety and depression were predicted by immediately post intervention changes in perceived primary and secondary control, indicating a potential underlying mechanism. Replication of these findings, along with exploration of predictors of treatment response and diverse opportunities for implementation is required and is the aim of the present study.
This study will test whether an online, self-administered, growth mindset SSI increases perceived primary and secondary control and reduces symptoms of anxiety and depression in children and adolescents aged between 8 and 16, relative to an active "supportive therapy control" condition. Outcome measures will be completed immediately post intervention. A secondary aim for the study will be to investigate the role of parental symptoms of anxiety or low mood as a potential moderator of treatment outcome. In order to achieve these aims, CYP and their parents or caregivers will be recruited through online advertisements, charities and schools.
- Conditions
- Anxiety, Anxiety Disorders, Depression, Low Mood
- Being tested
- Growth Mindset Online Single-Session Intervention, Supportive Therapy Online Single-Session Intervention (Control)
- Keywords
- controlled clinical trials, internet-based intervention
- Medical subject headings
- Anxiety Disorders, Depression, Consciousness Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth Mindset Online Single-Session InterventionBehavioural
During the self-administered single session intervention participants are provided with basic information about the brain and are introduced to the concept of neuroplasticity. The concept of neuroplasticity is applied to personal traits, such as shyness, anxiety and sadness, and young people are taught that these traits are the result of thoughts and feelings in our brain and are amenable to change. Participants are presented with scientific information and research evidence to support the idea that people have the potential to change and are given vignettes from older children detailing how they have used a growth mindset to overcome difficulties. The intervention takes approximately 20-30 minutes to complete.
Supportive Therapy Online Single-Session Intervention (Control)Behavioural
The single session supportive therapy intervention was designed to be structurally comparable to the growth mindset intervention, including the same number of reading and writing activities. Participants were provided with information about emotions and the benefits of expressing emotions. Vignettes from older children described times they had shared their emotions with friends and family members.
| Study group | Role | What they receive |
|---|---|---|
| Growth Mindset Intervention | Experimental | Not described Receives: Behavioral: Growth Mindset Online Single-Session Intervention |
| Supportive Therapy Intervention | Active comparator | Not described Receives: Behavioral: Supportive Therapy Online Single-Session Intervention (Control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Perceived Primary Control Scale for Children; Youth-Report
The Perceived Primary Control Scale for Children (Weisz, Southam-Gerow, \& McCarty, 2001; Weisz, Weiss, Wasserman, \& Rintoul, 1987) measures young people's perceived ability to exert control over situations or events by exerting personal effort. The measure includes 24 statements relating to primary control (e.g. "I can make friends with other kids if I really try" or "I cannot get good grades no matter how hard I try") and respondents are required to rate their agreement with the statement on a Likert scale with responses ranging from "very false" to "very true".
Measured: Immediately pre and post intervention
Change in Perceived Secondary Control Scale for Children; Youth-Report
The Perceived Secondary Control Scale for Children (Weisz, Francis, \& Bearman, 2010) measures young people's perceived ability to control the psychological impact of situations or events through the use of cognitive and behavioural strategies. Participants are required to rate their degree of agreement (on the same scale as the PCSC) to 20 statements regarding secondary control (e.g. "When something bad happens, I can find a way to think about it that makes me feel better" or "When something bad happens, I keep worrying about how bad it is").
Measured: Immediately pre and post intervention
Secondary outcomes (2)
Change in Implicit Theories of Personality Questionnaire; Youth-Report
Young people are asked to rate the extent to which they agree or disagree with three statements about the malleability of their personality on a scale from 1 (really disagree) to 6 (really agree).
Measured: Immediately pre and post intervention
Change in Pediatric Quality of Life Inventory (PEDS-QL) Present Functioning Visual Analogue Scales
The PEDS QL Present Functioning Visual Analogue Scales (Sherman et al. 2006) include four questions assessing young people's current experience of anxiety, sadness, anger and worry. Young people are provided with a scale with a happy face at one end and a sad face at the other end and are asked to move the slider on the scale to the point which best represents how they are feeling at that moment in time.
