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临床试验/NCT04652362
NCT04652362暂停不适用

A Single-session Growth Mindset Intervention for Children and Young People With Mental Health Difficulties: a Randomised Controlled Trial

Royal Holloway University1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2020年11月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
发起方
入组人数
150
试验地点
1
主要终点
Change in Perceived Secondary Control Scale for Children; Youth-Report

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

Participants will not be informed about the contents of the two different programmes and therefore will be blind to group allocation. Randomisation, questionnaire and intervention delivery will be fully automated through the Qualtrics platform and therefore researchers will also be blind to group allocation.

入排标准

年龄范围
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

Growth Mindset Intervention

Experimental

干预措施: Growth Mindset Online Single-Session Intervention (Behavioral)

Supportive Therapy Intervention

Active Comparator

干预措施: Supportive Therapy Online Single-Session Intervention (Control) (Behavioral)

结局指标

主要结局

Change in Perceived Secondary Control Scale for Children; Youth-Report

时间窗: 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").

Change in Perceived Primary Control Scale for Children; Youth-Report

时间窗: 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".

次要结局

  • Change in Implicit Theories of Personality Questionnaire; Youth-Report(Immediately pre and post intervention)
  • Change in Pediatric Quality of Life Inventory (PEDS-QL) Present Functioning Visual Analogue Scales(Immediately pre and post intervention)

研究者

发起方
Royal Holloway University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Harriet Clarkson

Trainee Clinical Psychologist

Royal Holloway University

研究点 (1)

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