跳至主要内容
临床试验/NCT04066985
NCT04066985Unknown不适用

Targeting Adolescent Depressive Symptoms: Effects of Two Single-Session, Online Interventions

Child Mind Institute1 个研究点 分布在 1 个国家目标入组 501 人开始时间: 2019年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
501
试验地点
1
主要终点
Change in Mood and Feelings Questionnaire; Youth-Report

研究概览

简要总结

Major depression (MD) in youth is a serious psychiatric illness with extensive morbidity and mortality. The American Academy of Pediatrics recently released practice guidelines promoting primary care (PC)-based youth MD screening; however, even when diagnosed by PC providers, <50% of youth with MD access treatment. Thus, a need exists for interventions that are feasible for youths and parents to access and complete-and that may strengthen parents' likelihood of pursuing longer-term services. Single-session interventions (SSIs) may help forward these goals. SSIs include elements of comprehensive treatments, but their brevity makes them easier to disseminate at scale. Meta-analytic evidence suggests SSIs can reduce youth psychopathology, including self-administered (e.g., online) SSIs. One computer-based SSI, teaching growth mindset (GM; viewing personal traits as malleable), has reduced adolescent depressive symptoms in multiple RCTs. A second computer-based SSI was recently developed to reduce youth depressive symptoms via targeting reductions in self-hate-a symptom identified as important for the maintenance of other depressive symptoms in teenagers. This study will test whether either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or both SSIs reduce symptoms of depression in adolescents, relative to an active "supportive therapy" SSI, which teaches adolescents to share their emotions with trusted others. Youths participating in existing research through the Healthy Brain Network (N=501) will receive either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or the supportive therapy SSI (ST-SSI). The investigators will examine whether the GM-SSI and/or the SK-SSI, versus the ST-SSI will reduce youth depressive symptoms across three months. Results may identify two novel, potent, and brief interventions for adolescent depressive symptoms.

详细描述

Major depression (MD) is the leading cause of disability in youth, with a global economic burden of >$210 billion annually (Whiteford et al., 2013). However, up to 70% of youth with MD do not receive services (Vitiello et al., 2011). Even among those who do access treatment, 30-65% fail to respond (March et al, 2007), demonstrating a significant need for more potent, accessible interventions for adolescent depressive symptoms and disorders.

The goal of this project is to assess the acceptability and effectiveness of two computerized, single-session interventions that may reduce depressive symptoms in adolescents. Single-session interventions (SSIs) have shown promise in preventing and reducing youth mental health problems (see Schleider & Weisz, 2017, for a meta-analysis). The present trial will be the first to evaluate the effectiveness of two distinct SSIs, targeting different types of depressive symptoms, in comparison to an active, previously-established comparison intervention.

The first SSI is designed to instill a growth mindset in youth: the belief that personal behaviors and characteristics, such as depressive symptoms, are malleable rather than fixed (Schleider, Abel, & Weisz, 2015). In previous trial, a single-session growth mindset intervention significantly reduced depressive symptoms in high symptom-adolescents (Schleider & Weisz, 2018); however, questions still remain about the benefits of this intervention across all adolescents.

The second SSI, which has not been tested previously, is designed to strengthen self-kindness and reduce self-hate. This SSI targets self-hate because it is a symptom of depression that has been identified as especially "central," or more important to the maintenance of other kinds of depressive symptoms, in adolescents at-risk for emotional difficulties. Because self-hate is an especially central symptom, an SSI that systematically, precisely reduces it may serve as an especially potent intervention.

