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临床试验/NCT05988138
NCT05988138已完成不适用

Reward Responsiveness as a Prevention Target in Youth At Risk for Anhedonia

Vanderbilt University1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2023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
已完成
入组人数
73
试验地点
1
主要终点
Neural responses to rewards measured by electroencephalogram (EEG) in a computerized guessing reward task (physiological measure)

研究概览

简要总结

This trial will test the effects of a positive emotion-focused preventive intervention on reward responsiveness in children of mothers with histories of depression and anhedonia.

详细描述

This study will test the effects of a dyadic preventive intervention, Family Promoting Positive Emotion (F-PPE), for 8- to 12-year-old children of mothers with a history of major depressive disorder (MDD) with anhedonia. The study will first test F-PPE effects on child reward responsiveness (R61), and pending evidence of target engagement, effects on real-world experience of interest/pleasure and clinical symptoms of anhedonia will be evaluated in a second, larger clinical trial (R33). F-PPE was designed to increase child positive valence systems function through mother-child training in behavioral and cognitive skills to increase pleasant activities and attention towards/savoring the positive, individual and dyadic goals, and skills practice. For the R61 phase, eligible child participants (N=60 intervention completers) will complete an EEG assessment of neural reward responsiveness pre- and post-intervention, as well as halfway through the intervention (4 weeks) to determine dose effects. Children and their biological mothers will be randomly assigned to 8 sessions of F-PPE or a psychoeducation comparison condition (groups will be matched on child sex and baseline RewP). Both interventions will be administered through individual telehealth sessions with a masters- or doctoral-level clinician under the supervision of the PIs. To ensure treatment fidelity, videotaped sessions will be reviewed for adherence to the protocol, clinicians will participate in weekly group supervision, and supervisors will randomly review recorded sessions for ratings of treatment adherence.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • Biological mothers with past or current MDD with anhedonia and their 8- to 12-year-old children
  • Child and biological mother can read and speak fluently in English
  • Child and mother have access to a computer or tablet and internet for videoconferencing
  • For compensation purposes, child and biological mothers must be U.S. citizens

排除标准

  • Children with past or current major depressive disorder (MDD) and/or anhedonia lasting most of the day, nearly every day for at least 2 weeks based on semi-structured interviews will be excluded
  • Mothers or children with intellectual or developmental disabilities
  • Mothers with past 6 months substance use disorder with moderate or greater severity
  • Children or mothers with a lifetime history of a manic or hypomanic episode/bipolar disorder
  • Children or mothers with a psychotic disorder (e.g., schizophrenia)
  • Children or mothers with visual or hearing impairments that interfere with completing study measures and sessions
  • Child offspring of a mother who has previously participated in the study with another biological child
  • Children taking medications for emotional or behavioral problems other than SSRIs (stable dose for 6 weeks before time of enrollment) or psychostimulants

研究组 & 干预措施

Family Promoting Positive Emotions

Experimental

干预措施: Family Promoting Positive Emotions (Behavioral)

Psychoeducation

Active Comparator

干预措施: Psychoeducation (Behavioral)

结局指标

主要结局

Neural responses to rewards measured by electroencephalogram (EEG) in a computerized guessing reward task (physiological measure)

时间窗: 4 and 8 weeks

The reward positivity (RewP) component will be measured using EEG with an established computerized guessing reward task ("Doors" task). EEG data will be processed using best practices and the RewP component will be exported from the EEG data approximately 250-350 ms after feedback presentation at the electrode Cz. RewP scores will be quantified as the relative neural response to reward vs. loss feedback.

次要结局

未报告次要终点

研究者

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

Autumn Kujawa

Associate Professor

Vanderbilt University

研究点 (1)

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