Measured: Immediately pre and post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2020
- Study start10 Nov 2020
- Primary completion1 Dec 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Why it stopped: Lead researcher off sick
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 AnxietyStudies 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
- Model description
- Participants will be randomly allocated to either the growth mindset intervention or the supportive therapy control condition.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Holloway University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harriet Clarkson, Royal Holloway University
- Investigators
- Harriet Clarkson, Principal investigator, Royal Holloway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652362
- Sponsor's protocol ID
- 2243
- Status last verified
- May 2022
- First submitted
- 26 Nov 2020
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be available on reasonable request
Publications
Schleider JL, Weisz JR. Reducing risk for anxiety and depression in adolescents: Effects of a single-session intervention teaching that personality can change. Behav Res Ther. 2016 Dec;87:170-181. doi: 10.1016/j.brat.2016.09.011. Epub 2016 Sep 26.
PubMed 27697671
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-session Growth Mindset Intervention for Children and Young People With Mental Health Difficulties: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04652362
- Acronym / sponsor ID
- 2243
- Conditions
- Anxiety, Anxiety Disorders, Depression, Low Mood
- Keywords
- controlled clinical trials, internet-based intervention
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Lead researcher off sick
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Royal Holloway UniversityUniversity, hospital or other
- Study start
- 10 Nov 2020 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 3 Dec 2020 (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 present study aims to evaluate whether an online, self-administered, single session intervention (SSI) increases children and adolescents' perceptions of control over external threats and their emotional experience and reduces self-reported symptoms of anxiety and low mood. Children and adolescents, identified by their parents as having difficulties with low mood or anxiety, will be randomised to receive either the growth mindset of personality intervention or an active comparison condition. Whether parental low mood and anxiety has a moderating impact on outcomes will also be investigated.
Detailed description
Despite considerable evidence for the efficacy of psychological interventions for anxiety and depression in children and young people (CYP) (James et al. 2015; Goodyer, 2017) a significant proportion of CYP fail to access such treatments (Children's Commissioner for England 2016). Reasons for this implementation gap are many but include lack of accessibility to Child and Adolescent Mental Health Services (CAMHS) which are operating with long waiting times, high symptom thresholds and constraints in terms of what they are able to offer (Murphy and Fonagy, 2013). In order to reduce the need to access gap, particularly for young people experiencing symptoms of anxiety and depression but whom may not reach service thresholds, there is a need for the development of novel interventions which are cost-effective and can be disseminated at scale (Milat, King, Bauman, \& Redman, 2012; Kazdin 2019). Single session interventions (SSI), particularly those which can be completed without therapist guidance, offer a scalable solution and have been found to be effective for a range of psychological difficulties in CYP (Schleider \& Weisz 2017). One such SSI targets the implicit beliefs CYP hold about the malleability of their personality (known as their 'mindset') and has been found to reduce adolescent depressive symptoms and parent-reported anxiety over a 9-month period, relative to an active control condition (Schleider and Weisz, 2018). Investigation into trajectories of change found that changes in anxiety and depression were predicted by immediately post intervention changes in perceived primary and secondary control, indicating a potential underlying mechanism. Replication of these findings, along with exploration of predictors of treatment response and diverse opportunities for implementation is required and is the aim of the present study.
