Clinical trial NCT04652362: A Single-session Growth Mindset Intervention for Children and Young People With Mental Health Difficulties
Official title: A Single-session Growth Mindset Intervention for Children and Young People With Mental Health Difficulties: a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Anxiety
Anxiety Disorders
Depression
Low Mood
Keywords: controlled clinical trials
internet-based intervention
Lead sponsor: Royal Holloway University
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 150
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated to either the growth mindset intervention or the supportive therapy control condition.
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Perceived Primary Control Scale for Children; Youth-Report
timeFrame: Immediately pre and post intervention
measure: Change in Perceived Secondary Control Scale for Children; Youth-Report
timeFrame: Immediately pre and post intervention
Secondary outcomes:
measure: Change in Implicit Theories of Personality Questionnaire; Youth-Report
timeFrame: Immediately pre and post intervention
measure: Change in Pediatric Quality of Life Inventory (PEDS-QL) Present Functioning Visual Analogue Scales
timeFrame: Immediately pre and post intervention
Other outcomes:
measure: Revised Children's Anxiety and Depression Scale (RCADS); Parent-Report
timeFrame: Completed by parents pre-intervention
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Completed by parents pre-intervention
measure: Generalized Anxiety Disorders Scale (GAD 7)
timeFrame: Completed by parents pre-intervention
measure: Participant feedback
timeFrame: Immediately post intervention
Locations:
city: London
country: United Kingdom
facility: Royal Holloway, University of London
Study officials:
affiliation: Royal Holloway University
name: Harriet Clarkson
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.