- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04652362
A Single-session Growth Mindset Intervention for Children and Young People With Mental Health Difficulties
A Single-session Growth Mindset Intervention for Children and Young People With Mental Health Difficulties: a Randomised Controlled Trial
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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London, United Kingdom, TW20 0EX
- Royal Holloway, University of London
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Growth Mindset Intervention
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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.
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ACTIVE_COMPARATOR: Supportive Therapy Intervention
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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".
|
Immediately pre and post intervention
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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").
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Immediately pre and post intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Implicit Theories of Personality Questionnaire; Youth-Report
Time Frame: Immediately pre and post intervention
|
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).
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Immediately pre and post intervention
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Change in Pediatric Quality of Life Inventory (PEDS-QL) Present Functioning Visual Analogue Scales
Time Frame: Immediately pre and post intervention
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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.
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Immediately pre and post intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Revised Children's Anxiety and Depression Scale (RCADS); Parent-Report
Time Frame: Completed by parents pre-intervention
|
The RCADS is a 47-item questionnaire used to screen for symptoms of depression and anxiety in children and adolescents aged 8-18.
The measure yields a Total Anxiety Scale (sum of the 5 anxiety sub scales) and a Total Internalising Scale (sum of all 6 subscales).
A t-score is calculated from the raw score with a t-score of 65 meaning that the score is roughly in the top 7% of scores of un-referred young people of the same age (described as borderline clinical) and a t-score of 70 meaning that the score is roughly in the top 2% (described as the clinical threshold.
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Completed by parents pre-intervention
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Patient Health Questionnaire (PHQ-9)
Time Frame: Completed by parents pre-intervention
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The PHQ-9 (Kroenke, Spitzer & Williams, 2001) is a 9-item diagnostic screening tool used to assess for and monitor the presence of depressive symptomatology in adults.
The questions, which correspond to the diagnostic criteria in DSM-5, ask respondents to quantify the number of days they have been bothered by certain symptoms over the past two weeks.
A higher score indicates greater symptom severity.
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Completed by parents pre-intervention
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Generalized Anxiety Disorders Scale (GAD 7)
Time Frame: Completed by parents pre-intervention
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The GAD-7 (Spitzer et al 2006) is a 7-item questionnaire used to assess for symptoms and severity of generalised anxiety disorder (GAD), however it is also used as a screening tool across anxiety disorders due to the transdiagnostic nature of the items and high degree of comorbidity in anxiety disorders (Kroenke et al 2007).
As with the PHQ-9, respondents are asked to rate the frequency of symptoms over the past two weeks.
A higher score indicates greater symptom severity.
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Completed by parents pre-intervention
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Participant feedback
Time Frame: Immediately post intervention
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Youth will be asked to complete 4 items about their experience of the intervention (e.g.
"I understood the activity") on a 5 point scale ranging from strongly disagree to strongly agree.
Participants are also given the opportunity to complete an additional 3 open-ended questions about their experience.
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Immediately post intervention
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Harriet Clarkson, Royal Holloway University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2243
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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