This study will test whether an online, self-administered, growth mindset SSI increases perceived primary and secondary control and reduces symptoms of anxiety and depression in children and adolescents aged between 8 and 16, relative to an active "supportive therapy control" condition. Outcome measures will be completed immediately post intervention. A secondary aim for the study will be to investigate the role of parental symptoms of anxiety or low mood as a potential moderator of treatment outcome. In order to achieve these aims, CYP and their parents or caregivers will be recruited through online advertisements, charities and schools.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated to either the growth mindset intervention or the supportive therapy control condition.
| Arm | Type | Receives |
|---|---|---|
| Growth Mindset Intervention | Experimental | Behavioral: Growth Mindset Online Single-Session Intervention |
| Supportive Therapy Intervention | Active comparator | Behavioral: Supportive Therapy Online Single-Session Intervention (Control) |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Young person aged between the ages of 8 and 16 years-old
- Young person has difficulties with low mood or anxiety as identified by a parent or caregiver
- Young person has a parent or caregiver willing to take part in the research
- Both the young person and parent must be able to read and understand English to a level enabling them to access the assessment and intervention
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 |
|---|---|---|
| Growth Mindset Online Single-Session InterventionDuring the self-administered single session intervention participants are provided with basic information about the brain and are introduced to the concept of neuroplasticity. The concept of neuroplasticity is applied to personal traits, such as shyness, anxiety and sadness, and young people are taught that these traits are the result of thoughts and feelings in our brain and are amenable to change. Participants are presented with scientific information and research evidence to support the idea that people have the potential to change and are given vignettes from older children detailing how they have used a growth mindset to overcome difficulties. The intervention takes approximately 20-30 minutes to complete. | Behavioural | Growth Mindset Intervention |
| Supportive Therapy Online Single-Session Intervention (Control)The single session supportive therapy intervention was designed to be structurally comparable to the growth mindset intervention, including the same number of reading and writing activities. Participants were provided with information about emotions and the benefits of expressing emotions. Vignettes from older children described times they had shared their emotions with friends and family members. | Behavioural | Supportive Therapy Intervention |
Primary outcome
Change in Perceived Primary Control Scale for Children; Youth-Report
Time frame: Immediately pre and post intervention
The Perceived Primary Control Scale for Children (Weisz, Southam-Gerow, \& McCarty, 2001; Weisz, Weiss, Wasserman, \& Rintoul, 1987) measures young people's perceived ability to exert control over situations or events by exerting personal effort. The measure includes 24 statements relating to primary control (e.g. "I can make friends with other kids if I really try" or "I cannot get good grades no matter how hard I try") and respondents are required to rate their agreement with the statement on a Likert scale with responses ranging from "very false" to "very true".
Change in Perceived Secondary Control Scale for Children; Youth-Report
Time frame: Immediately pre and post intervention
The Perceived Secondary Control Scale for Children (Weisz, Francis, \& Bearman, 2010) measures young people's perceived ability to control the psychological impact of situations or events through the use of cognitive and behavioural strategies. Participants are required to rate their degree of agreement (on the same scale as the PCSC) to 20 statements regarding secondary control (e.g. "When something bad happens, I can find a way to think about it that makes me feel better" or "When something bad happens, I keep worrying about how bad it is").
2 secondary outcomes
Change in Implicit Theories of Personality Questionnaire; Youth-Report
Time frame: Immediately pre and post intervention
Change in Pediatric Quality of Life Inventory (PEDS-QL) Present Functioning Visual Analogue Scales
Time frame: Immediately pre and post intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Background: PubMed 27697671Schleider JL, Weisz JR. Reducing risk for anxiety and depression in adolescents: Effects of a single-session intervention teaching that personality can change. Behav Res Ther. 2016 Dec;87:170-181. doi: 10.1016/j.brat.2016.09.011. Epub 2016 Sep 26.
- Individual participant dataSharing planned: Yes. Data will be available on reasonable request
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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.
Harriet Clarkson principal investigator
Royal Holloway University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Growth Mindset Online Single-Session Intervention in people with Anxiety and Anxiety Disorders, run by Royal Holloway University 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 4 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: paused, as of the sponsor's last update on 12 May 2022. 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?
Results are not available in the source record.
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?
Change in Perceived Primary Control Scale for Children; Youth-Report (time frame: Immediately pre and post intervention). 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?
On the ClinicalTrials.gov record for NCT04652362, 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 12 May 2022; AzTrials last refreshed its copy on 30 Oct 2026.