This study will test whether either the growth mindset SSI (GM-SSI), the self-kindness SSI (SK-SSI), or both reduces symptoms of depression in adolescents, relative to an active "supportive therapy" SSI, which teaches adolescents to share their emotions with trusted others (Schleider & Weisz 2018). Our second goal is to evaluate whether the GM-SSI and SK-SSI target and specifically improve proximal targets, unique to each SSI, immediately after SSI administration, relative to the comparison intervention (e.g., whether the GM-SSI improves perceived control relative to the comparison intervention, and whether the SK-SSI alters fear of self-compassion relative to the comparison intervention). To test these possibilities, adolescents recruited from the Healthy Brain Network research study (Advarra Pro00012309) (N=501, 167 per SSI condition; ages 11-17) will be randomized to one of three intervention conditions: the web-based GM-SSI; the web-based SK-SSI; or the web-based, supportive therapy (control) SSI, which has been validated previously (Schleider & Weisz, 2016; Schleider & Weisz, 2018). Adolescents will report on their depression symptoms, perceived control, self-compassion, and related domains of functioning at pre-intervention, post-intervention, and at three-month follow-up. The investigators predict the growth mindset and self-kindness web-based interventions will both lead to larger reductions in adolescent depression symptoms relative to the control intervention. Additionally, the investigators predict that the growth mindset SSI will lead to larger reductions in perceived control than the supportive therapy intervention, and that the self-kindness SSI will lead to larger reductions in fear of self-compassion relative to the control program. Results may identify two novel, potent, and brief interventions for adolescent depressive symptoms.

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

Neither investigators, outcomes assessor, youth, nor parents will know the condition assigned to the youth.

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Healthy Brain Network study participants
  • Between the ages of 11-17 (inclusive)
  • Fluent in English

排除标准

  • Youth with parent-reported intellectual disability

研究组 & 干预措施

Growth Mindset Intervention

Experimental

Includes one online, single-session program, the Growth Mindset Program. The 30-minute, self-administered youth program includes: An introduction to the brain and a lesson on neuroplasticity; Testimonials from older youths who describe their views that traits are malleable, due to the brain's plasticity; Further stories by older youths, describing times when they used "growth mindsets" to persevere during social/emotional setbacks; Study summaries noting how/why personality can change; And an exercise in which youths write notes to younger students, using scientific information to explain people's capacity for change.

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

Self-Kindness Intervention

Experimental

Includes one online, single-session program, the Self-Kindness Program. The 30-minute, self-administered youth program includes: An introduction to the science behind why adolescents might think disliking themselves is necessary for success and thus fear self-compassion; Scientific evidence and testimonials from other teens that being self-compassionate actually predicts being more successful socially and academically; Evidence-based tips for overcoming common, fear of self-compassion based obstacles to self-compassion in day to day life; And an exercise in which youths write notes to younger students, using scientific information to explain the benefits of using self-kindness.

干预措施: Self-Kindness Online Single-Session Program (Behavioral)

Supportive Therapy Intervention

Active Comparator

Includes one online, single-session active comparator program, the Supportive Therapy Intervention. The ST SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. The 30-minute, self-administered control group program includes: vignettes written by older youths who describe times when they benefited from sharing their feelings with friends or family; the same number of reading and writing activities as the web-based growth mindset intervention. However, the only goals of the ST intervention are to encourage youths to identify and express feelings to close others; the intervention does not teach or emphasize specific skills or beliefs.

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

结局指标

主要结局

Change in Mood and Feelings Questionnaire; Youth-Report

时间窗: [Baseline to 3-month follow-up.]

Youth-report measure of youth depressive symptoms. Youth rate 33 items reflecting internalizing symptoms on a 0-2 scale. Scores range from 0-66, with higher scores indicating greater symptom severity.

次要结局

  • Change in Self-Hate Scale; Youth-Report(Baseline to post-intervention; baseline to 3-month follow-up.)
  • Change in Screen for Child Anxiety and Related Disorders; Youth-Report(Baseline to 3-month follow-up.)
  • Change in Secondary Perceived Control Scale for Children; Youth-Report(Baseline to post-intervention; baseline to 3-month follow-up.)
  • Change in Implicit Theories of Personality Questionnaire; Youth-Report(Baseline to post-intervention; baseline to 3-month follow-up.)
  • Change in Self-Judgment Subscale of Self-Compassion Scale; Youth-Report(Baseline to post-intervention; baseline to 3-month follow-up.)
  • Change in Fear of Self-Compassion Scale; Youth-Report(Baseline to post-intervention; baseline to 3-month follow-up.)
  • Change in Beck Hopelessness Scale-Short Version; Youth-Report(Baseline to post-intervention; baseline to 3-month follow-up.)
  • Change in Primary Perceived Control Scale for Children; Youth-Report(Baseline to post-intervention; baseline to 3-month follow-up.)

研究者

发起方
Child Mind Institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验