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临床试验/NCT04719949
NCT04719949已完成不适用

Investigating the Effects of Youth Life Experiences on Reward and Cognitive Processes in Brief Interventions for Adolescent Depression

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2021年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
42
试验地点
2
主要终点
Reward responsiveness immediately post-intervention

研究概览

简要总结

The primary objective of this research is to examine two brief interventions for depression, Behavioral Activation (BA), and Problem Solving Therapy (PST), to investigate whether exposure to adverse childhood experiences influences change in the hypothesized target treatment mechanisms linked to each intervention. Research suggests that the treatment targets of BA (reward processing) may be well-matched for youths exposed to childhood adversity, due to disruptions in reward that are linked with adversity exposure. The investigators will examine the effects of youths' adverse life experiences on change in reward-related treatment targets in BA, and compare this to change in the treatment targets of PST, executive functioning processes. The first aim is to investigate the effects of childhood adversity on change in target treatment mechanisms in BA and PST. The second aim is to test whether changes in reward processes is specific to BA, and not PST, among youths exposed to adversity. The third aim is to test the match of BA for depression among youths exposed to adversity, by examining whether BA results in greater reductions in depression symptoms among youths with greater adversity exposure. The investigators will also test whether greater change in reward in associated with greater depression symptom reductions in BA, and not PST.

详细描述

ASSESSMENT: Adolescents and a parent that is able to provide consent for participation will be contacted by research staff to discuss the research project and determine interest in study participation. With verbal permission from the parent, both the parent and adolescent will complete an eligibility screener over the phone. The eligibility screener includes demographic information, psychiatric history, and current depression symptoms (adolescent-report Patient Health Questionnaire-9 and the parent-report Children's Depression Inventory-2) to confirm that interested families meet initial inclusion criteria.

Baseline Assessment. A baseline assessment will be scheduled with all families. Informed consent and assent will be obtained prior to the start of any baseline assessment activities.

A diagnostic interview (Kiddie Schedule for Affective Disorders and Schizophrenia: K-SADS-P/L) will be completed by a trained study staff member with each adolescent and their consenting parent. Diagnoses will be based on consensus ratings between adolescents and parents. Study staff will also administer the pediatric Columbia Suicide Severity Rating Scale, the Depression Rating Scale (embedded in K-SADS-P/L), and the Stress and Adversity Inventory (STRAIN).

Participants and parent will complete self-report questionnaires assessing depression symptom severity, sleep behavior, family and participant demographics, pubertal development, behavioral activation, and problem solving strategies and efficacy.

The Wechsler Abbreviated Scale for Intelligence-II (WASI-II), the Cambridge Neuropsychological Test Automated Battery (CANTAB), and reward processing outcome tasks will be administered to the adolescent by study staff in the lab setting.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
12 Years 至 15 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Elevated depressive symptoms (PHQ-9 ≥ 7, confirmed by clinician rating on the Depression Rating scale)
  • IQ (Intelligence Quotient) ≥ 70

排除标准

  • Intellectual Disability, Pervasive Developmental Delay, or Autism Spectrum Disorders
  • Bipolar Disorder
  • Substance dependence or abuse
  • History of psychosis
  • Medical illness affecting measurement of cognitive and behavioral processes

结局指标

主要结局

Reward responsiveness immediately post-intervention

时间窗: Immediately post-intervention

This primary outcome measure, a response reversal task, is a computerized behavioral task assessing reward processing probabilistically. The task presents adolescents with pairs of pictures on the screen and instructs them to choose one. They receive feedback that their choice is correct or incorrect, and one pictures if positively reinforced 80% of the time. The probabilities change during the task, such that the picture that was rewarded as correct 80% of the time changes to be incorrect 80% of the time. Indices of this task estimate adolescents' responsiveness to changing reward probabilities based on how quickly (learning rate) they learn the change in contingencies.

Reward sensitivity immediately post-intervention

时间窗: Immediately post-intervention

This primary outcome measure, the Balloon Analogue Risk Task, is a computerized behavioral task assessing reward sensitivity. The task allows adolescents a choice regarding the amount of effort they want to exert to obtain a reward (points/cash) in a game where they must titrate their effort to maximize the likelihood of obtaining a reward. The primary index is the average amount of effort (pumps on a balloon) on trials where a reward is earned.

Executive functioning (task-switching total incorrect)

时间窗: Immediately post-intervention

This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Multitasking Test (MTT) assesses task-switching and requires participants to switch between one or multiple tasks when tracking the position of a stimulus on the screen, with the total number of trials with incorrect responses as a primary index. Lower scores at post-intervention compared to pre-intervention indicate improvement (score range=0-160).

Executive functioning (task-switching reaction latency)

时间窗: Immediately post-intervention

This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Multitasking Test (MTT) assesses task-switching and requires participants to switch between one or multiple tasks when tracking the position of a stimulus on the screen, with the median latency to response (reaction time) as primary index. Lower scores at post-intervention compared to pre-intervention indicate improvement (score range=100-2000).

Executive functioning (planning total)

时间窗: Immediately post-intervention

This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Stockings of Cambridge (SOC) task assesses planning and problem-solving strategies used to match a set of shapes on-screen to varied pre-set patterns of stimuli. The number of problems that the participants complete with the minimum number of moves is a primary index. Better scores indicate more efficient planning, better scores at post-intervention than pre-intervention indicate improvement (score range=0-12).

Executive functioning (planning moves)

时间窗: Immediately post-intervention

This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Stockings of Cambridge (SOC) task assesses planning and problem-solving strategies used to match a set of shapes on-screen to varied pre-set patterns of stimuli. The mean number of moves that a participant requires to complete the problems is a primary index. Lower scores indicate more efficient planning, lower scores at post-intervention than pre-intervention indicate improvement (score range=5-12).

Executive functioning (planning initial thinking time)

时间窗: Immediately post-intervention

This primary outcome measure assesses executive function and is a computerized task from the validated Cambridge Neuropsychological Test Automated Battery (CANTAB). The Stockings of Cambridge (SOC) task assesses planning and problem-solving strategies used to match a set of shapes on-screen to varied pre-set patterns of stimuli. The difference in the time taken to select the first move in the "problem solve" vs. "follow" conditions is a primary index. Lower scores indicate more efficient planning, lower scores at post-intervention than pre-intervention indicate improvement (minimum score = 0, maximum score = N/A).

次要结局

  • Change in clinician-rated depression symptoms from baseline to one-month follow-up(Pre-intervention vs. 1-month post-intervention)
  • Change in self-reported depression symptoms from baseline to one-month follow-up(Pre-intervention vs. 1-month post-intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Rachel Vaughn-Coaxum

Assistant Professor

University of Pittsburgh

研究点 (2)

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