Neural Mechanisms of Evidence-Based, Family-Focused Treatment for Youth Depression: Preliminary Open Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Children's Self Report of Depressive Symptoms
研究概览
简要总结
The goal of this interventional study is to compare the baseline neural mechanisms and parenting in depressed and non-depressed children and to examine baseline neural mechanisms and parenting as predictors of Family-Focused Treatment for Childhood-Depression (FFT-CD) outcomes. The main questions it aims to answer are:
- What are differences between depressed and non-depressed participants on baseline neural and parenting indicators?
- Do baseline neural and parenting indicators predict response to FFT-CD?
- Does change in parenting and neural functioning mediate change in depression from baseline to follow-up?
Participants will:
- complete baseline clinical measures
- complete neuroimaging tasks via Functional Magnetic Resonance Imaging (fMR)
- undergo a 12-session course of FFT-CD
- complete follow up evaluations and neuroimaging
详细描述
Childhood-onset depression is impairing, often recurrent and persistent, and negatively impacts development, resulting in high personal, social, and economic costs. Family-Focused Treatment for Childhood-Depression (FFT-CD) was developed to address the needs of depressed youth. In a large, randomized controlled trial, FFT-CD was superior to individual therapy in promoting recovery from depression.
Despite its promise, there was high variability in degree of improvement in FFT-CD. Our long-term goal is to integrate parenting, neuroimaging and clinical measures to a) reveal the parenting, emotional and neural mechanisms of clinical benefit for FFT-CD and (b) examine what parent and child characteristics predict immediate and long-term benefit. The proposed study will provide groundwork for this larger study by providing preliminary data.
This study will enroll 40 children (ages 7-12) - 20 with current depressive disorder and 20 with no history of mental health disorder -- and their parents (40 parents total). At baseline parents and children will participate in (a) an evaluation of clinical state and family functioning, (b) functional neuroimaging procedures to evaluate neural response to emotional cues (faces), potential reward, and parent-child relations, and resting state-connectivity, and (c) structural imaging (MRI and diffusion tensor imaging). Participants with depressive disorders and their parents will then be provided a 12-session course of FFT-CD. Brief clinical and parenting data will be collected at two points during treatment; baseline procedures will be repeated at 4 months (post-treatment). The participants will engage in briefer clinical evaluation via telehealth 6 and 9 months post-treatment.
Goals include: 1) To examine differences between depressed and non-depressed participants in baseline neural and parenting. 2) To examine baseline neural functioning, emotional experience, and parenting as predictors of FFT-CD outcome in our depressed group. 3) To evaluate parenting and emotional experience across treatment and neural functioning measures at the end of treatment as mediators of change in depression from baseline to final follow-up.
The neuroimaging hypotheses include:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children must:
- •Have a current DSM-5 diagnosis of MDD, Persistent DD, or DDNOS (based on K-SADS-PL) OR not meet criteria for any DSM-5 mental health diagnosis (based on K-SADS-PL)
- •Be ages 7-12
- •Be living with a parent(s) or guardian willing to participate
- •Be able and willing to provide informed consent/assent
- •Parent must:
- •Not be currently pregnant
- •Be able to read, understand consent forms, and provide consent on their child's behalf
- •Be the biological parent (or grandparent in parental role) of the participating child & have lived with the child for more than 75% of the child's life.
- •All participants must:
- •Not have a disturbance that would interfere with participation such as autism spectrum disorder, psychosis, current substance dependence, current use of psychotropic medication, OCD, or MRI contraindication such as metal inside the body or claustrophobia
- •Be proficient in English
排除标准
- •Thought or other disturbance in the child that would interfere with the ability to participate in treatment or assessments (e.g., psychotic disorder, autism spectrum disorder, OCD, active substance abuse/dependence, intellectual disability, as assessed on KSADS-PL)
- •Severe conduct disorders in the child that threaten the home stability (e.g. juvenile justice or children's protective service involvement as assessed on KSADS-PL) due to the potential impact on retention
- •Youth or primary caregivers do not speak English
- •Either parent or child has contraindications for neuroimaging (e.g., claustrophobia, metal implants, braces, electronically, magnetically, or mechanically activated devices such as cochlear implants)
- •The child is on an antidepressant medication, as it may complicate neuroimaging interpretation.
研究组 & 干预措施
Depressed Group
20 children with depression and their parents (40 participants total) will undergo a 12-session course of FFT-CD.
干预措施: Family-Focused Treatment for Childhood-Depression (FFT-CD) (Behavioral)
结局指标
主要结局
Children's Self Report of Depressive Symptoms
时间窗: 4 months
Children's Depression Inventory (CDI) is a 28-item self-report measure. Scores range from 0 to 54 with higher scores reflecting higher levels of symptoms.
Depression Treatment Response
时间窗: 4 months (post-treatment)
\>/= 50% reduction on Children's Depression Rating Scale-Revised (CDRS-R). Scores on this measure range from 17 to 113, and higher scores indicate greater depression severity.
次要结局
- Depression Remission(4 months)